Clinical Trials List
Protocol NumberI6T-MC-AMAH
NCT Number(ClinicalTrials.gov Identfier)NCT03556202
Completed
2019-06-15 - 2025-05-31
Phase III
Terminated7
ICD-10L40.50
Arthropathic psoriasis, unspecified
ICD-10L40.51
Distal interphalangeal psoriatic arthropathy
ICD-10L40.52
Psoriatic arthritis mutilans
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40.54
Psoriatic juvenile arthropathy
ICD-10L40.59
Other psoriatic arthropathy
ICD-9696.0
Psoriatic arthropathy
A Multicenter, Long-Term Extension to Evaluate the Long-term Safety and Maintenance of Treatment Effect of LY3074828 in Patients With Moderate-to-Severe Plaque Psoriasis OASIS-3
-
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
- YIH-AN KING Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Ya-Ching Chang Division of Dermatology
- Chung-Yao Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Tak-Wah Wong Division of Dermatology
- Chao-Kai Hsu Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chih-Chieh Chan Division of Dermatology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Plaque Psoriasis
Objectives
Primary Objectives
To evaluate the long-term maintenance of
efficacy of mirikizumab in patients with
moderate-to-severe plaque psoriasis
Secondary Objectives
To evaluate the long-term efficacy and patient
reported outcomes with mirikizumab
treatment in patients with moderate-to-severe
plaque psoriasis
Test Drug
Mirikizumab
Active Ingredient
Mirikizumab
Dosage Form
pre-filled syringe
Dosage
125
Endpoints
Primary Outcome Measures :
Percentage of Participants with a Static Physician's Global Assessment Among Those who Entered the Study with a sPGA of 0,1(sPGA) of (0,1) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants with an sPGA of (0,1) among those who entered the study with a sPGA of 0,1
Percentage of Participants who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those who Entered the Study with a PASI 90 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants who maintained a ≥90% improvement in PASI 90 among those who entered the study with a PASI 90.
Secondary Outcome Measures :
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of patients achieving a 100% improvement in PASI 100.
Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (free of itch, pain, stinging, and burning) in Those with a PSS Symptoms Score ≥1 at Baseline [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants with a PSS symptom score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score ≥1 at baseline.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0,1 with Baseline Score >1 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0,1 with baseline score >1.
Percent Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in PPASI total score in participants with palmoplantar involvement at baseline.
Percent Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline. [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in PSSI total score in participants with scalp involvement at baseline.
Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
Percentage of Participants with a Static Physician's Global Assessment Among Those who Entered the Study with a sPGA of 0,1(sPGA) of (0,1) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants with an sPGA of (0,1) among those who entered the study with a sPGA of 0,1
Percentage of Participants who Maintained a ≥90% Improvements in Psoriasis Area and Severity Index (PASI) 90 Among Those who Entered the Study with a PASI 90 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants who maintained a ≥90% improvement in PASI 90 among those who entered the study with a PASI 90.
Secondary Outcome Measures :
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of patients achieving a 100% improvement in PASI 100.
Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 (free of itch, pain, stinging, and burning) in Those with a PSS Symptoms Score ≥1 at Baseline [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants with a PSS symptom score of 0 (free of itch, pain, stinging, and burning) in those with a PSS symptoms score ≥1 at baseline.
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0,1 with Baseline Score >1 [ Time Frame: Baseline through Study Completion (Estimated up to Week 208) ]
Percentage of participants achieving Dermatology Life Quality Index (DLQI) score of 0,1 with baseline score >1.
Percent Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in PPASI total score in participants with palmoplantar involvement at baseline.
Percent Change from Baseline in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline. [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in PSSI total score in participants with scalp involvement at baseline.
Percent Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [ Time Frame: Baseline, End of Study (Estimated Week 208) ]
Percent change from baseline in NAPSI total score in participants with fingernail involvement at baseline.
Inclution Criteria
[1] Have completed the last visit of an eligible study period of 1 of the originator
studies (Study AMAF, AMAJ, AMAK, or AMBK).
[2a] Male patients
No male contraception required except in compliance with specific local
government study requirements.
[2b] Female Patients
Women not of child-bearing 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 of 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,
OR
At least 6 months (or longer if required by
local regulatory requirements) of spontaneous
amenorrhea with a follicle stimulating hormone
level of >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 child-bearing potential:
A. Must test negative for pregnancy prior to first dose in
Study AMAH as indicated 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, or 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 double-barrier 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, 1 of the 2 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).
When local guidelines concerning highly effective or effective methods
of birth control differ from the above, the local guidelines must be
followed.
[3] 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.
[4] Have given written informed consent as a legal adult according to local
regulations.
studies (Study AMAF, AMAJ, AMAK, or AMBK).
[2a] Male patients
No male contraception required except in compliance with specific local
government study requirements.
[2b] Female Patients
Women not of child-bearing 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 of 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,
OR
At least 6 months (or longer if required by
local regulatory requirements) of spontaneous
amenorrhea with a follicle stimulating hormone
level of >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 child-bearing potential:
A. Must test negative for pregnancy prior to first dose in
Study AMAH as indicated 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, or 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 double-barrier 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, 1 of the 2 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).
When local guidelines concerning highly effective or effective methods
of birth control differ from the above, the local guidelines must be
followed.
[3] 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.
[4] Have given written informed consent as a legal adult according to local
regulations.
Exclusion Criteria
[1] 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 that
developed during the originating mirikizumab study (Studies AMAF, AMAJ,
AMAK, or AMBK) that, in the opinion of the investigator, would potentially
affect patient safety within the study or would interfere with the interpretation
of data.
[2] Have a known hypersensitivity to mirikizumab or any component of this
investigational product.
[3] Have had investigational product permanently discontinued during a previous
mirikizumab study.
[4] Have had temporary investigational product interruption at any time during or
at the final study visit of a previous mirikizumab study and, in the opinion of
the investigator, restarting mirikizumab would pose 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
[7] 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.
cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine,
hematologic, or neurologic disease, or abnormal laboratory values that
developed during the originating mirikizumab study (Studies AMAF, AMAJ,
AMAK, or AMBK) that, in the opinion of the investigator, would potentially
affect patient safety within the study or would interfere with the interpretation
of data.
[2] Have a known hypersensitivity to mirikizumab or any component of this
investigational product.
[3] Have had investigational product permanently discontinued during a previous
mirikizumab study.
[4] Have had temporary investigational product interruption at any time during or
at the final study visit of a previous mirikizumab study and, in the opinion of
the investigator, restarting mirikizumab would pose 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
[7] 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
65 participants
-
Global
2000 participants
