A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
A Phase 2 Multicenter, Investigator-Blind, Subject-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
2 other identifiers
interventional
90
8 countries
31
Brief Summary
Hidradenitis suppurativa (HS) is a painful, long-term skin condition that causes abscesses and scarring on the skin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2017
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2017
CompletedFirst Posted
Study publicly available on registry
August 14, 2017
CompletedStudy Start
First participant enrolled
September 22, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2019
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedApril 11, 2022
January 1, 2022
1.2 years
August 2, 2017
November 22, 2021
March 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Achieving Clinical Response as Measured by Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
HiSCR was defined as at least a 50 % reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count. Results were based on a Bayesian logistic regression model where the number of responders were assumed to follow a binomial distribution. Participants with missing data at Week 12 were considered as nonresponders in the analysis. Posterior mean response rates and 95% credible intervals in each group are presented.
Week 12
Secondary Outcomes (41)
Bimekizumab Plasma Concentration at Day 1 (Prior to First Dose)
Day 1 (Prior to first dose)
Bimekizumab Plasma Concentration at Week 2
Week 2
Bimekizumab Plasma Concentration at Week 4
Week 4
Bimekizumab Plasma Concentration at Week 8
Week 8
Bimekizumab Plasma Concentration at Week 12
Week 12
- +36 more secondary outcomes
Study Arms (3)
Bimekizumab
EXPERIMENTALSubjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
Adalimumab
ACTIVE COMPARATORSubjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
Placebo
PLACEBO COMPARATORSubjects will receive several placebo applications to keep the blinding.
Interventions
Eligibility Criteria
You may qualify if:
- Adult subjects (18 to 70 years of age, inclusive) must have a diagnosis of HS for at least
- year prior to Baseline
- Stable HS for at least 2 months prior to Screening and also at the Baseline Visit
- Inadequate response to at least a 3-month study of an oral antibiotic for treatment of HS
- Total abscess and inflammatory nodule count \>=3 at the Baseline Visit
- Subject must agree to daily use (and throughout the entirety of the study) of 1 pre-specified over-the-counter topical antiseptics on their HS lesions
- Female subjects must be postmenopausal, permanently sterilized or, if of childbearing potential, must be willing to use a highly effective method of contraception up till 20 weeks after last administration of study drug and have a negative pregnancy test at Visit 1 (Screening) and immediately prior to first dose
- Male subjects must be willing to use a method of contraception when sexually active, up till 20 weeks after the last administration of study medication
You may not qualify if:
- Prior treatment with anti-IL17s or participation in an anti-IL17 study
- Previously received anti-TNFs
- Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol)
- Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline Visit
- Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline Visit
- Draining fistula count \>20 at the Baseline Visit
- Diagnosis of inflammatory conditions other than HS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Hs0001 121
Los Angeles, California, 90033, United States
Hs0001 119
Coral Gables, Florida, 33134, United States
Hs0001 111
Orange, Florida, 32073, United States
Hs0001 117
Tampa, Florida, 33624, United States
Hs0001 112
Sandy Springs, Georgia, 30328, United States
Hs0001 113
Boston, Massachusetts, 02215, United States
Hs0001 115
Las Vegas, Nevada, 89074, United States
Hs0001 126
Manhasset, New York, 11030, United States
Hs0001 125
Chapel Hill, North Carolina, 27599, United States
Hs0001 123
Hershey, Pennsylvania, 17033, United States
Hs0001 120
Nashville, Tennessee, 37215, United States
Hs0001 103
East Melbourne, Australia
Hs0001 101
Fremantle, Australia
Hs0001 104
Saint Leonards, Australia
Hs0001 100
Westmead, Australia
Hs0001 102
Woolloongabba, Australia
Hs0001 203
Brussels, Belgium
Hs0001 202
Liège, Belgium
Hs0001 300
Copenhagen, Denmark
Hs0001 408
Berlin, Germany
Hs0001 405
Bochum, Germany
Hs0001 407
Darmstadt, Germany
Hs0001 400
Dessau, Germany
Hs0001 404
Erlangen, Germany
Hs0001 406
Würzburg, Germany
Hs0001 503
Athens, Greece
Hs0001 701
Harstad, Norway
Hs0001 700
Tromsø, Norway
Hs0001 901
Moscow, Russia
Hs0001 903
Saint Petersburg, Russia
Hs0001 900
Yaroslavl, Russia
Related Publications (1)
Glatt S, Jemec GBE, Forman S, Sayed C, Schmieder G, Weisman J, Rolleri R, Seegobin S, Baeten D, Ionescu L, Zouboulis CC, Shaw S. Efficacy and Safety of Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: A Phase 2, Double-blind, Placebo-Controlled Randomized Clinical Trial. JAMA Dermatol. 2021 Nov 1;157(11):1279-1288. doi: 10.1001/jamadermatol.2021.2905.
PMID: 34406364RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1-844-599-2273 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
August 2, 2017
First Posted
August 14, 2017
Study Start
September 22, 2017
Primary Completion
November 23, 2018
Study Completion
February 21, 2019
Last Updated
April 11, 2022
Results First Posted
February 9, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share