A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa (DETERMINED 1)

AbbVie

Status and phase: Completed; Phase 2

Conditions: Hidradenitis Suppurativa

Treatments: Drug: Placebo for risankizumab; Drug: Risankizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03926169

2019-000122-21 (EudraCT Number)

M16-833

Details and patient eligibility

About

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.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant with moderate to severe HS for at least 1 year prior to baseline visit.
• HS lesions present in at least two distinct anatomical areas.
• Draining fistula count of ≤ 20 at Baseline visit.
• Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
• Participants are required to use a daily antiseptic wash on their HS lesions.
• Participant must have a history of inadequate response or intolerance to an adequate trial of oral antibiotics for treatment of HS.

Exclusion criteria

• Participant has a history of active skin disease other than HS that could interfere with the assessment of HS.
• Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection.
• Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3 months or 5 half-lives, whichever is longer, prior to baseline.
• Participant has received prescription topical therapies (including topical antibiotics) within 14 days prior to the Baseline visit.
• Participant has received systemic non-biologic therapies that can also be used to treat HS within 4 weeks prior to the Baseline visit.
• Participant has received any systemic (including oral) antibiotic treatment within 4 weeks prior to the Baseline visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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243 participants in 6 patient groups, including a placebo group

Risankizumab 180 mg

Experimental group

Description:

In Period A, participants receive blinded risankizumab 180 mg via a subcutaneous (SC) injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Treatment:

Drug: Risankizumab

Risankizumab 360 mg

Experimental group

Description:

In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Treatment:

Drug: Risankizumab

Placebo

Placebo Comparator group

Description:

In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.

Treatment:

Drug: Placebo for risankizumab

Risankizumab 180 mg / Risankizumab 360 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo for risankizumab

Drug: Risankizumab

Risankizumab 360 mg / Risankizumab 360 mg

Experimental group

Description:

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.

Treatment:

Drug: Placebo for risankizumab

Drug: Risankizumab

Placebo / Risankizumab 360 mg

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo for risankizumab

Drug: Risankizumab