NCT03556202 is a Phase 3 clinical trial of Mirikizumab in Psoriasis, sponsored by Eli Lilly and Company.

Who is sponsoring NCT03556202?

NCT03556202 is sponsored by Eli Lilly and Company.

What drugs are being tested in NCT03556202?

Interventions in NCT03556202: Mirikizumab.

Is NCT03556202 still recruiting?

NCT03556202 is currently terminated. Last updated 21 March 2023.

Are results published for NCT03556202?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-21 · How we verify

NCT03556202

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)

Terminated Phase 3 Results posted Last updated 21 March 2023

What this trial tests

Phase 3 trial testing Mirikizumab in Psoriasis in 1,936 participants. Terminated before completion.

Timeline

3 September 2018

Primary endpoint
7 February 2022

7 February 2022

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1,936
Start date	3 September 2018
Primary completion	7 February 2022
Estimated completion	7 February 2022
Sites	229 locations across Italy, Japan, Taiwan, Poland, South Korea, Russia, Mexico, United States

Drugs / interventions tested

Mirikizumab (MIRIKIZUMAB) — full drug profile →

Conditions studied

Psoriasis — all drugs for Psoriasis →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, any sex, with Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With a Static Physician's Global Assessment Among Those Who Entered the Study With a sPGA of 0,1 Primary · Week 104

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. Participants who did not meet the clinical response criteria or had missing data at Week 104 were considered non-responders for non-responder Imputation (NR

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	46.7	42.2 – 51.2
250 mg Mirikizumab Q8W Excluding Secukinumab	55.7	52.3 – 59.1
Secukinumab/250 mg Mirikizumab Q8W	38.9	33.3 – 44.4

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 Primary · Week 104

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. 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

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	49.3	44.8 – 53.9
250 mg Mirikizumab Q8W Excluding Secukinumab	56.8	53.4 – 60.2
Secukinumab/250 mg Mirikizumab Q8W	39.4	33.9 – 44.9

Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) Secondary · Week 104

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	30.4	26.4 – 34.3
250 mg Mirikizumab Q8W Excluding Secukinumab	36.4	33.4 – 39.3
Secukinumab/250 mg Mirikizumab Q8W	22.6	18.5 – 26.8

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 Secondary · Week 104

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 sign

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	31.1	27.1 – 35.1
250 mg Mirikizumab Q8W Excluding Secukinumab	33.6	30.7 – 36.5
Secukinumab/250 mg Mirikizumab Q8W	23.4	19.1 – 27.7

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 Secondary · Week 104

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". 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 qual

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	41.5	37.1 – 45.9
250 mg Mirikizumab Q8W Excluding Secukinumab	47.3	44.1 – 50.5
Secukinumab/250 mg Mirikizumab Q8W	34.5	29.5 – 39.5

Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline Secondary · Baseline, Week 104

The PPASI 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.

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	-6.55	± 7.058
250 mg Mirikizumab Q8W Excluding Secukinumab	-6.80	± 8.391
Secukinumab/250 mg Mirikizumab Q8W	-7.38	± 6.632

Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline Secondary · Baseline, Week 104

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).

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	-20.9	± 15.79
250 mg Mirikizumab Q8W Excluding Secukinumab	-19.5	± 13.48
Secukinumab/250 mg Mirikizumab Q8W	-19.6	± 13.44

Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline Secondary · Baseline, Week 104

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).

Group	Value	95% CI
125 Milligram (mg) Mirikizumab Q8W	-19.4	± 17.75
250 mg Mirikizumab Q8W Excluding Secukinumab	-21.0	± 17.69
Secukinumab/250 mg Mirikizumab Q8W	-22.2	± 18.75

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment Period: Baseline Up To 160 Weeks, Follow-up Period: 0-12 Weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

125 Milligram (mg) Mirikizumab Q8W

Serious: 55/527 (10%)

Deaths: 2/527

250 mg Mirikizumab Q8W Excluding Secukinumab

Serious: 88/1020 (9%)

Deaths: 6/1020

Secukinumab/250 mg Mirikizumab Q8W

Serious: 35/389 (9%)

Deaths: 0/389

125 Milligram (mg) Mirikizumab Q8W Follow-up Period

Serious: 7/453 (2%)

Deaths: 1/453

250 mg Mirikizumab Q8W Excluding Secukinumab Follow-up Period

Serious: 6/861 (1%)

Deaths: 0/861

Secukinumab/250 mg Mirikizumab Q8W Follow-up Period

Serious: 0/333 (0%)

Deaths: 0/333

Serious adverse events (174 terms)

Reaction	System	125 Milligram (mg) Mirikiz…	250 mg Mirikizumab Q8W Exc…	Secukinumab/250 mg Mirikiz…	125 Milligram (mg) Mirikiz…	250 mg Mirikizumab Q8W Exc…	Secukinumab/250 mg Mirikiz…
Covid-19 pneumonia	Infections and infestations	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—	—
Erysipelas	Infections and infestations	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Clavicle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—	—
Angina unstable	Cardiac disorders	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—	—	—	—
Cardiogenic shock	Cardiac disorders	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—	—	—	—

Other adverse events (945 terms — click to expand)

Reaction	System	125 Milligram (mg) Mirikiz…	250 mg Mirikizumab Q8W Exc…	Secukinumab/250 mg Mirikiz…	125 Milligram (mg) Mirikiz…	250 mg Mirikizumab Q8W Exc…	Secukinumab/250 mg Mirikiz…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Covid-19	Infections and infestations	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Tooth extraction	Surgical and medical procedures	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Toothache	Gastrointestinal disorders	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Vaccination complication	Injury, poisoning and procedural complications	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Vaccination site pain	General disorders	—	—	—	—	—	—
Hepatic steatosis	Hepatobiliary disorders	—	—	—	—	—	—
Tinea pedis	Infections and infestations	—	—	—	—	—	—
Diabetes mellitus	Metabolism and nutrition disorders	—	—	—	—	—	—
Hypercholesterolaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Covid-19 pneumonia, Atrial fibrillation, Acute myocardial infarction, Cholecystitis acute, Covid-19, Myocardial infarction, Pancreatitis acute, Appendicitis.

Data from ClinicalTrials.gov NCT03556202 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the long-term safety and maintenance of efficacy of mirikizumab in participants with moderate-to-severe plaque psoriasis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Antibodies to watch in 2020.
Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
Antibodies to watch in 2021.
Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
Use of IL-23 Inhibitors for the Treatment of Plaque Psoriasis and Psoriatic Arthritis: A Comprehensive Review.
Yang K, Oak ASW, Elewski BE. · · 2021 · cited 129× · PMID 33301128 · DOI 10.1007/s40257-020-00578-0
Targeted Immunotherapy for Autoimmune Disease.
Jung SM, Kim WU. · · 2022 · cited 113× · PMID 35291650 · DOI 10.4110/in.2022.22.e9
Cellular rejuvenation: molecular mechanisms and potential therapeutic interventions for diseases.
Ji S, Xiong M, Chen H, Liu Y, et al · · 2023 · cited 89× · PMID 36918530 · DOI 10.1038/s41392-023-01343-5
Key Signaling Pathways in Psoriasis: Recent Insights from Antipsoriatic Therapeutics.
Ben Abdallah H, Johansen C, Johansen C, Iversen L. · · 2021 · cited 48× · PMID 34235053 · DOI 10.2147/ptt.s294173
Targeting Th17 cells: a promising strategy to treat oral mucosal inflammatory diseases.
Wang Y, Xue N, Wang Z, Zeng X, et al · · 2023 · cited 15× · PMID 37564654 · DOI 10.3389/fimmu.2023.1236856
Anti-IL23/12 agents and JAK inhibitors for inflammatory bowel disease.
Tian Z, Zhao Q, Teng X. · · 2024 · cited 13× · PMID 39086483 · DOI 10.3389/fimmu.2024.1393463

Verify or expand the search:

Other trials of Mirikizumab

Trials testing the same drug.

NCT06997965 — Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD · Phase 4 · not yet recruiting
NCT07059130 — Evaluating the Efficacy and Safety of Mirikizumab in Adults Over 60 With Moderate to Severe Crohn's Disease and Ulcerati · Phase 4 · not yet recruiting
NCT06626165 — Association Between Effectiveness of Mirikizumab and UC Patients With High Neutrophilic Infiltration in Epithelium of th · Phase 4 · completed
NCT05644353 — A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants · Phase 1 · completed
NCT05515601 — A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants · Phase 1 · completed

Other recruiting trials for Psoriasis

Currently open trials in the same condition.

NCT07471048 — A Study to Evaluate the Impact of a Magnolia Officinalis Dietary Supplement on Immune Biomarkers in Subjects With Psoria · NA · recruiting
NCT07449234 — A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis · recruiting
NCT07234838 — Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO) · recruiting
NCT07194200 — Safety and Efficacy of Lactobacillus Plantarum for Psoriasis: A Randomized Double-Blind Placebo-Controlled Trial · Phase 2 · recruiting
NCT07250997 — PALLAS Laser for Skin Diseases · NA · recruiting

Other Eli Lilly and Company trials

Trials by the same sponsor.

NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03556202 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 21 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03556202.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing