A Phase 3 Study in Participants With Moderate to Severe Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 80 mg Ixekizumab Dosing Regimens 1, 2, and 3 — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

This study will assess the safety and efficacy of LY2439821 compared to placebo in participants with moderate to severe, chronic plaque psoriasis.

Key Dates

Start date

Nov 16, 2011

Status verified

Jan 2019

Primary completion

Jun 24, 2014

Completion

Sep 20, 2018

Study Design

Enrollment

1,296 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 80 milligrams (mg) Ixekizumab Dosing Regimen 1 (Q2W)
  Administered as two 80-mg subcutaneous (SC) injections at Week 0, then one 80-mg SC injection per Dosing Regimen 1 \[every 2 weeks (Q2W)\] up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 \[every 4 weeks (Q4W)\] or Dosing Regimen 3 \[every 12 weeks Q12W)\].
• Experimental: 80 mg Ixekizumab Dosing Regimen 2 (Q4W)
  Administered as two 80-mg SC injections at Week 0, then one 80-mg SC injection per Dosing Regimen 2 (Q4W) up to and including Week 10. At Week 12, arm is re-randomized to placebo, Dosing Regimen 2 (Q4W) or Dosing Regimen 3 (Q12W).
• Experimental: 80 mg Ixekizumab Dosing Regimen 3 (Q12W)
  Dosing Regimen 3 (Q12W) is not used until Week 12. At Week 12, participants who were re-randomized to this arm were administered one 80-mg SC injection Q12W.
• Placebo Comparator: Placebo
  Administered as 2 SC injections at Week 0, then 1 SC injection per Dosing Regimen 1 (Q2W) up to and including Week 10. At Week 12, arm is re-randomized to placebo or Dosing Regimen 2 (Q4W).

Primary Outcome Measure

Percentage of Participants With Static Physician Global Assessment (sPGA) of 0 or 1 (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Ps Measure: sPGA) [ Time Frame: Week 12 ]

Locations (34)

Find similar trials in Birmingham, AL

Related Studies

• Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
  Recruiting · University of California, San Diego · La Jolla, California
• Regulation of Inflammatory Genes in Psoriasis
  Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
• Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Birmingham, Alabama
• A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
  PHASE4 · Recruiting · Bausch Health Americas, Inc. · Fountain Valley, California