EUCTR2015-002628-14-AT
Active, not recruiting
Phase 1
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients with Moderate-to-Severe Genital Psoriasis - IXORA-Q
ConditionsModerate-to-severe genital psoriasisMedDRA version: 20.0Level: LLTClassification code 10063407Term: Psoriasis genitalSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
DrugsTaltz
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderate-to-severe genital psoriasis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 146
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Are male or female patients of 18 years or older
- •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
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 131
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
- •Serious disorder or illness other than plaque psoriasis
- •Active or history of malignant disease within 5 years prior to baseline
- •Serious infection with the last 3 months
Outcomes
Primary Outcomes
Not specified
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