A Study to Assess Safety and Efficacy of Risankizumab Using a New Formulation in Participants With Moderate to Severe Plaque Psoriasis

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
• Placebo solution for risankizumab — DRUG
  Placebo solution in prefilled syringes, self-administered subcutaneously

Study Details

The primary objective of this study was to evaluate the safety and efficacy of risankizumab (150 mg/mL) administered by prefilled syringe (PFS) for the treatment of adult participants with moderate to severe plaque psoriasis.

Key Dates

Start date

May 13, 2019

Status verified

Feb 2021

Primary completion

Feb 20, 2020

Completion

Jul 15, 2020

Study Design

Enrollment

157 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Risankizumab
  Subcutaneous (SC), self-administered 150 mg doses of risankizumab at Weeks 0, 4, and 16
• Placebo Comparator: Placebo
  Subcutaneous (SC), self-administered doses of placebo solution at Weeks 0, 4, and 16

Primary Outcome Measure

Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 at Week 16 [ Time Frame: At Week 16 ]

Locations (40)

Find similar trials in Birmingham, AL

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