Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe 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 Auto-Injector — DRUG
  Administered SC by auto-injector
• Ixekizumab Prefilled Syringe — DRUG
  Administered SC by prefilled syringe

Study Details

The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.

Key Dates

Start date

Mar 31, 2013

Status verified

Sep 2019

Primary completion

May 31, 2014

Completion

May 31, 2015

Study Design

Enrollment

204 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 80 mg Ixekizumab Auto-Injector
  Ixekizumab administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every 2 weeks (Q2W) at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection every 4 weeks (Q4W).
• Experimental: 80 mg Ixekizumab Prefilled Syringe
  Ixekizumab administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10. Starting from Week 12, 80 mg Ixekizumab Prefilled Syringe was administered by one 80 mg SC injection Q4W.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device [ Time Frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) ]

Locations (22)

Find similar trials in Anaheim, CA

Related Studies

• Understanding Participation Habits Among Plaque Psoriasis Patients
  Not Yet Recruiting · Power Life Sciences Inc. · San Francisco, California
• A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama
• A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis
  PHASE1 · Recruiting · Ascletis Pharma (China) Co., Limited · Miami, Florida
• Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
  PHASE3 · Recruiting · Bristol-Myers Squibb · Birmingham, Alabama