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Ixekizumab vs Placebo in Moderate-to-Severe Genital Psoriasis
NCT02718898Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2016
- Primary completion
- Feb 2017
- Countries
- 8
- Sponsor
- Eli Lilly and Company
- Modality
- Monoclonal Antibodies
- Drugs
- ixekizumab
- Conditions
- genital psoriasis
01
Overview
Phase 3, randomised, double-blind trial in genital psoriasis comparing Ixekizumab with Placebo (2 arms). Primary endpoint: Static Physician Global Assessment of Genitalia (0,1) at 12 weeks. Started Apr 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ixekizumab
160 mg SC at Week 0, then 80 mg Q2W to Week 12
Placebo
Placebo SC at Week 0 and Q2W to Week 12
03
Who it enrols
Adult patients with chronic plaque psoriasis for at least 6 months and moderate-to-severe genital psoriasis (sPGA-G >= 3) who have failed at least one topical therapy. Patients must also have plaque psoriasis in a non-genital area (BSA >= 1%).
04
Endpoints
Primary
Static Physician Global Assessment of Genitalia (0,1)
Secondary
Overall Static Physician Global Assessment (0,1)
Genital Psoriasis Itch Numeric Rating Scale
Genital Psoriasis Sexual Frequency Questionnaire Item 2
Genital Psoriasis Sexual Impact Scale - Sexual Activity Avoidance Subscale
Dermatology Life Quality Index
Modified Genital Psoriasis Area and Severity Index
Patient's Global Assessment of Genital Psoriasis
Short-Form Health Survey Physical Component Summary
05
Results
Primary endpoints met
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