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

Part of paid clinical trials in Santa Ana, California.

Sponsor
Eli Lilly and Company
Study ID
NCT02718898
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixekizumab — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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.

Key Dates

Start date
Apr 30, 2016
Status verified
Aug 2019
Primary completion
Feb 22, 2017
Completion
Feb 21, 2018

Study Design

Enrollment
149 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Number of Participants Achieving Static Physician Global Assessment (sPGA) of Genitalia (0,1) [ Time Frame: Week 12 ]

Locations (13)

FacilityCityStateZIPSite coordinators
Southern California DermatologySanta AnaCalifornia92701-
Clinical Science InstituteSanta MonicaCalifornia90404-
Olympian Clinical ResearchTampaFlorida33609-
Advanced Medical ResearchSandy SpringsGeorgia30328-
Dawes Fretzin Clinical ResearchIndianapolisIndiana46256-
The South Bend ClinicSouth BendIndiana46617-
Tufts Medical CenterBostonMassachusetts02111-
Oregon Medical Research CenterPortlandOregon97223-
Clinical Partners LLCJohnstonRhode Island02919-
Menter Dermatology Research InstituteDallasTexas75246-
Modern Research Associates PLLCDallasTexas75231-
Pflugerville Dermatology Clinical Research CenterPflugervilleTexas78660-
University of UtahSalt Lake CityUtah84132-

Find similar trials in Santa Ana, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Southern California Dermatology· Santa Ana, CAClinical Science Institute· Santa Monica, CAOlympian Clinical Research· Tampa, FLAdvanced Medical Research· Sandy Springs, GADawes Fretzin Clinical Research· Indianapolis, INThe South Bend Clinic· South Bend, IN

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