Clinical trial NCT03926169: A Global Study Comparing Risankizumab to Placebo in Adult Participants With Moderate to Severe Hidradenitis Suppurativa
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hidradenitis Suppurativa
Keywords: Hidradenitis Suppurativa
Risankizumab
Placebo
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
timeFrame: Baseline (Week 0), Week 16
Secondary outcomes:
measure: 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
timeFrame: Baseline (Week 0) to Week 8
measure: 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
timeFrame: Baseline (Week 0) to Week 16
measure: 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
timeFrame: Baseline (Week 0) to Week 16
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16
timeFrame: Baseline (Week 0) to Week 16
measure: Change From Baseline in HS-Related Swelling Based on the Hidradenitis Suppurativa Symptom Assessment (HSSA) Swollen Skin Score at Week 16
timeFrame: Baseline (Week 0) to Week 16
measure: Change From Baseline in HS-Related Odor Based on the HSSA Bad Smell Score at Week 16
timeFrame: Baseline (Week 0) to Week 16
measure: Change From Baseline in HS-Related Worst Drainage Based on the HSSA Worst Drainage Score at Week 16
timeFrame: Baseline (Week 0) to Week 16
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research /ID# 211671
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Derma & Skin Cance /ID# 211684
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group /ID# 215958
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research /ID# 212550
state: California
city: Sacramento
country: United States
facility: UC Davis Health /ID# 211436
state: California
city: Thousand Oaks
country: United States
facility: California Dermatology Institute /ID# 211786
state: California
city: Cromwell
country: United States
facility: CCD Research, PLLC /ID# 214479
state: Connecticut
city: Sandy Springs
country: United States
facility: Advanced Medical Research /ID# 215203
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology /ID# 219096
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center /ID# 212680
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 211794
state: Massachusetts
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology /ID# 212318
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota /ID# 212319
state: Minnesota
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center /ID# 211979
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC /ID# 211675
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus /ID# 211800
state: New York
city: Portland
country: United States
facility: Oregon Medical Res Center PC /ID# 211796
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Ctr /ID# 211659
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital /ID# 211807
state: Rhode Island
city: Dallas
country: United States
facility: Modern Research Associates, PL /ID# 215202
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc. /ID# 215959
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research /ID# 211799
state: Washington
city: Phillip
country: Australia
facility: Woden Dermatology /ID# 212437
state: Australian Capital Territory
city: Westmead
country: Australia
facility: Westmead Hospital /ID# 212438
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research /ID# 212432
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute Inc /ID# 212433
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology /ID# 215548
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital /ID# 212436
state: Victoria
city: Fremantle
country: Australia
facility: Fremantle Dermatology /ID# 212434
state: Western Australia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research /ID# 212243
state: Manitoba
city: Fredericton
country: Canada
facility: Dr. Irina Turchin PC Inc. /ID# 212248
state: New Brunswick
city: Newmarket
country: Canada
facility: Dr. S.K. Siddha Medicine Professional Corporation /ID# 219043
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 212166
state: Ontario
city: Saint-Jerome
country: Canada
facility: Dre Angelique Gagne-Henley M.D. inc. /ID# 212249
state: Quebec
city: Nice
country: France
facility: Chu de Nice-Hopital L'Archet Ii /Id# 212563
state: Alpes-Maritimes
city: Antony
country: France
facility: Hopital Prive d'Antony /ID# 212566
state: Ile-de-France
city: St. Priest En Jarez
country: France
facility: CHU de SAINT ETIENNE - Hopital Nord /ID# 212564
state: Loire
city: Lyon
country: France
facility: HCL - Hopital Edouard Herriot /ID# 218408
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 212567
city: Toulouse
country: France
facility: CHU Toulouse - Hopital Larrey /ID# 213581
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt /ID# 211913
state: Hessen
city: Bochum
country: Germany
facility: Klinikum Ruhr Univ Bochum /ID# 211910
city: Dessau
country: Germany
facility: Staedtisches Klinikum Dessau /ID# 211914
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 211912
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 211155
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 211303
state: Fukuoka
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 212214
state: Miyagi
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 211373
state: Okinawa
city: Minato-ku
country: Japan
facility: Toranomon Hospital /ID# 211742
state: Tokyo
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis /ID# 212536
state: Noord-Brabant
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 212535
state: Zuid-Holland
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis /ID# 212538
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 212015
state: Barcelona
city: Manises
country: Spain
facility: Hospital de Manises /ID# 211541
state: Valencia
city: Alicante
country: Spain
facility: Hospital General Universitario Alicante /ID# 212010
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 212009
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves /ID# 212014
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 212011
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria /ID# 212013
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: