Clinical trial NCT02963506: A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Official title: A Multicenter, Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: AS
Ankylosing Spondylitis
Bimekizumab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 303
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: This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).


Eligibility criteria: Inclusion Criteria:

* Subject has active ankylosing spondylitis (AS), determined by documented radiologic evidence fulfilling the Modified New York criteria for AS including symptoms for \>=3 months and age of onset \<45 years
* Subject has moderate to severe active disease as defined by each of the following:

  1. BASDAI score \>=4
  2. Spinal pain \>=4 on a 0 to 10 NRS (Numeric Rating Scale; from BASDAI item 2)
* Subjects must have at least 1 of the following:

  1. inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
  2. intolerance to administration of at least 1 NSAID
  3. contraindication(s) to NSAID therapy
* Subjects who are regularly taking NSAIDs/COX-2 inhibitors as part of their AS therapy are required to be on a stable dose for at least 14 days before Baseline
* Subjects taking corticosteroids must be on an average daily dose of \<=10mg/day prednisone or equivalent for at least 14 days before Baseline and should remain on a stable dose up to Week 16
* Subjects taking methotrexate (MTX) (\<=25mg/week) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
* Subjects taking sulfasalazine (up to 3grams/day) or hydroxychloroquine (up to 400mg per day total) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 8 weeks before randomization
* Subjects may be tumor necrosis factor (TNF) inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:

  1. experienced an inadequate response to previous treatment given for at least 12 weeks
  2. been intolerant to administration (eg, had a side effect/adverse event that led to discontinuation)
  3. lost access to TNF inhibitor for other reasons

Exclusion Criteria:

* Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg, rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, or reactive arthritis
* Subjects with any current sign or symptom that may indicate an active infection (except for the common cold)
* Subjects with a history of chronic or recurrent infections, or a serious or life-threatening infection within the 6 months prior to the Baseline Visit
* Subjects receiving any live vaccination within the 8 weeks prior to Baseline
* Subjects with known tuberculosis (TB) infection, at high risk of acquiring TB infection, with latent TB infection or current or history of nontuberculous mycobacteria (NTMB) infection
* Subjects with concurrent malignancy or a history of malignancy during the past 5 years will be excluded, with following exceptions that may be included:

  1. \<= 3 excised or ablated basal cell carcinomas of the skin
  2. One squamous cell carcinoma of the skin (stage T1 maximum) successfully excised, or ablated only (other treatments, ie, chemotherapy, do not apply), with no signs of recurrence or metastases for more than 2 years prior to Screening
  3. Actinic keratosis (-es)
  4. Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening

Primary outcomes:
measure: Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
timeFrame: From Baseline to Week 12
measure: Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12
timeFrame: Week 12
measure: Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: From Baseline to Week 12
measure: Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: From Baseline to Week 12
measure: Percentage of Participants With at Least One Adverse Event (AE) During the Study
timeFrame: From Screening until Safety Follow-Up Visit (up to Week 77)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study
timeFrame: From Screening until Safety Follow-Up Visit (up to Week 77)
measure: Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study
timeFrame: From Screening until Safety Follow-Up Visit (up to Week 77)
Other outcomes:
Locations:
city: Anniston
country: United States
facility: As0008 019
state: Alabama
city: La Jolla
country: United States
facility: As0008 007
state: California
city: Upland
country: United States
facility: As0008 009
state: California
city: Aventura
country: United States
facility: As0008 005
state: Florida
city: Ormond Beach
country: United States
facility: As0008 022
state: Florida
city: Sarasota
country: United States
facility: As0008 030
state: Florida
city: Boston
country: United States
facility: As0008 027
state: Massachusetts
city: Freehold
country: United States
facility: As0008 021
state: New Jersey
city: Cleveland
country: United States
facility: As0008 015
state: Ohio
city: Portland
country: United States
facility: As0008 014
state: Oregon
city: Duncansville
country: United States
facility: As0008 001
state: Pennsylvania
city: Austin
country: United States
facility: As0008 020
state: Texas
city: Dallas
country: United States
facility: As0008 006
state: Texas
city: Houston
country: United States
facility: As0008 018
state: Texas
city: Seattle
country: United States
facility: As0008 002
state: Washington
city: Dobrich
country: Bulgaria
facility: As0008 156
city: Plovdiv
country: Bulgaria
facility: As0008 151
city: Plovdiv
country: Bulgaria
facility: As0008 154
city: Plovdiv
country: Bulgaria
facility: As0008 155
city: Ruse
country: Bulgaria
facility: As0008 150
city: Quebec
country: Canada
facility: As0008 101
city: Victoria
country: Canada
facility: As0008 100
city: Winnipeg
country: Canada
facility: As0008 103
city: Brno
country: Czechia
facility: As0008 205
city: Hustopece
country: Czechia
facility: As0008 206
city: Olomouc
country: Czechia
facility: As0008 207
city: Pardubice
country: Czechia
facility: As0008 208
city: Praha 11
country: Czechia
facility: As0008 210
city: Praha 2
country: Czechia
facility: As0008 202
city: Praha 4
country: Czechia
facility: As0008 201
city: Praha 4
country: Czechia
facility: As0008 209
city: Praha
country: Czechia
facility: As0008 211
city: Zlín
country: Czechia
facility: As0008 203
city: Cologne
country: Germany
facility: As0008 302
city: Hamburg
country: Germany
facility: As0008 304
city: Hannover
country: Germany
facility: As0008 308
city: Herne
country: Germany
facility: As0008 303
city: Ratingen
country: Germany
facility: As0008 301
city: Budapest
country: Hungary
facility: As0008 400
city: Budapest
country: Hungary
facility: As0008 403
city: Debrecen
country: Hungary
facility: As0008 402
city: Veszprem
country: Hungary
facility: As0008 401
city: Bydgoszcz
country: Poland
facility: As0008 466
city: Elblag
country: Poland
facility: As0008 453
city: Elblag
country: Poland
facility: As0008 456
city: Krakow
country: Poland
facility: As0008 455
city: Lublin
country: Poland
facility: As0008 461
city: Nowa Sol
country: Poland
facility: As0008 467
city: Poznan
country: Poland
facility: As0008 451
city: Poznan
country: Poland
facility: As0008 462
city: Torun
country: Poland
facility: As0008 450
city: Warszawa
country: Poland
facility: As0008 454
city: Warszawa
country: Poland
facility: As0008 459
city: Wroclaw
country: Poland
facility: As0008 457
city: Wroclaw
country: Poland
facility: As0008 460
city: Wroclaw
country: Poland
facility: As0008 465
city: Moscow
country: Russian Federation
facility: As0008 601
city: Moscow
country: Russian Federation
facility: As0008 604
city: Moscow
country: Russian Federation
facility: As0008 605
city: Moscow
country: Russian Federation
facility: As0008 607
city: Saint Petersburg
country: Russian Federation
facility: As0008 600
city: Saint Petersburg
country: Russian Federation
facility: As0008 606
city: Saint Petersburg
country: Russian Federation
facility: As0008 608
city: Saint Petersburg
country: Russian Federation
facility: As0008 609
city: Saint Petersburg
country: Russian Federation
facility: As0008 610
city: Cordoba
country: Spain
facility: As0008 800
city: La Coruna
country: Spain
facility: As0008 801
city: Santiago de Compostela
country: Spain
facility: As0008 803
city: Kiev
country: Ukraine
facility: As0008 700
city: Kyiv
country: Ukraine
facility: As0008 707
city: Ternopil
country: Ukraine
facility: As0008 705
city: Uzhgorod
country: Ukraine
facility: As0008 708
city: Vinnytsya
country: Ukraine
facility: As0008 706
city: Zaporizhya
country: Ukraine
facility: As0008 704
Study officials:
affiliation: +1 844 599 2273(UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: van der Heijde D, Gensler LS, Deodhar A, Baraliakos X, Poddubnyy D, Kivitz A, Farmer MK, Baeten D, Goldammer N, Coarse J, Oortgiesen M, Dougados M. Dual neutralisation of interleukin-17A and interleukin-17F with bimekizumab in patients with active ankylosing spondylitis: results from a 48-week phase IIb, randomised, double-blind, placebo-controlled, dose-ranging study. Ann Rheum Dis. 2020 May;79(5):595-604. doi: 10.1136/annrheumdis-2020-216980. Epub 2020 Apr 6.
citation: Robinson PC, Machado PM, Haroon N, Gensler LS, Reveille JD, Taieb V, Vaux T, Fleurinck C, Oortgiesen M, de Peyrecave N, Deodhar A. Minimal Impact of the COVID-19 Pandemic on Disease Activity and Health-Related Quality of Life in Patients With Ankylosing Spondylitis Receiving Bimekizumab: Exploratory Analyses From a Phase 2b Open-Label Extension Study. ACR Open Rheumatol. 2022 Sep;4(9):819-824. doi: 10.1002/acr2.11486. Epub 2022 Jul 14.