Clinical Trials List
Protocol NumberI6T-MC-AMAK
NCT Number(ClinicalTrials.gov Identfier)NCT03482011
Completed
2018-04-24 - 2020-01-16
Phase III
Terminated7
ICD-10L40.9
Psoriasis, unspecified
ICD-10L40.0
Psoriasis vulgaris
ICD-9696.0
Psoriatic arthropathy
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Withdrawal Maintenance Dosing Period to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-1
-
Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
-
Sponsor
Eli Lilly and Company
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chao-Kai Hsu Division of Dermatology
- Tak-Wah Wong Division of Dermatology
- Wei-Ting Tu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 黃瑞雲 醫師 Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chia-Lun Chou Division of Dermatology
The Actual Total Number of Participants Enrolled
4 Stop recruiting
Audit
CRO
Linkou Chang Gung Medical Foundation
Taiwan National PI
黃毓惠
Co-Principal Investigator
- Ya-Ching Chang Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
16 Stop recruiting
Audit
None
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Condition/Disease
Moderate-to-Severe Plaque Psoriasis
Objectives
Primary
To assess whether mirikizumab induction dosing is
superior to placebo in the treatment of patients with
respect to high levels of clinical response
Major Secondary
-To assess whether mirikizumab induction dosing is
superior to placebo with respect to an early, clinically
meaningful response
-To assess whether the mirikizumab induction dosing
is superior to placebo with respect to clinically
meaningful response and the highest levels of clinical
response
-To assess whether mirikizumab induction dosing is
superior to placebo with respect to body surface area
(BSA) affected by psoriasis
-To assess whether mirikizumab induction dosing is
superior to placebo with respect to patient-reported
outcomes
-To assess whether 250 mg mirikizumab Q8W and
125 mg mirikizumab Q8W maintenance dosing is
superior to placebo with respect to maintenance of a
high level of clinical response
Test Drug
Mirikizumab
Active Ingredient
Mirikizumab
Dosage Form
pre-filled syringe
Dosage
125mg
Endpoints
At Week 16:
Proportion of patients with an sPGA (0,1) with at
least a 2-point improvement from baseline
Proportion of patients achieving a ≥90%
improvement in PASI from baseline (PASI 90)
Proportion of patients with an sPGA (0,1) with at
least a 2-point improvement from baseline
Proportion of patients achieving a ≥90%
improvement in PASI from baseline (PASI 90)
Inclution Criteria
Inclusion Criteria
Patients are eligible to be included in the study only if they meet all of the following criteria
within the screening period, which is ≤28 days prior to the start of study treatment unless
otherwise defined:
Type of Patient and Disease Characteristics
[1] Present with chronic plaque psoriasis based on the investigator-confirmed
diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline,
and meet the following criteria:
A. Plaque psoriasis involving ≥10% body surface area (BSA) and absolute
PASI score ≥12 in affected skin at screening (Visit 1) and baseline
(Visit 2), and
B. sPGA score of ≥3 at screening (Visit 1) and baseline (Visit 2).
[2] Candidate for systemic therapy and/or phototherapy.
Patient Characteristics
[3a] Male patients:
No male contraception required except in compliance with specific local
government study requirement.
[3b] Female patients:
Women not of childbearing potential may participate and include those who are:
A. Infertile due to surgical sterilization (hysterectomy,
bilateral oophorectomy, or tubal ligation), congenital
anomaly such as mullerian agenesis,
OR
B. Postmenopausal, defined as:
i. A woman at least 50 years of age with an intact
uterus, not on hormone therapy, who has had either:
a. Cessation of menses for at least 1 year,
OR
b. At least 6 months of spontaneous amenorrhea
with a follicle stimulating hormone
>40 mIU/mL,
OR
ii. A woman 55 years or older not on hormone therapy,
who has had at least 6 months of spontaneous
amenorrhea,
OR
iii. A woman at least 55 years of age with a diagnosis of
menopause prior to starting hormone replacement
therapy.
Women of childbearing potential:
A. Must test negative for pregnancy prior to initiation of treatment as
indicated by a negative serum pregnancy test at the screening visit
followed by a negative urine pregnancy test within 24 hours prior to
exposure.
B. Must agree to either remain abstinent, if complete abstinence is their
preferred and usual lifestyle, or remain in same-sex relationships, if part
of their preferred and usual lifestyle, without sexual relationships with
males. Periodic abstinence (for example, calendar, ovulation,
symptothermal, post-ovulation methods), declaration of abstinence just
for the duration of a trial, and withdrawal are not acceptable methods of
contraception.
OR
Must use 2 effective methods of contraception for the entirety of the
study. Abstinence or contraception must continue for 12 weeks following
completion of investigational product administration.
i. Two effective methods of contraception (such as male or female
condoms with spermicide, diaphragms with spermicide or cervical
sponges) will be used. The patient may choose to use a doublebarrier method of contraception. Barrier protection methods without
concomitant use of a spermicide are not a reliable or acceptable
method. Thus, each barrier method must include use of a 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.
ii. Of note, one of the two methods of contraception may be a highly
effective (less than 1% failure rate) method of contraception (such as
combination oral contraceptives, implanted contraceptives or
intrauterine devices).
[4] Are at least 18 years of age at the time of screening.
[5] Have adequate organ function, including:
A. Hematologic:
i. Absolute neutrophil count 1.5 x 109/L (1.5 x 103/µL or
1.5 GI/L),
ii. Platelet count 100 x 109/L (100 x 103/µL or 100 GI/L),
iii. Hemoglobin level 10.0 g/dL (100 g/L),
iv. Lymphocyte count >500 cells/µL (>0.50 x 103/µL or >0.50 GI/L),
v. Total white blood cell count 3.0 x 109/L (3.0 x 103/µL or
3.0 GI/L).
B. Chemistry:
i. Serum creatinine ≤2x the upper limit of normal (ULN),
ii. Alanine aminotransferase (ALT) ≤2x ULN,
iii. Aspartate aminotransferase (AST) levels ≤2x ULN,
iv. Total bilirubin level <1.5x ULN (patients with Gilbert’s syndrome
must have serum direct bilirubin <1.5 mg/dL or <25.7 µmol/L),
v. Alkaline phosphatase (ALP) <1.5x ULN.
(Note: The tests for AST and ALT may be repeated once within a week
if the initial response exceeds this limit, and the repeat value may be
accepted if it meets this criterion. Other laboratory tests should not be
repeated unless there is a technical error or clinical reasons to believe a
result may be erroneous, and requires approval by the Eli Lilly and
Company [Lilly]-designated medical monitor.)
[6] Are reliable and willing to make themselves available for the duration of the
study and are able and willing to follow study procedures, including use of
electronic device for recording of data.
Informed Consent
[7] Have given written informed consent as a legal adult according to local
regulations.
Patients are eligible to be included in the study only if they meet all of the following criteria
within the screening period, which is ≤28 days prior to the start of study treatment unless
otherwise defined:
Type of Patient and Disease Characteristics
[1] Present with chronic plaque psoriasis based on the investigator-confirmed
diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline,
and meet the following criteria:
A. Plaque psoriasis involving ≥10% body surface area (BSA) and absolute
PASI score ≥12 in affected skin at screening (Visit 1) and baseline
(Visit 2), and
B. sPGA score of ≥3 at screening (Visit 1) and baseline (Visit 2).
[2] Candidate for systemic therapy and/or phototherapy.
Patient Characteristics
[3a] Male patients:
No male contraception required except in compliance with specific local
government study requirement.
[3b] Female patients:
Women not of childbearing potential may participate and include those who are:
A. Infertile due to surgical sterilization (hysterectomy,
bilateral oophorectomy, or tubal ligation), congenital
anomaly such as mullerian agenesis,
OR
B. Postmenopausal, defined as:
i. A woman at least 50 years of age with an intact
uterus, not on hormone therapy, who has had either:
a. Cessation of menses for at least 1 year,
OR
b. At least 6 months of spontaneous amenorrhea
with a follicle stimulating hormone
>40 mIU/mL,
OR
ii. A woman 55 years or older not on hormone therapy,
who has had at least 6 months of spontaneous
amenorrhea,
OR
iii. A woman at least 55 years of age with a diagnosis of
menopause prior to starting hormone replacement
therapy.
Women of childbearing potential:
A. Must test negative for pregnancy prior to initiation of treatment as
indicated by a negative serum pregnancy test at the screening visit
followed by a negative urine pregnancy test within 24 hours prior to
exposure.
B. Must agree to either remain abstinent, if complete abstinence is their
preferred and usual lifestyle, or remain in same-sex relationships, if part
of their preferred and usual lifestyle, without sexual relationships with
males. Periodic abstinence (for example, calendar, ovulation,
symptothermal, post-ovulation methods), declaration of abstinence just
for the duration of a trial, and withdrawal are not acceptable methods of
contraception.
OR
Must use 2 effective methods of contraception for the entirety of the
study. Abstinence or contraception must continue for 12 weeks following
completion of investigational product administration.
i. Two effective methods of contraception (such as male or female
condoms with spermicide, diaphragms with spermicide or cervical
sponges) will be used. The patient may choose to use a doublebarrier method of contraception. Barrier protection methods without
concomitant use of a spermicide are not a reliable or acceptable
method. Thus, each barrier method must include use of a 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.
ii. Of note, one of the two methods of contraception may be a highly
effective (less than 1% failure rate) method of contraception (such as
combination oral contraceptives, implanted contraceptives or
intrauterine devices).
[4] Are at least 18 years of age at the time of screening.
[5] Have adequate organ function, including:
A. Hematologic:
i. Absolute neutrophil count 1.5 x 109/L (1.5 x 103/µL or
1.5 GI/L),
ii. Platelet count 100 x 109/L (100 x 103/µL or 100 GI/L),
iii. Hemoglobin level 10.0 g/dL (100 g/L),
iv. Lymphocyte count >500 cells/µL (>0.50 x 103/µL or >0.50 GI/L),
v. Total white blood cell count 3.0 x 109/L (3.0 x 103/µL or
3.0 GI/L).
B. Chemistry:
i. Serum creatinine ≤2x the upper limit of normal (ULN),
ii. Alanine aminotransferase (ALT) ≤2x ULN,
iii. Aspartate aminotransferase (AST) levels ≤2x ULN,
iv. Total bilirubin level <1.5x ULN (patients with Gilbert’s syndrome
must have serum direct bilirubin <1.5 mg/dL or <25.7 µmol/L),
v. Alkaline phosphatase (ALP) <1.5x ULN.
(Note: The tests for AST and ALT may be repeated once within a week
if the initial response exceeds this limit, and the repeat value may be
accepted if it meets this criterion. Other laboratory tests should not be
repeated unless there is a technical error or clinical reasons to believe a
result may be erroneous, and requires approval by the Eli Lilly and
Company [Lilly]-designated medical monitor.)
[6] Are reliable and willing to make themselves available for the duration of the
study and are able and willing to follow study procedures, including use of
electronic device for recording of data.
Informed Consent
[7] Have given written informed consent as a legal adult according to local
regulations.
Exclusion Criteria
Exclusion Criteria
Patients will be excluded from study enrollment if they meet any of the following criteria at
screening, unless otherwise specified:
Medical Conditions
[8] Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the
opinion of the investigator, increases the risks associated with participating in
the study.
[9] Have an unstable or uncontrolled illness, including but not limited to a
cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, or neurologic disease or abnormal laboratory values at
screening, that in the opinion of the investigator, would potentially affect
patient safety within the study or of interfering with the interpretation of data.
[10] Presence of significant uncontrolled neuropsychiatric disorder or judged
at-risk of suicide in the opinion of the investigator;
OR
marked “yes” to Columbia-Suicidality Severity Rating Scale (C-SSRS)
question 4 or 5 on ideation at Visit 1, or prior to dosing at Visit 2;
OR
“yes” to C-SSRS suicide behaviors question 1 month prior to Visit 1, or prior
to dosing at Visit 2;
OR
Has a history of suicide attempt within 1 month prior to screening.
[11] Have human immunodeficiency virus (HIV)/acquired immune deficiency
syndrome (AIDS) or test positive human HIV antibodies at screening.
[12] Have hepatitis C or test positive for hepatitis C virus (HCV) at screening,
defined as: positive result for hepatitis C antibody and positive confirmatory
HCV ribonucleic acid (RNA) test (see Section 9.4.5.5). Patients in sustained
virologic response after HCV therapy, and patients who have spontaneously
cleared HCV infection (see Section 9.4.5.5), can be included in this study.
[13] Have hepatitis B or test positive for hepatitis B virus (HBV) at screening,
defined as:
A. Positive for hepatitis B surface antigen (HBsAg+),
OR
B. Positive for hepatitis B core antibody (HBcAb+) in conjunction with positive
confirmatory HBV deoxyribonucleic acid (DNA) test
OR
C. Positive HBV DNA test, regardless of anti-hepatitis B surface antibody
(HBsAb) status.
[14] Are women who are breastfeeding or plan to breastfeed during study.
[15] Have donated blood of >500 mL within 14 days prior to baseline.
[16] Have had serious, opportunistic (see Section 9.2.3 and Appendix 4), or
chronic/recurring infection within 3 months prior to screening. Examples
include, but are not limited to, infections requiring IV antibiotics,
hospitalization, or prolonged treatment.
[17] Have received a systemic (including oral) anti-infective agent for an infection
within 28 days of baseline (see Section 6.4 for information on rescreening).
[18] Have had, according to the investigator, clinically significant herpes zoster
within 3 months of screening.
[19] Have evidence of active or latent tuberculosis (TB) (refer to Section 9.4.5.2
for details on full TB exclusion criteria and Section 6.4 for information on
rescreening).
[20] Have received a Bacillus Calmette-Guerin (BCG) vaccination within
12 months or received live vaccine(s) (including attenuated live vaccines)
within 12 weeks of baseline or intend to receive either during the study.
[21] Have history of hypersensitivity events to any components of the mirikizumab
product formulation.
[22] Have active or history of lymphoma, leukemia, or any
malignancy. Exceptions: the following conditions are not
exclusionary: successfully treated basal cell skin carcinoma, squamous cell
skin carcinoma, or cervical carcinoma in situ, with no evidence of recurrence
or metastatic disease within the 5 years prior to baseline.
[23] Have any other skin conditions (excluding plaque psoriasis) that would affect
interpretation of the results (including, but not limited to, scleroderma,
eczema, drug-induced psoriasis, guttate psoriasis, pustular psoriasis,
parapsoriasis, or cutaneous manifestations of other autoimmune diseases such
as systemic lupus erythematosus).
Prior/Concomitant Therapy
[24] Have received systemic nonbiologic therapy (including, but not limited to,
oral psoralen and ultraviolet A [PUVA] light therapy; cyclosporine;
corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib;
mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus;
azathioprine; lefludimide; fumaric acid derivatives; or 1,25-dihydroxyvitamin
D3 and analogues) or phototherapy (including either oral and topical PUVA
light therapy, ultraviolet B, excimer laser, or self-treatment with tanning beds
or therapeutic sunbathing) within 28 days prior to baseline.
[25] Have received topical treatment (including, but not limited to, corticosteroids
[mild or least potent topical steroids will be permitted for use limited to the
face, axilla, or genitalia], crisaborole, anthralin, calcipotriene, topical
vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus,
emollients and other nonprescription topical products containing urea,
>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos [for
example, those that contain >3% salicylic acid, corticosteroids, coal tar, or
vitamin D3 analogues]) within 14 days prior to baseline.
[26] Have received anti-TNF targeting biologics within 8 weeks prior to baseline,
or anti-IL-17 targeting biologics within 12 weeks prior to baseline.
[27] Have previous exposure to any biologic therapy targeting IL-12/23 (p40
subunit), or IL-23 (p19 subunit), either marketed or investigational.
[28] Are unable or unwilling to avoid excessive sun exposure or use of tanning
booths for at least 4 weeks prior to baseline and during the study.
Prior/Concurrent Clinical Trial Experience
[29] 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.
[30] Have participated, within the last 30 days, in a clinical study involving an
investigational product.
If the previous investigational product has a long half-life, 3 months or
5 half-lives (whichever is longer) should have passed prior to screening.
[31] Have previously completed or withdrawn from this study or any other study
investigating mirikizumab.
Other Exclusions
[32] Are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
[33] Are Lilly employees or employees of third-party organization involved with
the study who require exclusion of their employees.
[34] Are unsuitable for inclusion in the study in the opinion of the investigator or
Sponsor for any reason that may compromise the patient’s safety or confound
data interpretation.
Patients will be excluded from study enrollment if they meet any of the following criteria at
screening, unless otherwise specified:
Medical Conditions
[8] Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the
opinion of the investigator, increases the risks associated with participating in
the study.
[9] Have an unstable or uncontrolled illness, including but not limited to a
cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, or neurologic disease or abnormal laboratory values at
screening, that in the opinion of the investigator, would potentially affect
patient safety within the study or of interfering with the interpretation of data.
[10] Presence of significant uncontrolled neuropsychiatric disorder or judged
at-risk of suicide in the opinion of the investigator;
OR
marked “yes” to Columbia-Suicidality Severity Rating Scale (C-SSRS)
question 4 or 5 on ideation at Visit 1, or prior to dosing at Visit 2;
OR
“yes” to C-SSRS suicide behaviors question 1 month prior to Visit 1, or prior
to dosing at Visit 2;
OR
Has a history of suicide attempt within 1 month prior to screening.
[11] Have human immunodeficiency virus (HIV)/acquired immune deficiency
syndrome (AIDS) or test positive human HIV antibodies at screening.
[12] Have hepatitis C or test positive for hepatitis C virus (HCV) at screening,
defined as: positive result for hepatitis C antibody and positive confirmatory
HCV ribonucleic acid (RNA) test (see Section 9.4.5.5). Patients in sustained
virologic response after HCV therapy, and patients who have spontaneously
cleared HCV infection (see Section 9.4.5.5), can be included in this study.
[13] Have hepatitis B or test positive for hepatitis B virus (HBV) at screening,
defined as:
A. Positive for hepatitis B surface antigen (HBsAg+),
OR
B. Positive for hepatitis B core antibody (HBcAb+) in conjunction with positive
confirmatory HBV deoxyribonucleic acid (DNA) test
OR
C. Positive HBV DNA test, regardless of anti-hepatitis B surface antibody
(HBsAb) status.
[14] Are women who are breastfeeding or plan to breastfeed during study.
[15] Have donated blood of >500 mL within 14 days prior to baseline.
[16] Have had serious, opportunistic (see Section 9.2.3 and Appendix 4), or
chronic/recurring infection within 3 months prior to screening. Examples
include, but are not limited to, infections requiring IV antibiotics,
hospitalization, or prolonged treatment.
[17] Have received a systemic (including oral) anti-infective agent for an infection
within 28 days of baseline (see Section 6.4 for information on rescreening).
[18] Have had, according to the investigator, clinically significant herpes zoster
within 3 months of screening.
[19] Have evidence of active or latent tuberculosis (TB) (refer to Section 9.4.5.2
for details on full TB exclusion criteria and Section 6.4 for information on
rescreening).
[20] Have received a Bacillus Calmette-Guerin (BCG) vaccination within
12 months or received live vaccine(s) (including attenuated live vaccines)
within 12 weeks of baseline or intend to receive either during the study.
[21] Have history of hypersensitivity events to any components of the mirikizumab
product formulation.
[22] Have active or history of lymphoma, leukemia, or any
malignancy. Exceptions: the following conditions are not
exclusionary: successfully treated basal cell skin carcinoma, squamous cell
skin carcinoma, or cervical carcinoma in situ, with no evidence of recurrence
or metastatic disease within the 5 years prior to baseline.
[23] Have any other skin conditions (excluding plaque psoriasis) that would affect
interpretation of the results (including, but not limited to, scleroderma,
eczema, drug-induced psoriasis, guttate psoriasis, pustular psoriasis,
parapsoriasis, or cutaneous manifestations of other autoimmune diseases such
as systemic lupus erythematosus).
Prior/Concomitant Therapy
[24] Have received systemic nonbiologic therapy (including, but not limited to,
oral psoralen and ultraviolet A [PUVA] light therapy; cyclosporine;
corticosteroids; methotrexate; oral retinoids; apremilast; tofacitinib;
mycophenolate mofetil; thioguanine; hydroxyurea; sirolimus; tacrolimus;
azathioprine; lefludimide; fumaric acid derivatives; or 1,25-dihydroxyvitamin
D3 and analogues) or phototherapy (including either oral and topical PUVA
light therapy, ultraviolet B, excimer laser, or self-treatment with tanning beds
or therapeutic sunbathing) within 28 days prior to baseline.
[25] Have received topical treatment (including, but not limited to, corticosteroids
[mild or least potent topical steroids will be permitted for use limited to the
face, axilla, or genitalia], crisaborole, anthralin, calcipotriene, topical
vitamin D derivatives, retinoids, tazarotene, pimecrolimus, tacrolimus,
emollients and other nonprescription topical products containing urea,
>3% salicylic acid, alpha- or beta-hydroxyl acids, or medicated shampoos [for
example, those that contain >3% salicylic acid, corticosteroids, coal tar, or
vitamin D3 analogues]) within 14 days prior to baseline.
[26] Have received anti-TNF targeting biologics within 8 weeks prior to baseline,
or anti-IL-17 targeting biologics within 12 weeks prior to baseline.
[27] Have previous exposure to any biologic therapy targeting IL-12/23 (p40
subunit), or IL-23 (p19 subunit), either marketed or investigational.
[28] Are unable or unwilling to avoid excessive sun exposure or use of tanning
booths for at least 4 weeks prior to baseline and during the study.
Prior/Concurrent Clinical Trial Experience
[29] 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.
[30] Have participated, within the last 30 days, in a clinical study involving an
investigational product.
If the previous investigational product has a long half-life, 3 months or
5 half-lives (whichever is longer) should have passed prior to screening.
[31] Have previously completed or withdrawn from this study or any other study
investigating mirikizumab.
Other Exclusions
[32] Are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
[33] Are Lilly employees or employees of third-party organization involved with
the study who require exclusion of their employees.
[34] Are unsuitable for inclusion in the study in the opinion of the investigator or
Sponsor for any reason that may compromise the patient’s safety or confound
data interpretation.
The Estimated Number of Participants
-
Taiwan
72 participants
-
Global
530 participants
