Phase 3
Completed N=530
A Study to Evaluate the Efficacy and Safety of Mirikizumab (LY3074828) in Participants With Moderate-to-Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT03482011 ↗Enrolled (actual)
530
Serious AEs
1.2%
Results posted
Sep 2020
Primary outcomePrimary: Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline — 6.5; 69.3 Percentage of participants — p=<0.001
◆ Published Evidence
Emerging
11citations · ~6 / year
Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis.
Summary
The purpose of this study is to evaluate the efficacy and safety of mirikizumab in participants with moderate to severe plaque psoriasis.
Linked Publications
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Comparison of Drug-Free Remission after the End of Phase III Trials of Three Different Anti-IL-23 Inhibitors in Psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Static Physician's Global Assessment of (sPGA) (0,1) With at Least a 2-point Improvement From Baseline |
6.5; 69.3 | <0.001 sig |
| PRIMARY Percentage of Participants Achieving a ≥90% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 90) |
6.5; 64.3 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) |
9.3; 82.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a ≥75% Improvement From Baseline in PASI (PASI 75) |
9.3; 82.5 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a ≥100% Improvement From Baseline in Psoriasis Area and Severity Score (PASI 100) |
0.9; 32.4 | <0.001 sig |
| SECONDARY Percentage of Participants With ≤1% of Body Surface Area (BSA) With Psoriasis Involvement |
0.9; 49.2 | <0.001 sig |
| SECONDARY Percentage of Participants With a Psoriasis Symptoms Scale (PSS) Symptoms Score of 0 in Those With a PSS Symptoms Score ≥1 at Baseline |
0; 19.0 | <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 |
5.4; 54.7 | <0.001 sig |
| SECONDARY Percentage of Participants Maintaining Clinical Response (PASI 90) After Re-randomization at the Start of the Randomized Withdrawal Period |
18.7; 85.6; 84.6 | <0.001 sig |
| SECONDARY Change in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants With Palmoplantar Involvement at Baseline |
-1.13; -5.83 | <0.001 sig |
| SECONDARY Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants With Scalp Involvement at Baseline |
-2.70; -20.03 | <0.001 sig |
| SECONDARY Change in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants With Fingernail Involvement at Baseline |
-2.04; -9.01 | <0.001 sig |
| SECONDARY Change From Baseline on the Short Form (SF)-36 Physical Component Summary (PCS) |
0.35; 5.21 | <0.001 sig |
| SECONDARY Change From Baseline on the SF-36 Mental Component Summary (MCS) |
0.32; 5.10 | <0.001 sig |
| SECONDARY Percentage of Participants With Patient's Global Assessment of Psoriasis (PatGA (0,1)) and >=2 Improvement From Baseline |
1.0; 69.5 | <0.001 sig |
| SECONDARY Change From Baseline on the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) |
0.10; -3.57; -4.54; -24.79; -3.45; -24.54 | 0.002 sig |
| SECONDARY Change From Baseline in Quick Inventory of Depressive Symptomology (QIDS-SR16) Total Score in Those With a Baseline QIDS-SR16 Total Score ≥11 |
-4.95; -4.42 | 0.004 sig |
| SECONDARY Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) (0,1) |
8.7; 57.1 | <0.001 sig |
| SECONDARY Induction Period: Pharmacokinetics (PK): Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab at Week 16 |
2.00 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03482011) 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.