A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Ustekinumab — DRUG
  45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.
• Guselkumab — DRUG
  100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.
• Placebo for ustekinumab — DRUG
  Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.
• Placebo for guselkumab — DRUG
  Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.

Study Details

The purpose of this study is to evaluate the efficacy and safety of guselkumab (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis (scaly skin rash) who had inadequate response to ustekinumab.

Key Dates

Start date

Oct 7, 2014

Status verified

Aug 2017

Primary completion

Dec 25, 2015

Completion

May 24, 2016

Study Design

Enrollment

872 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Open-label ustekinumab
• Experimental: Double-blind guselkumab
• Experimental: Double-blind ustekinumab

Primary Outcome Measure

Number of Visits at Which Participants Achieved an Investigator's Global Assessment (IGA) Response of Cleared (0) or Minimal (1) and at Least a 2 Grade Improvement (From Week 16) From Week 28 Through Week 40 [ Time Frame: Week 28 through Week 40 ]

Locations (29)

Find similar trials in Birmingham, AL

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