Phase 3
Completed N=1,484
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Source: ClinicalTrials.gov NCT03535194 ↗Enrolled (actual)
1,484
Serious AEs
2.4%
Results posted
Mar 2021
Primary outcomePrimary: Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline — 6.3; 76.3; 79.7 percentage of participants — p=<0.001
◆ Published Evidence
Established
28citations · ~9 / year
Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study.
Summary
The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
Linked Publications
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Safety and efficacy of mirikizumab versus secukinumab and placebo in the treatment of moderate-to-severe plaque psoriasis (OASIS-2): a phase 3, multicentre, randomised, double-blind study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline |
6.3; 76.3; 79.7 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline |
6.3; 72.8; 74.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a 75% Improvement in PASI 75 |
8.0; 89.5; 89.5 | <0.001 sig |
| SECONDARY Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement |
1.8; 54.5; 53.1 | <0.001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those With PSS Symptom Score of ≥1 at Baseline |
1.9; 28.7; 25.0 | <0.001 sig |
| SECONDARY 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 |
5.9; 60.4; 59.6 | <0.001 sig |
| SECONDARY Change From Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline |
-1.33; -5.79; -6.28 | <0.001 sig |
| SECONDARY Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline |
-3.62; -18.22; -18.78 | <0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline |
0.20; -11.24; -9.38 | <0.001 sig |
| SECONDARY Change From Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) |
0.57; 4.38; 4.03 | <0.001 sig |
| SECONDARY Change From Baseline on the SF-36 Mental Component Summary (MCS) |
0.50; 4.21; 4.45 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Patient's Global Assessment (PatGA) of Disease Severity of (0,1) With at Least a 2-point Improvement From Baseline in Patients With a Baseline PatGA ≥2 |
7.3; 71.8; 72.3 | <0.001 sig |
| SECONDARY Change From Baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores |
-0.48; -2.48; -2.20; -3.36; -18.95; -18.95 | — |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11. |
-4.79; -5.10; -5.28 | 0.826 |
| SECONDARY Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab |
2.40 | — |
| SECONDARY Percentage of Participants With a Static Physician's Global Assessment (sPGA) of (0,1) With at Least a 2-point Improvement From Baseline (Non-inferiority) |
6.3; 76.3; 79.7 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) From Baseline (Non-inferiority) |
6.3; 72.8; 74.4 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Participant must have chronic plaque psoriasis for at least 6 months.
Exclusion Criteria
- Participant must not be breastfeeding or nursing woman.
- Participant must not have had serious, opportunistic, or chronic/recurring infection within 3 months.
- Participant must not 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.
- Participant must not have any other skin conditions (excluding psoriasis).
- Participant must not have previous exposure to Cosentyx and any other biologic therapy targeting IL-17 (including Taltz).
- Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8 weeks.
- Participant must not have previous exposure to any biologic therapy targeting IL-23 (including Stelara).
Data sourced from ClinicalTrials.gov (NCT03535194) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.