A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixekizumab — DRUG
  Administered SQ
• Placebo — DRUG
  Administered SQ

Study Details

The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.

Key Dates

Start date

Aug 31, 2015

Status verified

Jun 2020

Primary completion

Nov 30, 2016

Completion

Aug 3, 2017

Study Design

Enrollment

1,257 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 80 mg Ixekizumab Q2W
  160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind.
• Experimental: 80 mg Ixekizumab Q4W
  160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
• Experimental: 80 mg Ixekizumab Q4W/Q2W
  160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
• Experimental: 80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
  160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
• Experimental: 80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
  160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
• Experimental: 80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
  160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.

Primary Outcome Measure

Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1) [ Time Frame: Week 52 ]

Locations (59)

Find similar trials in Birmingham, AL

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