Clinical trial NCT02718898: A Study of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Genital Psoriasis
Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genital Psoriasis
Psoriasis
Keywords: genital
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1)
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants Achieving Overall sPGA (0,1)
timeFrame: Week 12
measure: Number 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)
timeFrame: Week 12
measure: Number of Participants Whose Frequency of Sexual Activity is Never or Rarely Limited by Genital Psoriasis, Utilizing the Genital Psoriasis Sexual Frequency Questionnaire (SFQ) Item 2
timeFrame: Week 12
measure: Number of Participants Whose Frequency of Avoiding Sexual Activity is Either Never or Rarely Limited by Genital Psoriasis in the Sexual Activity Avoidance Subscale Score of the Genital Psoriasis Sexual Impact Scale (GPSIS)
timeFrame: Week 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
timeFrame: Baseline, Week 12
measure: Change From Baseline in Modified Genital Psoriasis Area and Severity Index (mGPASI) Score
timeFrame: Baseline, Week 12
measure: Number of Participants With at Least a 2-Point Change in Patient's Global Assessment of Genital Psoriasis (PatGA-Genital)
timeFrame: Week 12
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Physical Component Summary (PCS)
timeFrame: Baseline, Week 12
measure: Change From Baseline on the Short-Form Health Survey (SF-36) Mental Component Summary (MCS)
timeFrame: Baseline, Week 12
measure: Change From Baseline in Genital Psoriasis Symptom Scale (GPSS) Total Score and Individual Items
timeFrame: Baseline, Week 12
measure: Number of Participants Achieving sPGA of Genitalia (0,1) at Week 12 by Treatment-Emergent Anti-Drug Antibody (TE-ADA) Status and by Neutralizing Antibody (NAb) Status
timeFrame: Week 12
Other outcomes:
Locations:
city: Santa Ana
country: United States
facility: Southern California Dermatology
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research
state: Georgia
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research
state: Indiana
city: South Bend
country: United States
facility: The South Bend Clinic
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Johnston
country: United States
facility: Clinical Partners LLC
state: Rhode Island
city: Dallas
country: United States
facility: Modern Research Associates PLLC
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Pflugerville
country: United States
facility: Pflugerville Dermatology Clinical Research Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Adelaide
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Carlton
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Darlinghurst
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Woolloongabba
country: Australia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Graz
country: Austria
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wien
country: Austria
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wien
country: Austria
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brussels
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Brussels
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gent
country: Belgium
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: London
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Markham
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Montreal
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Quebec
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Surrey
country: Canada
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Bergen op Zoom
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Breda
country: Netherlands
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: Bursa
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Gaziantep
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Istanbul
country: Turkey
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: