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

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

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 Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Risankizumab; Drug: Placebo for risankizumab

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Phillip, Australian Capital Territory, Australia, 2606
      • Woden Dermatology /ID# 212437
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital /ID# 212438
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research /ID# 212432
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute Inc /ID# 212433
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology /ID# 215548
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital /ID# 212436
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology /ID# 212434
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research /ID# 212243
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Dr. Irina Turchin PC Inc. /ID# 212248
  • Ontario
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research /ID# 212166
  • Quebec
    • Saint-Jerome, Quebec, Canada, J7Z 7E2
      • Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
• France
  • Lyon, France, 69003
    • HCL - Hopital Edouard Herriot /ID# 218408
  • Reims, France, 51100
    • Polyclinique Courlancy /ID# 212567
  • Toulouse, France, 31400
    • CHU Toulouse - Hopital Larrey /ID# 213581
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06200
      • Chu de Nice-Hopital L'Archet Ii /Id# 212563
  • Ile-de-France
    • Antony, Ile-de-France, France, 92160
      • Hopital Prive d'Antony /ID# 212566
  • Loire
    • St. Priest En Jarez, Loire, France, 42270
      • CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
• Germany
  • Bochum, Germany, 44791
    • Klinikum Ruhr Univ Bochum /ID# 211910
  • Dessau, Germany, 06847
    • Staedtisches Klinikum Dessau /ID# 211914
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitaetsklinikum Frankfurt /ID# 211913
• Japan
  • Aichi
    • Nagoya shi, Aichi, Japan, 467-8602
      • Nagoya City University Hospital /ID# 211155
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital /ID# 211303
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Tohoku University Hospital /ID# 212214
  • Okinawa
    • Nakagami-gun, Okinawa, Japan, 903-0215
      • University of the Ryukyus Hospital /ID# 211373
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8470
      • Toranomon Hospital /ID# 211742
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis /ID# 212538
  • Noord-Brabant
    • Bergen op Zoom, Noord-Brabant, Netherlands, 4624 VT
      • Bravis Ziekenhuis /ID# 212536
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum /ID# 212535
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario Alicante /ID# 212010
  • Barcelona, Spain, 08041
    • Hospital Santa Creu i Sant Pau /ID# 212009
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de las Nieves /ID# 212014
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 212011
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria /ID# 212013
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
  • Valencia
    • Manises, Valencia, Spain, 46940
      • Hospital de Manises /ID# 211541
• United States
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913-6404
      • Burke Pharmaceutical Research /ID# 211671
  • California
    • Bakersfield, California, United States, 93309
      • Bakersfield Derma & Skin Cance /ID# 211684
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group /ID# 215958
    • Sacramento, California, United States, 95815-4500
      • Integrative Skin Science and Research /ID# 212550
    • Sacramento, California, United States, 95816-3300
      • UC Davis Health /ID# 211436
    • Thousand Oaks, California, United States, 91320-2130
      • California Dermatology Institute /ID# 211786
  • Connecticut
    • Cromwell, Connecticut, United States, 06416-1745
      • CCD Research, PLLC /ID# 214479
  • Georgia
    • Sandy Springs, Georgia, United States, 30328-6141
      • Advanced Medical Research /ID# 215203
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology /ID# 219096
  • Massachusetts
    • Boston, Massachusetts, United States, 02111-1552
      • Tufts Medical Center /ID# 212680
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 211794
  • Michigan
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology /ID# 212318
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455-0356
      • University of Minnesota /ID# 212319
    • New Brighton, Minnesota, United States, 55112
      • Minnesota Clinical Study Center /ID# 211979
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC /ID# 211675
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Campus /ID# 211800
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Res Center PC /ID# 211796
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033-2360
      • Penn State Hershey Medical Ctr /ID# 211659
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital /ID# 211807
  • Texas
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PL /ID# 215202
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Virginia Clinical Research, Inc. /ID# 215959
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research /ID# 211799

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab 180 mg; 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 is administered as a SC injection in pre-filled syringe (PFS); Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab 360 mg; In Period A, participants receive blinded risankizumab 360 mg via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	Drug: Risankizumab; Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Other Names: ABBV-066; SKYRIZI
Placebo Comparator: Placebo; In Period A, participants receive blinded placebo via a SC injection at Weeks 0 (Baseline), 1, 2, 4, and 12.	Drug: Placebo for risankizumab; Placebo for risankizumab is administered as a SC injection in PFS
Experimental: Risankizumab 180 mg / Risankizumab 360 mg; 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; Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Other Names: ABBV-066; SKYRIZI; Drug: Placebo for risankizumab; Placebo for risankizumab is administered as a SC injection in PFS
Experimental: Risankizumab 360 mg / Risankizumab 360 mg; 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; Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Other Names: ABBV-066; SKYRIZI; Drug: Placebo for risankizumab; Placebo for risankizumab is administered as a SC injection in PFS
Placebo Comparator: Placebo / Risankizumab 360 mg; 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; Risankizumab is administered as a SC injection in pre-filled syringe (PFS); Other Names: ABBV-066; SKYRIZI; Drug: Placebo for risankizumab; Placebo for risankizumab is administered as a SC injection in PFS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	The DLQI is a 10-item validated questionnaire used to assess the impact of HS disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. DLQI scores range from 0 to 30, with a higher score indicating a more impaired QoL.	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	HSSA is a 9-item participant-reported outcome (PRO) questionnaire developed to assess the symptoms of HS. HS-related swelling is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline (Week 0) to Week 16
Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16	HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related odor is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline (Week 0) to Week 16
Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16	HSSA is a 9-item PRO questionnaire developed to assess the symptoms of HS. HS-related worst drainage is scored on an 11-point NRS, where 0 represents no symptoms and 10 represents extreme symptom experience.	Baseline (Week 0) to Week 16

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): February 2, 2021
• Study Completion (Actual): August 2, 2021

Study Registration Dates

• First Submitted: April 23, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 24, 2019

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Placebo; Risankizumab; Hidradenitis Suppurativa
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: M16-833; 2019-000122-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No