A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

Conditions

• Hidradenitis Suppurativa

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Risankizumab — DRUG
  Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
• Placebo for risankizumab — DRUG
  Placebo for risankizumab is administered as a SC injection in PFS

Study Details

The primary objective of this study is to assess the safety and efficacy of risankizumab 180 mg and 360 mg versus placebo for the treatment of signs and symptoms of moderate to severe hidradenitis suppurativa (HS) in adult participants diagnosed for at least one year before the Baseline visit.

Key Dates

Start date

Jun 3, 2019

Status verified

Jul 2022

Primary completion

Feb 2, 2021

Completion

Aug 2, 2021

Study Design

Enrollment

243 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Risankizumab 180 mg
  In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
• Experimental: Risankizumab 360 mg
  In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
• Placebo Comparator: Placebo
  In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.
• Experimental: Risankizumab 180 mg / Risankizumab 360 mg
  In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg every 8 weeks (q8w) at Weeks 20, 28, 36, 44, 52, and 60.
• Experimental: Risankizumab 360 mg / Risankizumab 360 mg
  In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded placebo at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.
• Placebo Comparator: Placebo / Risankizumab 360 mg
  In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12. In Period B, participants receive blinded risankizumab 360 mg at Weeks 16, 17, and 18. Starting at Week 20, participants receive open-label risankizumab 360 mg q8w at Weeks 20, 28, 36, 44, 52, and 60.

Primary Outcome Measure

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16 [ Time Frame: Baseline (Week 0), Week 16 ]

Locations (22)

Find similar trials in Hot Springs, AR

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