Phase 2
Completed N=205
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Source: ClinicalTrials.gov NCT02899988 ↗Enrolled (actual)
205
Serious AEs
3.9%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) — 0; 29.4; 58.8; 66.7 percentage of participants — p=0.009
Summary
The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90) |
0; 29.4; 58.8; 66.7 | 0.009 sig |
| SECONDARY Percentage of Participants With a 100% Improvement in Psoriasis Area and Severity Index (PASI 100) |
0; 15.7; 31.4; 31.4 | 0.039 sig |
| SECONDARY Percentage of Participants With a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75) |
3.8; 52.9; 78.4; 74.5 | <0.001 sig |
| SECONDARY Percentage of Participants With a Static Physician Global Assessment (sPGA) 0 and 0/1 |
0; 15.7; 31.4; 31.4; 1.9; 37.3 | 0.041 sig |
| SECONDARY Mean Change From Baseline on the Psoriasis Symptom Scale (PSS) Total Score |
-4.35; -31.19; -42.33; -33.66 | <0.001 sig |
| SECONDARY Mean Change (Improvement) From Baseline on the Patient Global Assessment |
0.35; 2.24; 2.91; 2.82 | <0.001 sig |
| SECONDARY Mean Change From Baseline on the Dermatology Life Quality Index (DLQI) Total Score |
-1.07; -9.19; -10.18; -9.64 | <0.001 sig |
| SECONDARY Mean Change From Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores |
0.28; 2.39; 2.74; 1.52; 1.23; 4.58 | 0.009 sig |
| SECONDARY Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104 |
3.22; 8.94; 22.96; 46.4; 34.83; 47.66 | — |
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% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
- sPGA score of ≥3 at screening and baseline
- Candidate for biologic treatment for psoriasis.
Exclusion Criteria
- Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
- Breastfeeding or nursing (lactating) women.
- Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
- Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to 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 8 weeks prior to baseline.
- Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).
Data sourced from ClinicalTrials.gov (NCT02899988). 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.