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

Hidradenitis Suppurativa Clinical Trial

— DETERMINED 1  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

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

External Links

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