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

NCT03926169 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: M16-8332019-000122-21
• Study Type: interventional
• Target: 243
• Locations: 8 countries
• Sites: 59

Brief 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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Risankizumab; Placebo

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Week 0), Week 16

Secondary Outcomes (7)

• 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

  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

  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

  Baseline (Week 0) to Week 16

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

  Baseline (Week 0) to Week 16

• Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16

  Baseline (Week 0) to Week 16

Study Arms (6)

Risankizumab 180 mg

EXPERIMENTAL

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

Drug: Risankizumab

Risankizumab 360 mg

EXPERIMENTAL

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

Drug: Risankizumab

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo for risankizumab

Risankizumab 180 mg / Risankizumab 360 mg

EXPERIMENTAL

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.

Drug: Risankizumab; Drug: Placebo for risankizumab

Risankizumab 360 mg / Risankizumab 360 mg

EXPERIMENTAL

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.

Drug: Risankizumab; Drug: Placebo for risankizumab

Placebo / Risankizumab 360 mg

PLACEBO COMPARATOR

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.

Drug: Risankizumab; Drug: Placebo for risankizumab

Interventions

Risankizumab DRUG

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

Also known as: ABBV-066, SKYRIZI

Placebo / Risankizumab 360 mg; Risankizumab 180 mg; Risankizumab 180 mg / Risankizumab 360 mg; Risankizumab 360 mg; Risankizumab 360 mg / Risankizumab 360 mg

Placebo for risankizumab DRUG

Placebo for risankizumab is administered as a SC injection in PFS

Placebo; Placebo / Risankizumab 360 mg; Risankizumab 180 mg / Risankizumab 360 mg; Risankizumab 360 mg / Risankizumab 360 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (59)

Burke Pharmaceutical Research /ID# 211671

Hot Springs, Arkansas, 71913-6404, United States

Location

Bakersfield Derma & Skin Cance /ID# 211684

Bakersfield, California, 93309, United States

Location

Wallace Medical Group /ID# 215958

Los Angeles, California, 90056, United States

Location

Integrative Skin Science and Research /ID# 212550

Sacramento, California, 95815-4500, United States

Location

UC Davis Health /ID# 211436

Sacramento, California, 95816-3300, United States

Location

California Dermatology Institute /ID# 211786

Thousand Oaks, California, 91320-2130, United States

Location

CCD Research, PLLC /ID# 214479

Cromwell, Connecticut, 06416-1745, United States

Location

Advanced Medical Research /ID# 215203

Sandy Springs, Georgia, 30328-6141, United States

Location

Arlington Dermatology /ID# 219096

Rolling Meadows, Illinois, 60008, United States

Location

Tufts Medical Center /ID# 212680

Boston, Massachusetts, 02111-1552, United States

Location

Beth Israel Deaconess Medical Center /ID# 211794

Boston, Massachusetts, 02215-5400, United States

Location

Hamzavi Dermatology /ID# 212318

Fort Gratiot, Michigan, 48059, United States

Location

University of Minnesota /ID# 212319

Minneapolis, Minnesota, 55455-0356, United States

Location

Minnesota Clinical Study Center /ID# 211979

New Brighton, Minnesota, 55112, United States

Location

Skin Specialists, PC /ID# 211675

Omaha, Nebraska, 68144, United States

Location

Montefiore Medical Center - Moses Campus /ID# 211800

The Bronx, New York, 10467, United States

Location

Oregon Medical Res Center PC /ID# 211796

Portland, Oregon, 97223, United States

Location

Penn State Hershey Medical Ctr /ID# 211659

Hershey, Pennsylvania, 17033-2360, United States

Location

Rhode Island Hospital /ID# 211807

Providence, Rhode Island, 02903, United States

Location

Modern Research Associates, PL /ID# 215202

Dallas, Texas, 75231, United States

Location

Virginia Clinical Research, Inc. /ID# 215959

Norfolk, Virginia, 23507, United States

Location

Premier Clinical Research /ID# 211799

Spokane, Washington, 99202, United States

Location

Woden Dermatology /ID# 212437

Phillip, Australian Capital Territory, 2606, Australia

Location

Westmead Hospital /ID# 212438

Westmead, New South Wales, 2145, Australia

Location

Veracity Clinical Research /ID# 212432

Woolloongabba, Queensland, 4102, Australia

Location

Skin Health Institute Inc /ID# 212433

Carlton, Victoria, 3053, Australia

Location

Sinclair Dermatology /ID# 215548

East Melbourne, Victoria, 3002, Australia

Location

The Royal Melbourne Hospital /ID# 212436

Parkville, Victoria, 3050, Australia

Location

Fremantle Dermatology /ID# 212434

Fremantle, Western Australia, 6160, Australia

Location

Wiseman Dermatology Research /ID# 212243

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr. Irina Turchin PC Inc. /ID# 212248

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043

Newmarket, Ontario, L3Y 5G8, Canada

Location

K. Papp Clinical Research /ID# 212166

Waterloo, Ontario, N2J 1C4, Canada

Location

Dre Angelique Gagne-Henley M.D. inc. /ID# 212249

Saint-Jérôme, Quebec, J7Z 7E2, Canada

Location

Chu de Nice-Hopital L'Archet Ii /Id# 212563

Nice, Alpes-Maritimes, 06200, France

Location

CHU de SAINT ETIENNE - Hopital Nord /ID# 212564

Saint Priest EN Jarez, Pays de la Loire Region, 42270, France

Location

HCL - Hopital Edouard Herriot /ID# 218408

Lyon, 69003, France

Location

Polyclinique Courlancy /ID# 212567

Reims, 51100, France

Location

CHU Toulouse - Hopital Larrey /ID# 213581

Toulouse, 31400, France

Location

Hopital Prive d'Antony /ID# 212566

Antony, Île-de-France Region, 92160, France

Location

Universitaetsklinikum Frankfurt /ID# 211913

Frankfurt am Main, Hesse, 60590, Germany

Location

Klinikum Ruhr Univ Bochum /ID# 211910

Bochum, 44791, Germany

Location

Staedtisches Klinikum Dessau /ID# 211914

Dessau, 06847, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912

Hamburg, 20246, Germany

Location

Nagoya City University Hospital /ID# 211155

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital /ID# 211303

Fukuoka, Fukuoka, 814-0180, Japan

Location

Tohoku University Hospital /ID# 212214

Sendai, Miyagi, 9808574, Japan

Location

University of the Ryukyus Hospital /ID# 211373

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Toranomon Hospital /ID# 211742

Minato-ku, Tokyo, 105-8470, Japan

Location

Bravis Ziekenhuis /ID# 212536

Bergen op Zoom, North Brabant, 4624 VT, Netherlands

Location

Erasmus Medisch Centrum /ID# 212535

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Amphia Ziekenhuis /ID# 212538

Breda, 4818 CK, Netherlands

Location

Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015

Sabadell, Barcelona, 08208, Spain

Location

Hospital de Manises /ID# 211541

Manises, Valencia, 46940, Spain

Location

Hospital General Universitario Alicante /ID# 212010

Alicante, 03010, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 212009

Barcelona, 08041, Spain

Location

Hospital Universitario Virgen de las Nieves /ID# 212014

Granada, 18014, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 212011

Madrid, 28007, Spain

Location

Hospital Universitario Virgen de la Victoria /ID# 212013

Málaga, 29010, Spain

Location

Related Publications (1)

• Kimball AB, Prens EP, Passeron T, Maverakis E, Turchin I, Beeck S, Drogaris L, Geng Z, Zhan T, Messina I, Bechara FG. Efficacy and Safety of Risankizumab for the Treatment of Hidradenitis Suppurativa: A Phase 2, Randomized, Placebo-Controlled Trial. Dermatol Ther (Heidelb). 2023 May;13(5):1099-1111. doi: 10.1007/s13555-023-00913-3. Epub 2023 Mar 9.

  PMID: 36892753 DERIVED

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

risankizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 24, 2019
• Study Start: June 3, 2019
• Primary Completion: February 2, 2021
• Study Completion: August 2, 2021
• Last Updated: August 11, 2022
• Results First Posted: August 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

Locations

CA (5); FR (6); JP (5); AU (7); DE (4); ES (7); US (22); NL (3)