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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03926169
Other study ID # M16-833
Secondary ID 2019-000122-21
Status Completed
Phase Phase 2
First received
Last updated
Start date June 3, 2019
Est. completion date August 2, 2021

Study information

Verified date July 2022
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 243
Est. completion date August 2, 2021
Est. primary completion date February 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Risankizumab
Risankizumab is administered as a SC injection in pre-filled syringe (PFS)
Placebo for risankizumab
Placebo for risankizumab is administered as a SC injection in PFS

Locations

Country Name City State
Australia Skin Health Institute Inc /ID# 212433 Carlton Victoria
Australia Sinclair Dermatology /ID# 215548 East Melbourne Victoria
Australia Fremantle Dermatology /ID# 212434 Fremantle Western Australia
Australia The Royal Melbourne Hospital /ID# 212436 Parkville Victoria
Australia 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
Canada Dr. Irina Turchin PC Inc. /ID# 212248 Fredericton New Brunswick
Canada Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043 Newmarket Ontario
Canada Dre Angelique Gagne-Henley M.D. inc. /ID# 212249 Saint-Jerome Quebec
Canada K. Papp Clinical Research /ID# 212166 Waterloo Ontario
Canada Wiseman Dermatology Research /ID# 212243 Winnipeg Manitoba
France Hopital Prive d'Antony /ID# 212566 Antony Ile-de-France
France HCL - Hopital Edouard Herriot /ID# 218408 Lyon
France Chu de Nice-Hopital L'Archet Ii /Id# 212563 Nice Alpes-Maritimes
France Polyclinique Courlancy /ID# 212567 Reims
France CHU de SAINT ETIENNE - Hopital Nord /ID# 212564 St. Priest En Jarez Loire
France CHU Toulouse - Hopital Larrey /ID# 213581 Toulouse
Germany Klinikum Ruhr Univ Bochum /ID# 211910 Bochum
Germany Staedtisches Klinikum Dessau /ID# 211914 Dessau
Germany Universitaetsklinikum Frankfurt /ID# 211913 Frankfurt am Main Hessen
Germany Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912 Hamburg
Japan Fukuoka University Hospital /ID# 211303 Fukuoka-shi Fukuoka
Japan Toranomon Hospital /ID# 211742 Minato-ku Tokyo
Japan Nagoya City University Hospital /ID# 211155 Nagoya shi Aichi
Japan University of the Ryukyus Hospital /ID# 211373 Nakagami-gun Okinawa
Japan Tohoku University Hospital /ID# 212214 Sendai-shi Miyagi
Netherlands Bravis Ziekenhuis /ID# 212536 Bergen op Zoom Noord-Brabant
Netherlands Amphia Ziekenhuis /ID# 212538 Breda
Netherlands Erasmus Medisch Centrum /ID# 212535 Rotterdam Zuid-Holland
Spain Hospital General Universitario Alicante /ID# 212010 Alicante
Spain Hospital Santa Creu i Sant Pau /ID# 212009 Barcelona
Spain Hospital Universitario Virgen de las Nieves /ID# 212014 Granada
Spain Hospital General Universitario Gregorio Maranon /ID# 212011 Madrid
Spain Hospital Universitario Virgen de la Victoria /ID# 212013 Malaga
Spain Hospital de Manises /ID# 211541 Manises Valencia
Spain Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015 Sabadell Barcelona
United States Bakersfield Derma & Skin Cance /ID# 211684 Bakersfield California
United States Beth Israel Deaconess Medical Center /ID# 211794 Boston Massachusetts
United States Tufts Medical Center /ID# 212680 Boston Massachusetts
United States Montefiore Medical Center - Moses Campus /ID# 211800 Bronx New York
United States CCD Research, PLLC /ID# 214479 Cromwell Connecticut
United States Modern Research Associates, PL /ID# 215202 Dallas Texas
United States Hamzavi Dermatology /ID# 212318 Fort Gratiot Michigan
United States Penn State Hershey Medical Ctr /ID# 211659 Hershey Pennsylvania
United States Burke Pharmaceutical Research /ID# 211671 Hot Springs Arkansas
United States Wallace Medical Group /ID# 215958 Los Angeles California
United States University of Minnesota /ID# 212319 Minneapolis Minnesota
United States Minnesota Clinical Study Center /ID# 211979 New Brighton Minnesota
United States Virginia Clinical Research, Inc. /ID# 215959 Norfolk Virginia
United States Skin Specialists, PC /ID# 211675 Omaha Nebraska
United States Oregon Medical Res Center PC /ID# 211796 Portland Oregon
United States Rhode Island Hospital /ID# 211807 Providence Rhode Island
United States Arlington Dermatology /ID# 219096 Rolling Meadows Illinois
United States Integrative Skin Science and Research /ID# 212550 Sacramento California
United States UC Davis Health /ID# 211436 Sacramento California
United States Advanced Medical Research /ID# 215203 Sandy Springs Georgia
United States Premier Clinical Research /ID# 211799 Spokane Washington
United States California Dermatology Institute /ID# 211786 Thousand Oaks California

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Japan,  Netherlands,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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