EUCTR2015-002628-14-ATActive, not recruitingPhase 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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 146
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
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
- •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
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated with Docetaxel / Prednisone for Metastatic Androgen-Independent Prostate Cancer - VENICEPatients with metastatic androgen-independent prostate cancerEUCTR2006-004756-20-GBsanofi-aventis recherche & développement1,200
Active, not recruiting
Phase 1
A clinical trial in patients with moderate to severe plaque psoriasis comparing the efficacy and safety of taking a drug called Ixekizumab either every 4 weeks or every 2 weeks.EUCTR2015-000190-12-CZEli Lilly and Company1,200
Active, not recruiting
Phase 1
A clinical trial in patients with moderate to severe plaque psoriasis comparing the efficacy and safety of taking a drug called Ixekizumab either every 4 weeks or every 2 weeks.Moderate to severe plaque psoriasisMedDRA version: 18.1Level: LLTClassification code 10071117Term: Plaque psoriasisSystem Organ Class: 100000004858EUCTR2015-000190-12-PLEli Lilly and Company1,200
Active, not recruiting
Phase 1
A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)EUCTR2015-002628-14-NL146
Active, not recruiting
Not Applicable
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated with Docetaxel / Prednisone for Metastatic Androgen-Independent Prostate Cancer - VENICEEUCTR2006-004756-20-HUsanofi-aventis recherche & développement1,200