Phase 3
N=149
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Genital Psoriasis · Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02718898 ↗Enrolled (actual)
149
Serious AEs
2.6%
Results posted
Mar 2018
Primary outcome: Primary: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) — 6; 55 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ixekizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) |
6; 55 | <0.001 sig |
| SECONDARY Number of Participants Achieving Overall sPGA (0,1) |
2; 55 | <0.001 sig |
| SECONDARY Number of Participants With at Least a 3 Point Improvement in Genital Psoriasis Itch Numeric Rating Scale (NRS) Item Within the Genital Psoriasis Symptom Scale (GPSS) |
5; 37 | <0.001 sig |
| SECONDARY Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2 |
9; 29 | <0.001 sig |
| SECONDARY Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS) |
9; 23 | <0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score |
-1.4; -9.7 | <0.001 sig |
| SECONDARY Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score |
-3.9; -23.9 | <0.001 sig |
| SECONDARY Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital) |
11; 51 | <0.001 sig |
| SECONDARY Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS) |
0.687; 5.193 | <0.001 sig |
| SECONDARY Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS) |
2.186; 3.982 | 0.085 |
| SECONDARY Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items |
-2.82; -31.57; -0.21; -4.02; -0.34; -3.84 | <0.001 sig |
| SECONDARY Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status |
5; 6; 50; 5 | — |
Summary
The main purpose of this study is to evaluate the efficacy and safety of the study drug ixekizumab compared to placebo in participants with moderate-to-severe genital psoriasis.
Eligibility Criteria
Inclusion Criteria
- Have chronic plaque psoriasis based on a diagnosis of chronic plaque psoriasis for at least 6 months before baseline.
- Have moderate-to-severe psoriasis in the genital area at screening and baseline.
- Have plaque psoriasis in a nongenital area at screening and baseline.
- Have failed to respond to, or are intolerant of, at least 1 topical therapy used for treatment of psoriasis affecting the genital area.
- Must agree to use reliable method of birth control, which could include abstinence, during the study and for at least 12 weeks following the last dose of study drug.
Exclusion Criteria
- Pustular, erythrodermic, and/or guttate forms of psoriasis.
- History of drug-induced psoriasis.
- Have recently received certain treatments for psoriasis (in particular, within the past 4 weeks but the restriction can go up to 12 months for some treatments).
- Have ever received treatment with ixekizumab, secukinumab, brodalumab, or another drug with a similar mode of action.
- Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to baseline and during the study.
- Are currently enrolled in any other clinical trial involving an investigational product.
- Serious disorder or illness other than plaque psoriasis.
- Active or history of malignant disease within 5 years prior to baseline.
- Serious infection within the last 3 months.
- Have received a live vaccine within 3 months of baseline or plan to do so during the study.
- Have received a vaccination with Bacillus Calmette-Guérin (BCG) within the past year.
- Pregnant or breastfeeding (lactating) women.
Data sourced from ClinicalTrials.gov (NCT02718898). 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.