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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa

In brief

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 facts

Study ID

NCT03926169

Run by

AbbVie

People needed

243

Starts

2019-06-03

Expected to finish

2021-08-02

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Bakersfield Derma & Skin Cance /ID# 211684 — Bakersfield, California, United States
• Wallace Medical Group /ID# 215958 — Los Angeles, California, United States
• Integrative Skin Science and Research /ID# 212550 — Sacramento, California, United States
• UC Davis Health /ID# 211436 — Sacramento, California, United States
• California Dermatology Institute /ID# 211786 — Thousand Oaks, California, United States
• CCD Research, PLLC /ID# 214479 — Cromwell, Connecticut, United States
• Advanced Medical Research /ID# 215203 — Sandy Springs, Georgia, United States
• Arlington Dermatology /ID# 219096 — Rolling Meadows, Illinois, United States
• Tufts Medical Center /ID# 212680 — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center /ID# 211794 — Boston, Massachusetts, United States
• Hamzavi Dermatology /ID# 212318 — Fort Gratiot, Michigan, United States
• University of Minnesota /ID# 212319 — Minneapolis, Minnesota, United States
• Minnesota Clinical Study Center /ID# 211979 — New Brighton, Minnesota, United States
• Skin Specialists, PC /ID# 211675 — Omaha, Nebraska, United States
• Montefiore Medical Center - Moses Campus /ID# 211800 — The Bronx, New York, United States
• Oregon Medical Res Center PC /ID# 211796 — Portland, Oregon, United States
• Penn State Hershey Medical Ctr /ID# 211659 — Hershey, Pennsylvania, United States
• Rhode Island Hospital /ID# 211807 — Providence, Rhode Island, United States
• Modern Research Associates, PL /ID# 215202 — Dallas, Texas, United States
• Virginia Clinical Research, Inc. /ID# 215959 — Norfolk, Virginia, United States
• Premier Clinical Research /ID# 211799 — Spokane, Washington, United States
• Woden Dermatology /ID# 212437 — Phillip, Australian Capital Territory, Australia
• Westmead Hospital /ID# 212438 — Westmead, New South Wales, Australia
• Veracity Clinical Research /ID# 212432 — Woolloongabba, Queensland, Australia
• Burke Pharmaceutical Research /ID# 211671 — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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