Clinical Trials List
Protocol NumberCNTO1275SLE2001
2015-10-15 - 2020-06-30
Phase II
Terminated4
Study ended1
ICD-10M32.9
Systemic lupus erythematosus, unspecified
ICD-10M32
Systemic lupus erythematosus (SLE)
A Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study of Ustekinumab in Subjects With Active Systemic Lupus Erythematosus
-
Trial Applicant
Johnson & Johnson
-
Sponsor
Janssen Research & Development
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- WEN-NAN HUANG Division of Rheumatology
- HSIN-HUA CHEN Division of Rheumatology
- 謝佳偉 Division of Rheumatology
- 洪維廷 Division of Rheumatology
- Yi-Hsing Chen Division of Rheumatology
- Yi-Ming Chen Division of Rheumatology
- 謝祖怡 Division of Rheumatology
- 蔡肇基 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Ping-Han Tsai Division of Rheumatology
- Chang-Fu Kuo Division of Rheumatology
- Yao-Fan Fang Division of Rheumatology
- TianMing Zhan Division of Rheumatology
- 陳彥輔 Division of Rheumatology
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
- Po-Hao Huang 風濕免疫科
- 黃建中 風濕免疫科
- 吳柏樟 風濕免疫科
The Actual Total Number of Participants Enrolled
3 Study ended
Condition/Disease
Active Systemic Lupus Erythematosus
Objectives
The primary objective is to evaluate the efficacy of ustekinumab as measured by a reduction in disease activity for subjects with active SLE.
Test Drug
STELARA
Active Ingredient
Ustekinumab
Dosage Form
Syringe
Vial
Vial
Dosage
90mg
130mg
130mg
Endpoints
Primary Objective
The primary objective is to evaluate the efficacy of ustekinumab as measured by a reduction in
disease activity for subjects with active SLE.
Secondary Objectives
The secondary objectives are to evaluate:
• The safety and tolerability of ustekinumab in subjects with SLE.
• The effect of ustekinumab administration on health-related quality of life in subjects with SLE.
• The effects of ustekinumab on cutaneous manifestations of SLE.
• Pharmacokinetics and immunogenicity of ustekinumab in subjects with SLE.
The primary objective is to evaluate the efficacy of ustekinumab as measured by a reduction in
disease activity for subjects with active SLE.
Secondary Objectives
The secondary objectives are to evaluate:
• The safety and tolerability of ustekinumab in subjects with SLE.
• The effect of ustekinumab administration on health-related quality of life in subjects with SLE.
• The effects of ustekinumab on cutaneous manifestations of SLE.
• Pharmacokinetics and immunogenicity of ustekinumab in subjects with SLE.
Inclution Criteria
Inclusion Criteria Applicable to All Subjects
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1. Subject must be between 18 (or older as per local requirements) and 75 years of age,
inclusive, and weigh at least 35 kg.
2. Subjects must have documented medical history to meet SLICC classification criteria
for SLE for a minimum of 3 months prior to first dose (Table 2).
Subjects eligible for enrollment in this study must qualify as having SLE by meeting the
SLICC classification criteria for SLE23 based upon 1 or both of the following:
• Meeting 4 criteria with at least 1 clinical criterion and at least 1 immunologic
criterion, or
• A diagnosis of lupus nephritis with presence of at least 1 of the immunological
variables
To be eligible for study enrollment, subjects must have:
• At least 1 well-documented (subject file, referring physician letter, or laboratory
result) unequivocally positive, documented test for autoantibodies in medical history
including either of the following: ANA, and/or anti-dsDNA antibodies, and/or
anti-Smith antibodies (Section 9.1.2).
• At least 1 unequivocally positive autoantibody test including ANA and/or
anti-dsDNA antibodies and/or anti-Smith antibodies (Section 9.1.2) detected during
screening.
• At least 1 BILAG A and/or 2 BILAG B domain scores observed at screening and/or
at Week 0 prior to first administration of study agent.
4. Demonstrate active disease based on SLEDAI-2K score ≥6 observed during screening
and assessed approximately 2 to 6 weeks prior to randomization (Week 0). Must also
have SLEDAI-2K score ≥4 for clinical features (ie, SLEDAI excluding laboratory-based
items) at Week 0 prior to the first administration of study agent.
5. Data from the SLICC, SLEDAI and BILAG evaluations will be reviewed and
adjudicated by the Sponsor and/or the Sponsor-selected independent reviewer(s). For
subjects to receive their first administration of study agent, approval must be received
by the Sponsor and/or Sponsor-selected independent reviewers.
6. If using oral corticosteroids, subjects must be receiving this medication for at least
6 weeks and on a stable dose equivalent to an average dose of ≤20 mg/day of
prednisone for at least 4 weeks prior to the first administration of study agent. If
currently not using corticosteroids, must have not received oral corticosteroids for at
least 6 weeks prior to the first administration of study agent.
7. If using antimalarials (eg, chloroquine, hydroxychloroquine), subjects must be taken for
≥8 weeks and on stable dose for at least 6 weeks prior to the first administration of study
agent.
8. If using immunosuppressive drugs (mycophenolate mofetil [MMF]/mycophenolic acid
[MPA] ≤2 g/day, azathioprine/6-mercaptopurine (AZA /6 MP) ≤2 mg/kg/day and/or
MTX ≤25 mg/wk with concomitant folic acid [recommend ≥5 mg/wk]), subjects must
be receiving a stable dose for at least 6 weeks prior to the first administration of study
agent.
9. If receiving regular treatment with NSAIDs or other analgesics, subjects must be
receiving stable dosing for at least 2 weeks prior to first administration of study agent.
10. Before randomization, a woman must be either:
Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with
amenorrhea for at least 12 months); permanently sterilized (eg, tubal occlusion,
hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
Of childbearing potential and practicing a highly effective method of birth control
consistent with local regulations regarding the use of birth control methods for subjects
participating in clinical studies: eg, established use of oral, injected or implanted
hormonal methods of contraception; placement of an intrauterine device or intrauterine
system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or
occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner
should be the sole partner for that subject); true abstinence (when this is in line with the
preferred and usual lifestyle of the subject).
Note: If the childbearing potential changes after start of the study (eg, woman who is
not heterosexually active becomes active, premenarchal woman experiences menarche)
a woman must begin a highly effective method of birth control, as described above.
11. A woman of childbearing potential must have a negative serum pregnancy test
(β-human chorionic gonadotropin [β-hCG]) at screening, and a negative urine
pregnancy test at Week 0 before the first administration of study agent.
12. Women of childbearing potential must be willing to remain on a highly effective
method of birth control during the study and for 4 months after receiving the last study
agent. Also, women of childbearing potential must agree to not donate eggs (ova,
oocytes) for the purposes of assisted reproduction during the study and for 4 months
after receiving the last dose of study agent.
13. A man who is sexually active with a woman of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control eg, either condom with
spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm
or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men
must also not donate sperm during the study and for 4 months after receiving the last
dose of study agent.
14. Are considered eligible according to the following tuberculosis (TB) screening criteria:
a. Have no history of latent or active TB prior to screening. An exception is made
for subjects who have a history of latent TB and are currently receiving
treatment for latent TB, will initiate treatment for latent TB prior to first
administration of study agent, or have documentation of having completed
appropriate treatment for latent TB within 3 years prior to the first
administration of study agent. It is the responsibility of the investigator to verify
the adequacy of previous anti-tuberculous treatment and provide appropriate
documentation.
b. Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
c. Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent
TB prior to the first administration of study agent.
d. Within 6 weeks prior to the first administration of study agent, have a negative
QuantiFERON®-TB Gold test result (Attachment 2), or have a newly identified
positive QuantiFERON®-TB Gold test result in which active TB has been ruled
out and for which appropriate treatment for latent TB has been initiated prior to
the first administration of study agent. Within 6 weeks prior to the first
administration of study agent, a negative tuberculin skin test (Attachment 3), or
a newly identified positive tuberculin skin test in which active TB has been ruled
out and for which appropriate treatment for latent TB has been initiated prior to
the first administration of study agent, is additionally required if the
QuantiFERON®-TB Gold test is not approved/registered in that country or the
tuberculin skin test is mandated by local health authorities.
i. Subjects with persistently indeterminate QuantiFERON®-TB Gold test
results may be enrolled without treatment for latent TB, if active TB is
ruled out, their chest radiograph shows no abnormality suggestive of TB
(active or old, inactive TB), and the subject has no additional risk factors
for TB as determined by the investigator. This determination must be
promptly reported to the Sponsor’s medical monitor and recorded in the
subject's source documents and initialed by the investigator.
ii. The QuantiFERON®-TB Gold test and the tuberculin skin test are not
required at screening for subjects with a history of latent TB and ongoing
treatment for latent TB or documentation of having completed adequate
treatment as described above; Subjects with documentation of having
completed adequate treatment as described above are not required to
initiate additional treatment for latent TB.
e. Subjects who test positive for TB by a TB test other than QuantiFERON®-TB
Gold and TB skin test and who have no evidence of TB on chest radiograph will
in the context of this protocol be considered latent TB positive and be required
to undergo evaluation by a TB specialist and receive treatment for TB to be
eligible for this study.
f. Have a chest radiograph (both posterior-anterior and lateral views) taken within
3 months prior to the first administration of study agent and read by a qualified
radiologist or pulmonologist, with no evidence of current, active TB or old,
inactive TB.
15. Have laboratory test results within the following parameters at screening:
Hemoglobin ≥8.5 g/dL (SI: ≥85 g/L)
Lymphocytes ≥0.5 x 103
/µL (SI: ≥0.5 GI/L)
Neutrophils ≥1.0 x 103
/µL (SI: ≥1.0 GI/L)
Platelets ≥75 x 103
/µL (SI: ≥75 GI/L)
Serum creatinine ≤1.8 mg/dL (SI: ≤159 µmol/L)
White blood cells ≥2.0 x 103
/µL (SI: ≥2.0 GI/L)
The aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase
levels must be within 2 x upper limit of normal (ULN) range for the laboratory
conducting the test. For subjects within the range of 1.5 to 2 x ULN for transaminases,
the subject may be included only if the investigator judges the abnormalities or
deviations from normal to not be clinically significant or to be appropriate and
reasonable for the population under study. This determination must be promptly
reported to the Sponsor’s medical monitor and recorded in the subject's source
documents and initialed by the investigator.
Subjects with other marked disease-associated laboratory abnormalities may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant or to be appropriate and reasonable for the population under study.
This determination must be promptly reported to the Sponsor’s medical monitor and
recorded in the subject’s source documents and initialed by the investigator.
16. Subject must be willing and able to adhere to the prohibitions and restrictions specified
in this protocol.
17. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
18. Each subject must sign a separate informed consent form if he or she agrees to provide
an optional DNA sample for research (where local regulations permit). Refusal to give
consent for the optional DNA research sample does not exclude a subject from
participation in the study.
Each potential subject must satisfy all of the following criteria to be enrolled in the study.
1. Subject must be between 18 (or older as per local requirements) and 75 years of age,
inclusive, and weigh at least 35 kg.
2. Subjects must have documented medical history to meet SLICC classification criteria
for SLE for a minimum of 3 months prior to first dose (Table 2).
Subjects eligible for enrollment in this study must qualify as having SLE by meeting the
SLICC classification criteria for SLE23 based upon 1 or both of the following:
• Meeting 4 criteria with at least 1 clinical criterion and at least 1 immunologic
criterion, or
• A diagnosis of lupus nephritis with presence of at least 1 of the immunological
variables
To be eligible for study enrollment, subjects must have:
• At least 1 well-documented (subject file, referring physician letter, or laboratory
result) unequivocally positive, documented test for autoantibodies in medical history
including either of the following: ANA, and/or anti-dsDNA antibodies, and/or
anti-Smith antibodies (Section 9.1.2).
• At least 1 unequivocally positive autoantibody test including ANA and/or
anti-dsDNA antibodies and/or anti-Smith antibodies (Section 9.1.2) detected during
screening.
• At least 1 BILAG A and/or 2 BILAG B domain scores observed at screening and/or
at Week 0 prior to first administration of study agent.
4. Demonstrate active disease based on SLEDAI-2K score ≥6 observed during screening
and assessed approximately 2 to 6 weeks prior to randomization (Week 0). Must also
have SLEDAI-2K score ≥4 for clinical features (ie, SLEDAI excluding laboratory-based
items) at Week 0 prior to the first administration of study agent.
5. Data from the SLICC, SLEDAI and BILAG evaluations will be reviewed and
adjudicated by the Sponsor and/or the Sponsor-selected independent reviewer(s). For
subjects to receive their first administration of study agent, approval must be received
by the Sponsor and/or Sponsor-selected independent reviewers.
6. If using oral corticosteroids, subjects must be receiving this medication for at least
6 weeks and on a stable dose equivalent to an average dose of ≤20 mg/day of
prednisone for at least 4 weeks prior to the first administration of study agent. If
currently not using corticosteroids, must have not received oral corticosteroids for at
least 6 weeks prior to the first administration of study agent.
7. If using antimalarials (eg, chloroquine, hydroxychloroquine), subjects must be taken for
≥8 weeks and on stable dose for at least 6 weeks prior to the first administration of study
agent.
8. If using immunosuppressive drugs (mycophenolate mofetil [MMF]/mycophenolic acid
[MPA] ≤2 g/day, azathioprine/6-mercaptopurine (AZA /6 MP) ≤2 mg/kg/day and/or
MTX ≤25 mg/wk with concomitant folic acid [recommend ≥5 mg/wk]), subjects must
be receiving a stable dose for at least 6 weeks prior to the first administration of study
agent.
9. If receiving regular treatment with NSAIDs or other analgesics, subjects must be
receiving stable dosing for at least 2 weeks prior to first administration of study agent.
10. Before randomization, a woman must be either:
Not of childbearing potential: premenarchal; postmenopausal (>45 years of age with
amenorrhea for at least 12 months); permanently sterilized (eg, tubal occlusion,
hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
Of childbearing potential and practicing a highly effective method of birth control
consistent with local regulations regarding the use of birth control methods for subjects
participating in clinical studies: eg, established use of oral, injected or implanted
hormonal methods of contraception; placement of an intrauterine device or intrauterine
system; barrier methods: condom with spermicidal foam/gel/film/cream/suppository or
occlusive cap (diaphragm or cervical/vault caps) with spermicidal
foam/gel/film/cream/suppository; male partner sterilization (the vasectomized partner
should be the sole partner for that subject); true abstinence (when this is in line with the
preferred and usual lifestyle of the subject).
Note: If the childbearing potential changes after start of the study (eg, woman who is
not heterosexually active becomes active, premenarchal woman experiences menarche)
a woman must begin a highly effective method of birth control, as described above.
11. A woman of childbearing potential must have a negative serum pregnancy test
(β-human chorionic gonadotropin [β-hCG]) at screening, and a negative urine
pregnancy test at Week 0 before the first administration of study agent.
12. Women of childbearing potential must be willing to remain on a highly effective
method of birth control during the study and for 4 months after receiving the last study
agent. Also, women of childbearing potential must agree to not donate eggs (ova,
oocytes) for the purposes of assisted reproduction during the study and for 4 months
after receiving the last dose of study agent.
13. A man who is sexually active with a woman of childbearing potential and has not had a
vasectomy must agree to use a barrier method of birth control eg, either condom with
spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm
or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men
must also not donate sperm during the study and for 4 months after receiving the last
dose of study agent.
14. Are considered eligible according to the following tuberculosis (TB) screening criteria:
a. Have no history of latent or active TB prior to screening. An exception is made
for subjects who have a history of latent TB and are currently receiving
treatment for latent TB, will initiate treatment for latent TB prior to first
administration of study agent, or have documentation of having completed
appropriate treatment for latent TB within 3 years prior to the first
administration of study agent. It is the responsibility of the investigator to verify
the adequacy of previous anti-tuberculous treatment and provide appropriate
documentation.
b. Have no signs or symptoms suggestive of active TB upon medical history and/or
physical examination.
c. Have had no recent close contact with a person with active TB or, if there has
been such contact, will be referred to a physician specializing in TB to undergo
additional evaluation and, if warranted, receive appropriate treatment for latent
TB prior to the first administration of study agent.
d. Within 6 weeks prior to the first administration of study agent, have a negative
QuantiFERON®-TB Gold test result (Attachment 2), or have a newly identified
positive QuantiFERON®-TB Gold test result in which active TB has been ruled
out and for which appropriate treatment for latent TB has been initiated prior to
the first administration of study agent. Within 6 weeks prior to the first
administration of study agent, a negative tuberculin skin test (Attachment 3), or
a newly identified positive tuberculin skin test in which active TB has been ruled
out and for which appropriate treatment for latent TB has been initiated prior to
the first administration of study agent, is additionally required if the
QuantiFERON®-TB Gold test is not approved/registered in that country or the
tuberculin skin test is mandated by local health authorities.
i. Subjects with persistently indeterminate QuantiFERON®-TB Gold test
results may be enrolled without treatment for latent TB, if active TB is
ruled out, their chest radiograph shows no abnormality suggestive of TB
(active or old, inactive TB), and the subject has no additional risk factors
for TB as determined by the investigator. This determination must be
promptly reported to the Sponsor’s medical monitor and recorded in the
subject's source documents and initialed by the investigator.
ii. The QuantiFERON®-TB Gold test and the tuberculin skin test are not
required at screening for subjects with a history of latent TB and ongoing
treatment for latent TB or documentation of having completed adequate
treatment as described above; Subjects with documentation of having
completed adequate treatment as described above are not required to
initiate additional treatment for latent TB.
e. Subjects who test positive for TB by a TB test other than QuantiFERON®-TB
Gold and TB skin test and who have no evidence of TB on chest radiograph will
in the context of this protocol be considered latent TB positive and be required
to undergo evaluation by a TB specialist and receive treatment for TB to be
eligible for this study.
f. Have a chest radiograph (both posterior-anterior and lateral views) taken within
3 months prior to the first administration of study agent and read by a qualified
radiologist or pulmonologist, with no evidence of current, active TB or old,
inactive TB.
15. Have laboratory test results within the following parameters at screening:
Hemoglobin ≥8.5 g/dL (SI: ≥85 g/L)
Lymphocytes ≥0.5 x 103
/µL (SI: ≥0.5 GI/L)
Neutrophils ≥1.0 x 103
/µL (SI: ≥1.0 GI/L)
Platelets ≥75 x 103
/µL (SI: ≥75 GI/L)
Serum creatinine ≤1.8 mg/dL (SI: ≤159 µmol/L)
White blood cells ≥2.0 x 103
/µL (SI: ≥2.0 GI/L)
The aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase
levels must be within 2 x upper limit of normal (ULN) range for the laboratory
conducting the test. For subjects within the range of 1.5 to 2 x ULN for transaminases,
the subject may be included only if the investigator judges the abnormalities or
deviations from normal to not be clinically significant or to be appropriate and
reasonable for the population under study. This determination must be promptly
reported to the Sponsor’s medical monitor and recorded in the subject's source
documents and initialed by the investigator.
Subjects with other marked disease-associated laboratory abnormalities may be included
only if the investigator judges the abnormalities or deviations from normal to be not
clinically significant or to be appropriate and reasonable for the population under study.
This determination must be promptly reported to the Sponsor’s medical monitor and
recorded in the subject’s source documents and initialed by the investigator.
16. Subject must be willing and able to adhere to the prohibitions and restrictions specified
in this protocol.
17. Each subject must sign an informed consent form (ICF) indicating that he or she
understands the purpose of and procedures required for the study and are willing to
participate in the study.
18. Each subject must sign a separate informed consent form if he or she agrees to provide
an optional DNA sample for research (where local regulations permit). Refusal to give
consent for the optional DNA research sample does not exclude a subject from
participation in the study.
Exclusion Criteria
Any potential subject who meets any of the following criteria will be excluded from participating
in the study.
1. Have other inflammatory diseases that might confound the evaluations of efficacy,
including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
RA/lupus overlap, psoriasis or Lyme disease.
2. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the
study or within 4 months after receiving the last administration of study agent.
3. Have received systemic immunosuppressives other than those described in inclusion
criteria within the past 6 months prior to first administration of study agent
(Section 4.1). Corticosteroids are not included in this criterion; see other eligibility
criteria regarding corticosteroids.
4. Have received more than 1 previous B cell targeting therapy including belimumab or
epratuzamab within 6 months prior to first administration of the study agent or received
B-cell depleting therapy (eg, rituximab) within 12 months prior to first administration of
the study agent or have evidence of continued B-cell depletion following such therapy.
5. Have ever received ustekinumab.
6. Have received prior immunosuppressive biologic therapy for lupus not described in
Exclusion Criterion #4 including, but not limited to, tocilizumab, alefacept, efalizumab,
natalizumab, abatacept, anakinra, brodalumab, secukinumab, ixekizumab, less than
5 half-lives or 3 months, whichever is longer, prior to first administration of the study
agent.
7. Have a known hypersensitivity to human immunoglobulin (Ig) proteins (eg, intravenous
Ig).
8. Have used oral cyclophosphamide within 90 days or IV cyclophosphamide within
180 days of starting screening.
9. Have a history of active granulomatous infection, including histoplasmosis, or
coccidioidomycosis, prior to screening. Refer to inclusion criteria for information
regarding eligibility with a history of latent TB.
10. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
11. Have a chest radiograph within 3 months prior to the first administration of study agent
that shows an abnormality suggestive of a malignancy or current active infection,
including TB.
12. Have had a nontuberculous mycobacterial infection or opportunistic infection
(eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
13. Have received, or are expected to receive, any live virus or bacterial vaccination within
3 months before the first administration of study agent, during the study, or within
3 months after the last administration of study agent. For BCG vaccination criterion, see
Exclusion Criterion #10.
14. Have had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis,
or pyelonephritis), or have been hospitalized for an infection, or have been treated with
intravenous antibiotics for an infection within 2 months prior to first administration of
study agent. Less serious infections (eg, acute upper respiratory tract infection, simple
urinary tract infection) need not be considered exclusionary at the discretion of the
investigator.
15. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not
limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis,
recurrent urinary tract infection (eg, recurrent pyelonephritis), an open, draining, or
infected skin wound, or an ulcer.
16. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at screening.
17. Has a hepatitis B infection. Subjects must undergo screening for hepatitis B virus
(HBV) (Attachment 4). At a minimum, this includes testing for HBsAg (HBV surface
antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody
total).
18. Subjects who are seropositive for antibodies to hepatitis C virus (HCV), unless they
have 2 negative HCV RNA test results 6 months apart prior to screening and have a
third negative HCV RNA test result at screening.
19. Subjects having experienced a recent single dermatomal herpes zoster eruption within
the past 4 months are excluded. Those with multi-dermatomal herpes zoster or central
nervous system (CNS) zoster within the past 5 years are excluded.
20. Subjects with a history or suspected occurrence of drug-induced lupus.
21. Have urinary protein >4 g/day or protein/creatinine ratio >4.
22. Have inherited complement deficiency or combined variable immunodeficiency.
23. Have end-stage renal disease, or severe or rapidly progressive glomerulonephritis,
including severe, active lupus nephritis reported in recent biopsy and/or other
assessments such as active urinary sediment, rapidly increasing creatinine, or other
factors that suggest severe or rapidly progressing nephritis (see also limits on serum
creatinine in Inclusion Criterion #15).
24. Have severe CNS lupus including but not limited to seizures, psychosis, transverse
myelitis, CNS vasculitis and optic neuritis.
25. Have severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal,
endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current
signs and symptoms thereof.
26. Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
of unusual size or location, clinically significant splenomegaly, or history of monoclonal
gammopathy of undetermined significance.
27. Has known allergies, hypersensitivity, or intolerance to ustekinumab, its excipients or
latex (contained in the syringe needle cover, see Section 14.1) (refer to the ustekinumab
Investigator’s Brochure).
28. Are currently receiving venom immunotherapy (honeybee, wasp, yellow jacket, hornet,
or fire ant).
29. Has received an investigational drug (including investigational vaccines) within
5 half-lives or 3 months, whichever is longer, or used an invasive investigational
medical device within 3 months before the planned first dose of study drug, or is
currently enrolled in an interventional study.
30. Has any condition for which, in the opinion of the investigator and/or Sponsor,
participation would not be in the best interest of the subject (eg, compromise the
well-being) or that could prevent, limit, or confound the protocol-specified assessments
including a previous pattern of non-compliance with medical follow-up or being
deemed unlikely to be compliant with a study visit schedule.
31. Has had major surgery, (eg, requiring general anesthesia) within 1 month before
screening, or will not have fully recovered from surgery, or has major surgery
(eg, requiring general anesthesia) planned during the time the subject is expected to
participate in the study or within 1 month after the last dose of study drug
administration.
Note: subjects with planned minor surgical procedures to be conducted under local
anesthesia may participate
32. Have a transplanted organ (with the exception of a corneal transplant performed
>3 months prior to first administration of study agent).
33. Have or have had a substance abuse (drug or alcohol) problem within the previous
3 years.
34. Are unwilling or unable to undergo multiple venipunctures because of poor tolerability
or lack of easy venous access.
35. Subject is an employee of the investigator or study site, with direct involvement in the
proposed study or other studies under the direction of that investigator or study site, as
well as family members of the employees or the investigator.
in the study.
1. Have other inflammatory diseases that might confound the evaluations of efficacy,
including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA),
RA/lupus overlap, psoriasis or Lyme disease.
2. Are pregnant, nursing, or planning a pregnancy or fathering a child while enrolled in the
study or within 4 months after receiving the last administration of study agent.
3. Have received systemic immunosuppressives other than those described in inclusion
criteria within the past 6 months prior to first administration of study agent
(Section 4.1). Corticosteroids are not included in this criterion; see other eligibility
criteria regarding corticosteroids.
4. Have received more than 1 previous B cell targeting therapy including belimumab or
epratuzamab within 6 months prior to first administration of the study agent or received
B-cell depleting therapy (eg, rituximab) within 12 months prior to first administration of
the study agent or have evidence of continued B-cell depletion following such therapy.
5. Have ever received ustekinumab.
6. Have received prior immunosuppressive biologic therapy for lupus not described in
Exclusion Criterion #4 including, but not limited to, tocilizumab, alefacept, efalizumab,
natalizumab, abatacept, anakinra, brodalumab, secukinumab, ixekizumab, less than
5 half-lives or 3 months, whichever is longer, prior to first administration of the study
agent.
7. Have a known hypersensitivity to human immunoglobulin (Ig) proteins (eg, intravenous
Ig).
8. Have used oral cyclophosphamide within 90 days or IV cyclophosphamide within
180 days of starting screening.
9. Have a history of active granulomatous infection, including histoplasmosis, or
coccidioidomycosis, prior to screening. Refer to inclusion criteria for information
regarding eligibility with a history of latent TB.
10. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
11. Have a chest radiograph within 3 months prior to the first administration of study agent
that shows an abnormality suggestive of a malignancy or current active infection,
including TB.
12. Have had a nontuberculous mycobacterial infection or opportunistic infection
(eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening.
13. Have received, or are expected to receive, any live virus or bacterial vaccination within
3 months before the first administration of study agent, during the study, or within
3 months after the last administration of study agent. For BCG vaccination criterion, see
Exclusion Criterion #10.
14. Have had a serious infection (including but not limited to, hepatitis, pneumonia, sepsis,
or pyelonephritis), or have been hospitalized for an infection, or have been treated with
intravenous antibiotics for an infection within 2 months prior to first administration of
study agent. Less serious infections (eg, acute upper respiratory tract infection, simple
urinary tract infection) need not be considered exclusionary at the discretion of the
investigator.
15. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not
limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis,
recurrent urinary tract infection (eg, recurrent pyelonephritis), an open, draining, or
infected skin wound, or an ulcer.
16. Subject has a history of human immunodeficiency virus (HIV) antibody positive, or
tests positive for HIV at screening.
17. Has a hepatitis B infection. Subjects must undergo screening for hepatitis B virus
(HBV) (Attachment 4). At a minimum, this includes testing for HBsAg (HBV surface
antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody
total).
18. Subjects who are seropositive for antibodies to hepatitis C virus (HCV), unless they
have 2 negative HCV RNA test results 6 months apart prior to screening and have a
third negative HCV RNA test result at screening.
19. Subjects having experienced a recent single dermatomal herpes zoster eruption within
the past 4 months are excluded. Those with multi-dermatomal herpes zoster or central
nervous system (CNS) zoster within the past 5 years are excluded.
20. Subjects with a history or suspected occurrence of drug-induced lupus.
21. Have urinary protein >4 g/day or protein/creatinine ratio >4.
22. Have inherited complement deficiency or combined variable immunodeficiency.
23. Have end-stage renal disease, or severe or rapidly progressive glomerulonephritis,
including severe, active lupus nephritis reported in recent biopsy and/or other
assessments such as active urinary sediment, rapidly increasing creatinine, or other
factors that suggest severe or rapidly progressing nephritis (see also limits on serum
creatinine in Inclusion Criterion #15).
24. Have severe CNS lupus including but not limited to seizures, psychosis, transverse
myelitis, CNS vasculitis and optic neuritis.
25. Have severe, progressive, or uncontrolled hepatic, hematological, gastrointestinal,
endocrine, pulmonary, cardiac, neurologic/ cerebral, or psychiatric disease, or current
signs and symptoms thereof.
26. Have a known history of lymphoproliferative disease, including lymphoma, or signs and
symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy
of unusual size or location, clinically significant splenomegaly, or history of monoclonal
gammopathy of undetermined significance.
27. Has known allergies, hypersensitivity, or intolerance to ustekinumab, its excipients or
latex (contained in the syringe needle cover, see Section 14.1) (refer to the ustekinumab
Investigator’s Brochure).
28. Are currently receiving venom immunotherapy (honeybee, wasp, yellow jacket, hornet,
or fire ant).
29. Has received an investigational drug (including investigational vaccines) within
5 half-lives or 3 months, whichever is longer, or used an invasive investigational
medical device within 3 months before the planned first dose of study drug, or is
currently enrolled in an interventional study.
30. Has any condition for which, in the opinion of the investigator and/or Sponsor,
participation would not be in the best interest of the subject (eg, compromise the
well-being) or that could prevent, limit, or confound the protocol-specified assessments
including a previous pattern of non-compliance with medical follow-up or being
deemed unlikely to be compliant with a study visit schedule.
31. Has had major surgery, (eg, requiring general anesthesia) within 1 month before
screening, or will not have fully recovered from surgery, or has major surgery
(eg, requiring general anesthesia) planned during the time the subject is expected to
participate in the study or within 1 month after the last dose of study drug
administration.
Note: subjects with planned minor surgical procedures to be conducted under local
anesthesia may participate
32. Have a transplanted organ (with the exception of a corneal transplant performed
>3 months prior to first administration of study agent).
33. Have or have had a substance abuse (drug or alcohol) problem within the previous
3 years.
34. Are unwilling or unable to undergo multiple venipunctures because of poor tolerability
or lack of easy venous access.
35. Subject is an employee of the investigator or study site, with direct involvement in the
proposed study or other studies under the direction of that investigator or study site, as
well as family members of the employees or the investigator.
The Estimated Number of Participants
-
Taiwan
14 participants
-
Global
100 participants
