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A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects With Moderate to Severe Hidradenitis Suppurativa

NCT03926169•AbbVie

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.

Locations (59)

Burke Pharmaceutical Research /ID# 211671

Hot Springs, Arkansas, United States

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

Key Dates

Start Date

June 3, 2019

Primary Completion Date

February 2, 2021

Completion Date

August 2, 2021

Last Updated

August 11, 2022

Enrollment

243

ACTUAL participants

Conditions

Hidradenitis Suppurativa

Interventions

Risankizumab

DRUG

Placebo for risankizumab

DRUG

A Study With CIT-013 in HS Patients

NCT06993233

Hidradenitis Suppurativa (HS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study With CIT-013 in HS Patients

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

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