A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)
- Conditions
- Moderate-to-severe genital psoriasisMedDRA version: 20.0Level: LLTClassification code 10063407Term: Psoriasis genitalSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-002628-14-AT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 146
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
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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess whether ixekizumab is superior to placebo at Week 12 in the treatment of patients with moderate-to-severe genital psoriasis as<br>measured by sPGA of Genitalia;Secondary Objective: To assess whether ixekizumab is superior to placebo at week 12 in the treatment of patients with moderate-to-severe genital psoriasis as measured by change in itch<br>To assess whether ixekizumab is superior to placebo at week 12 in the treatment of patients with moderate-to-severe genital psoriasis as measured by overall sPGA<br>To assess whether ixekizumab is superior to placebo at Week 12 in the treatment of patients with moderate-to-severe genital psoriasis as measured by limitation of frequency of sexual activity due to genital psoriasis;Primary end point(s): Proportion of Participants Achieving Static Physician Global Assessment(sPGA) of Genitalia (0,1);Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of Participants Achieving Overall sPGA (0,1)<br><br>Proportion 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)<br><br>Proportion of Participants whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Sexual Frequency Questionnaire (SFQ) item 2;Timepoint(s) of evaluation of this end point: 12 weeks