A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis (IXORA-Q)

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis; Genital Psoriasis

Treatments: Drug: Placebo; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02718898

16010

2015-002628-14 (EudraCT Number)

I1F-MC-RHBQ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups, including a placebo group

Ixekizumab

Experimental group

Description:

Blinded Treatment Period: 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab every 2 weeks (Q2W) SC from week 2 to week 10. At week 12, 80 mg ixekizumab and placebo given SC. Open Label Period: 80 mg ixekizumab given SC every 4 weeks (Q4W) with an option for Q2W dosing starting at week 24, week 28 or week 40.

Treatment:

Drug: Placebo

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Blinded Treatment Period: Placebo given SC at baseline followed by placebo given SC Q2W from week 2 to week 10. At week 12, 160 mg ixekizumab given SC. Open Label Period: 80 mg ixekizumab given SC Q4W with an option for Q2W dosing starting at week 24, week 28 or week 40.

Treatment:

Drug: Placebo

Drug: Ixekizumab