A Study to Test the Efficacy, Safety and Pharmacokinetics of Bimekizumab in Subjects With Moderate to Severe Hidradenitis Suppurativa.
NCT ID: NCT03248531
Last Updated: 2022-04-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2017-09-22
2019-02-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Bimekizumab
Subjects will receive one Bimekizumab loading dose 1 and several Bimekizumab dose 2 applications.
Bimekizumab
Bimekizumab in different dosages (dose 1 and 2).
Adalimumab
Subjects will receive one Adalimumab loading (dose 1) and several Adalimumab dose 2 and dose 3 applications.
Adalimumab
Adalimumab in different dosages (dose 1, 2 and 3).
Placebo
Subjects will receive several placebo applications to keep the blinding.
Placebo
Placebo will be provided matching Bimekizumab.
Interventions
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Bimekizumab
Bimekizumab in different dosages (dose 1 and 2).
Adalimumab
Adalimumab in different dosages (dose 1, 2 and 3).
Placebo
Placebo will be provided matching Bimekizumab.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1-844-599-2273 (UCB)
Locations
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Hs0001 121
Los Angeles, California, United States
Hs0001 119
Coral Gables, Florida, United States
Hs0001 111
Orange, Florida, United States
Hs0001 117
Tampa, Florida, United States
Hs0001 112
Sandy Springs, Georgia, United States
Hs0001 113
Boston, Massachusetts, United States
Hs0001 115
Las Vegas, Nevada, United States
Hs0001 126
Manhasset, New York, United States
Hs0001 125
Chapel Hill, North Carolina, United States
Hs0001 123
Hershey, Pennsylvania, United States
Hs0001 120
Nashville, Tennessee, 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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2017-000892-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HS0001
Identifier Type: -
Identifier Source: org_study_id
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