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Protocol NumberI4V-MC-JAIM
NCT Number(ClinicalTrials.gov Identfier)NCT03843125

2020-06-01 - 2022-01-31

Phase III

Recruiting9

ICD-10M32.0

Drug-induced systemic lupus erythematosus

ICD-10M32.10

Systemic lupus erythematosus, organ or system involvement unspecified

ICD-10M32.11

Endocarditis in systemic lupus erythematosus

ICD-10M32.12

Pericarditis in systemic lupus erythematosus

ICD-10M32.13

Lung involvement in systemic lupus erythematosus

ICD-10M32.14

Glomerular disease in systemic lupus erythematosus

ICD-10M32.15

Tubulo-interstitial nephropathy in systemic lupus erythematosus

ICD-10M32.19

Other organ or system involvement in systemic lupus erythematosus

ICD-10M32.8

Other forms of systemic lupus erythematosus

ICD-10M32.9

Systemic lupus erythematosus, unspecified

ICD-9710.0

Systemic lupus erythematosus

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

  • Trial Applicant

    PPD DEVELOPMENT (HK) LIMITED

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator 賴寧生 Division of Rheumatology
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yao-Fan Fang Division of Rheumatology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEN-NAN HUANG Division of Rheumatology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang 風濕免疫科
Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 邱文燦 Division of Rheumatology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宏安 Division of Rheumatology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Joung-Liang Lan 風濕免疫科
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 曾瑞成 Division of Rheumatology
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator SONG-CHOU HSIEH 風濕免疫科
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Systemic Lupus Erythematosus (SLE)

Objectives

Primary To evaluate the long-term safety and tolerability of baricitinib in patients with SLE. Secondary  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD and background standard-of-care therapy on SLE disease activity.  To evaluate the long-term corticosteroid sparing effect of baricitinib 4-mg or 2-mg QD.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on SLE flares.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on mucocutaneous manifestations of SLE.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on musculoskeletal manifestations of SLE.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on individual organ system disease activity.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on damage.  To evaluate the long-term effect of baricitinib 4-mg or 2-mg QD on patient-reported outcomes (PROs).

Test Drug

Baricitinib

Active Ingredient

Baricitinib

Dosage Form

tablet
tablet

Dosage

2mg/tablet
4mg/tablet

Endpoints

Primary Outcome Measures :
Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 156 ]
Percentage of participants with TEAEs

Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline through Week 156 ]
Percentage of Participants with AESIs

Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Baseline through Week 156 ]
Percentage of participants with SAEs

Percentage of Participants with Temporary Investigational Product Interruptions [ Time Frame: Baseline through Week 156 ]
Percentage of participants with temporary investigational product interruptions

Percentage of Participants with Permanent Investigational Product Discontinuations [ Time Frame: Baseline through Week 156 ]
Percentage of participants with permanent investigational product discontinuations


Secondary Outcome Measures :
Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response [ Time Frame: Week 156 ]
Percentage of participants achieving SRI-4 response

Percentage of Participants Achieving a Lupus Low Disease Activity State (LLDAS) [ Time Frame: Week 156 ]
Percentage of participants achieving a LLDAS

Change from Baseline in Prednisone Dose [ Time Frame: Baseline, Week 156 ]
Change from baseline in prednisone dose

Annualized Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Flare Index Flare Rate [ Time Frame: Baseline through Week 156 ]
Annualized SELENA-SLEDAI flare index flare rate

Percentage of Participants with Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Total Activity Score ≥10 at Baseline with ≥50% Reduction in CLASI Total Activity Score [ Time Frame: Week 156 ]
Percentage of participants with CLASI total activity score ≥10 at baseline with ≥50% reduction in CLASI total activity score

Change from Baseline in Tender Joint Count [ Time Frame: Baseline, Week 156 ]
Change from baseline in tender joint count

Change from Baseline in Swollen Joint Count [ Time Frame: Baseline, Week 156 ]
Change from baseline in swollen joint count

Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Total Score [ Time Frame: Baseline, Week 156 ]
Change from baseline in SLICC/ACR damage index total score

Change from Baseline in Worst Pain Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 156 ]
Change from baseline in worst pain NRS

Inclution Criteria

Type of Patient and Disease Characteristics
[1] Have completed the final treatment study visit of an originating study, such as
Study JAHZ or Study JAIA.

Patient Characteristics
[2] Male or nonpregnant, nonbreastfeeding female patient
a. Patients of child-bearing potential who are abstinent (if this is complete
abstinence, as their preferred and usual lifestyle) or in a same-sex relationship
(as part of their preferred and usual lifestyle) must agree to either remain
abstinent or stay in a same-sex relationship without sexual relationships with
the opposite sex.
b. Total abstinence is defined as refraining from intercourse during the entirety
of the study and for at least 1 week following the last dose of investigational
product. Periodic abstinence, such as calendar, ovulation, symptothermal,
post-ovulation methods, and withdrawal, are not acceptable methods of
contraception.
c. Otherwise, patients of childbearing potential together with their partners must
agree to use 2 effective methods of contraception, where at least 1 form is
highly effective, for the entirety of the study and for at least 1 week following
the last dose of investigational product.
d. The following contraception methods are considered acceptable (the patient
should choose 2, and 1 must be highly effective [defined as less than 1%
failure rate per year when used consistently and correctly]):
 Highly effective birth control methods:
 Combined (estrogen and progestogen containing) hormonal
contraception associated with inhibition of ovulation: oral,
intravaginal, or transdermal
 Progestogen-only containing hormonal contraception associated
with inhibition of ovulation: oral, intravaginal, or transdermal
 Intrauterine device (IUD)/intrauterine hormone-releasing system
(IUS)
 Vasectomized male (with appropriate post-vasectomy
documentation of the absence of sperm in the ejaculate).
 Effective birth control methods:
 Male or female condom with spermicide. It should be noted that
the use of male and female condoms as a double barrier method is
not considered acceptable due to the high failure rate when these
methods are combined.
 Diaphragm with spermicide
 Cervical sponge
 Cervical cap with spermicide
Note: When local guidelines concerning highly effective or effective
methods of birth control differ from the above, the local guidelines must
be followed.
Patients of non‒child-bearing potential are not required to use birth control and
they are defined as:
 Women who are infertile due to surgical sterilization (hysterectomy,
bilateral oophorectomy, or tubal ligation)
 Post-menopausal – defined either as
 A woman at least 50 years of age with an intact uterus, not on
hormone therapy, who has had either
 Cessation of menses for at least 1 year
 At least 6 months of spontaneous amenorrhea with folliclestimulating hormone >40 mIU/mL
 Women aged 55 years or older who are not on hormone therapy,
and who have had at least 6 months of spontaneous amenorrhea
 Women aged 55 years or older who have a diagnosis of menopause

Informed Consent
[3] Must read and understand the informed consent approved by Eli Lilly and
Company (Lilly), or its designee, and the institutional review board (IRB)/ethics
review board (ERB) governing the site, and provide written informed consent.

Exclusion Criteria

Medical Conditions
[1] Have significant uncontrolled cerebro-cardiovascular (for example, myocardial
infarction, unstable angina, unstable arterial hypertension, severe heart failure, or
cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, neuropsychiatric disorders, or abnormal laboratory values that, in
the opinion of the investigator, pose an unacceptable risk to the patient if
investigational product continues to be administered.
[2] Have a known hypersensitivity to baricitinib or any component of this
investigational product.
[3] Had investigational product permanently discontinued at any time during a
previous baricitinib study.
[4] Had temporary investigational product interruption at the final study visit of a
previous baricitinib study and, in the opinion of the investigator, this poses an
unacceptable risk for the patient’s participation in the study.
[5] Have any other condition that, in the opinion of the investigator, renders the
patient unable to understand the nature, scope, and possible consequences of the
study or precludes the patient from following and completing the protocol.
[6] Are currently enrolled in any other clinical study involving an investigational
product or any other type of medical research, judged not to be scientifically or
medically compatible with this study.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    1100 participants

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