- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482011
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-1)
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Berlin, Germany, 10789
- ISA GmbH
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Berlin, Germany, 10117
- Charite Universitatsmedizin Berlin
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg - Eppendorf
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Hamburg, Germany, 22143
- Clinical Research Hamburg GmbH
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Brandenburg
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Mahlow, Brandenburg, Germany, 15831
- Gemeinschaftspraxis Mahlow
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Nordrhein-Westfalen
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Münster, Nordrhein-Westfalen, Germany, 48149
- Universitatsklinikum Munster
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Sachsen
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Dresden, Sachsen, Germany, 01097
- Praxis Gerlach
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Chiba
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Sakura, Chiba, Japan, 285-8741
- Toho University School of Medicine, Sakura Hospital
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Hokkaido
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Obihiro, Hokkaido, Japan, 080-0013
- Takagi Dermatological Clinic
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Kanagawa
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Kawasaki, Kanagawa, Japan, 211-8510
- Kanto Rosai Hospital
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Yokohama, Kanagawa, Japan, 236-0004
- Yokohama City University Hospital
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Okinawa
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Nakagami-gun, Okinawa, Japan, 903-0215
- Ryukyu University Hospital
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Osaka
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Nishi-ku Sakai-shi, Osaka, Japan, 593-8324
- Kume Clinic
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Shimane
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Izumo, Shimane, Japan, 693-8501
- Shimane University Hospital
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Tokyo
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Hachioji, Tokyo, Japan, 193-0998
- Tokyo Medical University Hachioji Medical Center
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Shinagawa-KU, Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku, Tokyo, Japan, 160-0023
- Tokyo Medical University Hospital
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Shinjuku-ku, Tokyo, Japan, 161-8521
- Seibo Hospital
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Toyama
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Takaoka-shi, Toyama, Japan, 9330871
- Shirasaki Clinic
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Daejeon, Korea, Republic of, 35015
- Chungnam National University Hospital
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Gwangju, Korea, Republic of, 61469
- Chonnam National University Hospital
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Seoul, Korea, Republic of, 03722
- Severance Hospital Yonsei University Health System
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Seoul, Korea, Republic of, 04763
- Hanyang University Medical Center
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Seoul, Korea, Republic of, 05030
- Konkuk University Hospital
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Gyeonggi-do
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Bucheon,, Gyeonggi-do, Korea, Republic of, 14647
- Bucheon St. Mary's Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
- Seoul National University Bundang Hospital
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Sungnam-si, Gyeonggi-do, Korea, Republic of, 13496
- Bundang CHA General Hospital
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Suwon, Gyeonggi-do, Korea, Republic of, 16499
- Ajou University Hospital
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Korea
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Seoul, Korea, Korea, Republic of, 02447
- Kyung Hee University Hospital
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Seoul, Korea, Korea, Republic of, 08308
- Korea University Guro Hospital
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Ulsan, Korea, Korea, Republic of, 44033
- Ulsan University Hospital
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Distrito Federal, Mexico, 3100
- RM Pharma Specialists S.A. de C.V.
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Durango, Mexico, 34000
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C
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Baja California
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Mexicali, Baja California, Mexico, 21100
- Centro Medico del Angel S.C.
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 06090
- Hospital de Jesús
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Jalisco
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Zapopan, Jalisco, Mexico, 45190
- Instituto Dermatologico de Jalisco Dr. Jose Barba Rubio
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Michoacan
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Morella, Michoacan, Mexico, 58249
- Clínica Enfermedades Crónicas y Procedimientos Especiales SC
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Sinaloa
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Mazatlan, Sinaloa, Mexico, 82140
- B&B Investigaciones Medicas, SC
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Yucatan
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Merida, Yucatan, Mexico, 97070
- Kohler Milstein Research, S.A. de C.V.
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Bialystok, Poland, 15-351
- Nzoz Zdrowie Osteo-Medic
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Lodz, Poland, 90-265
- "DERMED" Centrum Medyczne Sp. z o.o.
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Swidnik, Poland, 21-040
- Lubelskie Centrum Diagnostyczne
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Warszawa, Poland, 01-518
- Centrum Medyczne AMED
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Wroclaw, Poland, 51-318
- Dermmedica Sp. Z O.O.
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Carolina, Puerto Rico, 00985
- Office of Dr. Alma M. Cruz
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San Juan, Puerto Rico, 00909
- GCM Medical Group PSC
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Krasnodar, Russian Federation, 350000
- GBUZ Clinical dermatology and venereological dispensary
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Moscow, Russian Federation, 119991
- First Moscow State Medical University n.a. Sechenov
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Moscow, Russian Federation, 107076
- State scientific centre for dermatovenerology and cosmetolog
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Smolensk, Russian Federation, 214000
- GOU VPO 'Smolensk State Medical Academy of Ministry of Health and Social Development of Russian Federation'
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St. Petersburg, Russian Federation, 194021
- SPb SBHI Skin-venerologic dispensary #10
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Tver, Russian Federation, 170100
- Tver State Medical University
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Hsinchu, Taiwan, 30059
- National Taiwan University Hospital Hsin-Chu
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Kaohsiung, Taiwan, 83301
- Chang Gung Memorial Hospital - Kaohsiung
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New Taipei City, Taiwan, 23561
- Taipei Medical University- Shuang Ho Hospital
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Taichung City, Taiwan, 40201
- Chung Shan Medical University Hospital
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Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
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Taoyuan Hsien, Taiwan, 10508
- Chang Gung Memorial Hospital - Linkou
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Zhongzheng District
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Taipei City, Zhongzheng District, Taiwan, 100
- National Taiwan University Hospital
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Connecticut
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Farmington, Connecticut, United States, 06032
- Univ of Connecticut
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Florida
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Coral Gables, Florida, United States, 33134
- Florida Academic Dermatology Centers
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Ocala, Florida, United States, 34470
- Renstar Medical Research
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Tampa, Florida, United States, 33624
- Forward Clinical Trials, Inc
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Illinois
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Rolling Meadows, Illinois, United States, 60008
- Arlington Dermatology
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Indiana
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South Bend, Indiana, United States, 46617
- The South Bend Clinic
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Oregon
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Portland, Oregon, United States, 97223
- Oregon Medical Research Center
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Pennsylvania
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Exton, Pennsylvania, United States, 19341
- Dermatology and Skin Surgery Center
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Utah
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Murray, Utah, United States, 84107
- University of Utah MidValley Dematology
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Washington
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Tacoma, Washington, United States, 98405
- MultiCare Health System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:
- plaque psoriasis involving ≥10% BSA and absolute PASI score ≥12 in affected skin at screening and baseline
- sPGA score of ≥3 at screening and baseline
- Candidate for systemic therapy and/or phototherapy for psoriasis.
Exclusion Criteria:
- 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 participant safety within the study or of interfering with the interpretation of data.
- Breastfeeding or nursing women.
- Have had serious, opportunistic, or chronic/recurring infection within 3 months prior to screening.
- 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.
- Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
- Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
- Have received topical psoriasis treatment within 14 days prior to baseline.
- Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 12 weeks prior to baseline.
- Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Mirikizumab
Induction Period: Participants received 250 milligrams (mg) mirikizumab administered subcutaneously (SC) every 4 weeks (Q4W). Maintenance Period: Participants received one of the four options below: Placebo administered SC every 8 weeks (Q8W) for responders (≥PASI 90). 125 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q8W for non-responders (<PASI 90). |
Administered SC
Other Names:
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Placebo Comparator: Placebo
Induction Period: Participants received placebo administered SC Q4W. Maintenance Period: Participants received one of the two options below: Placebo administered SC Q8W for responders (≥PASI 90). 250 mg mirikizumab administered SC Q4W during week 16 to week 32 and Q8W during week 40 and 48 for non-responders (< PASI 90). |
Administered SC
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline
Time Frame: Week 16
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The sPGA is the physician's determination of the participant's psoriasis (PsO) lesions overall at a given time point.
Lesions were categorized by descriptions for induration, erythema, and scaling.
Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
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Week 16
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Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90)
Time Frame: Week 16
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PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no PsO) to 72 (the most severe disease).
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Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
Time Frame: Week 4
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PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no PsO) to 72 (the most severe disease).
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Week 4
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Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75)
Time Frame: Week 16
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PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no PsO) to 72 (the most severe disease).
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Week 16
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Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100)
Time Frame: Week 16
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PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no PsO) to 72 (the most severe disease).
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Week 16
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Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement
Time Frame: Week 16
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The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb).
The total BSA affected was the summation of individual regions affected.
Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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Week 16
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Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline
Time Frame: Week 16
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PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs.
The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign.
In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported.
Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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Week 16
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Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) With at Least a 5-Point Improvement (Reduction) From Baseline in Participants With a Baseline DLQI Total Score ≥5
Time Frame: Week 16
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The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively.
Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0".
For all questions, if unanswered the question is scored as "0".
Totals range from 0 to 30 (less to more impairment).
A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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Week 16
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Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period
Time Frame: Week 52
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PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease.
For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement).
Each area is scored separately and the scores then combined for the final PASI.
Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)].
Overall scores range from 0 (no PsO) to 72 (the most severe disease).
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Week 52
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Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline
Time Frame: Week 16
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The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI).
The PPASI was only assessed if participants have palmoplantar psoriasis at baseline.
Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
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Week 16
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Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline
Time Frame: Week 16
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The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe).
The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
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Week 16
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Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline
Time Frame: Week 16
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The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement.
The fingernail is divided into quadrants.
Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant.
The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis).
LS Mean was calculated using MMRM model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates.
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Week 16
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Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS)
Time Frame: Baseline, Week 16
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SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item.
The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores.
The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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Baseline, Week 16
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Change From Baseline on the SF-36 Mental Component Summary (MCS)
Time Frame: Baseline, Week 16
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SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item.
The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores.
The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health.
LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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Baseline, Week 16
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Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline
Time Frame: Baseline, Week 16
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The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been).
Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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Baseline, Week 16
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Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO)
Time Frame: Baseline, Week 16
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The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work.
Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work.
Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes.
LS Mean was calculated using Analysis of covariance (ANCOVA) model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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Baseline, Week 16
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Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11
Time Frame: Baseline, Week 16
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QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression.
A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst).
The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Whereas 0-5 indicates no symptoms.
LS Mean was calculated using ANCOVA model with treatment and baseline value, previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as fixed factors.
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Baseline, Week 16
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Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1)
Time Frame: Week 16
|
The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment.
Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively.
Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0".
For all questions, if unanswered the question is scored as "0".
Totals range from 0 to 30 (less to more impairment).
A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold.
Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
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Week 16
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Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16
Time Frame: Week 16: Day 113
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Minimum observed serum concentration at steady state (Ctrough,ss) of mirikizumab at Week 16.
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Week 16: Day 113
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Mirikizumab
Other Study ID Numbers
- 16505
- I6T-MC-AMAK (Other Identifier: Eli Lilly and Company)
- 2017-003298-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
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ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
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Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
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Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
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Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
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UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
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AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
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TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
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Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
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Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
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Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on Placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
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Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
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GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
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ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
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GlaxoSmithKlineCompletedInfections, BacterialUnited States
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West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States