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

AbbVie243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

243

Conditions

Hidradenitis Suppurativa

Interventions

RisankizumabDRUG

Risankizumab is administered as a SC injection in pre-filled syringe (PFS)

Placebo for risankizumabDRUG

Placebo for risankizumab is administered as a SC injection in PFS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

HiSCR is defined as at least a 50% reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess or draining fistula counts.

Time frame: Baseline (Week 0), Week 16

Secondary Outcomes

Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in Patient's Global Assessment (PGA) of Skin Pain Numerical Rating Scale (NRS30) at Week 8 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 8 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Time frame: Baseline (Week 0) to Week 8

Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA of Skin Pain Numerical Rating Scale (NRS30) at Week 16 Among Participants With Baseline Numerical Rating Scale (NRS) ≥ 3

NRS30 is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline at Week 16 in the PGA of Skin Pain (NRS30) - at worst, among participants with Baseline NRS ≥ 3, is presented.

Time frame: Baseline (Week 0) to Week 16

Percentage of Participants Who Experienced ≥ 25% Increase in Abscess and Inflammatory Nodule (AN) Counts in Period A With a Minimum Increase of 2 Relative to Baseline

Time frame: Baseline (Week 0) to Week 16

Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16

Data from ClinicalTrials.gov

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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

...and 49 more locations