Clinical trial NCT03215277: A Study to Test the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Patients With Active Ankylosing Spondylitis
Official title: A Multicenter, Phase 2A, Randomized, Investigator-Blind, Subject-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab and Certolizumab Pegol in Subjects With Active Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Spondylitis
Bimekizumab
AS
Certolizumab Pegol
Cimzia
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2017-07-12
Enrollment: 76
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 purpose of the study is to evaluate the efficacy and safety of bimekizumab compared to certolizumab pegol in the treatment of subjects with active ankylosing spondylitis (AS).


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of active adult-onset ankylosing spondylitis (AS) as defined by documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984) of at least 3 months' symptom duration and age of onset \<45 years
* Subject has moderate to severe active disease at the Screening Visit as defined by each of the following:

  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score \>=4
  2. Spinal pain \>=4 on a 0 to 10 numeric rating scale (NRS) (from BASDAI Item 2)
* Subjects must have had an inadequate response to, have a contraindication to, or have been intolerant to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs)
* Subjects taking corticosteroids must be on a maximum daily dose of \<=10mg/day oral prednisolone or equivalent
* Subjects taking methotrexate (MTX; \<=25 mg/week) are allowed to continue their medication if they received a stable dose for at least 12 weeks before randomization
* Subjects taking sulfasalazine (up to 3 grams/day) or hydroxychloroquine (up to 400 mg per day total) are allowed to continue their medication if started at least 12 weeks prior to randomization
* Subject who has been on an anti-tumor necrosis factor alpha (TNFα) agent must have experienced an inadequate response to previous or current treatment given at an approved dose for at least 3 months or have been intolerant to at least 1 administration of an anti-TNFα agent. Subjects may not have been on more than 1 anti-TNFα agent
* Subject has high-sensitive C-Reactive Protein (hsCRP) levels \>=3 mg/L at the Screening Visit
* 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 investigational medicinal product (IMP)
* Male subjects with a partner of childbearing potential must be willing to use a condom when sexually active, up till 20 weeks after the last administration of IMP

Exclusion Criteria:

* Subject has received previous or current biological treatment other than TNFα inhibitor treatment
* 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)
* Subject has received previous or current biological treatment other than TNFα inhibitor treatment
* Subject has chronic, recurrent, recent serious / life-threatening or current infection, as defined in the protocol
* Subject has history of certain atypical infections, viral hepatitides, human immunodeficiency virus (HIV) infection, tuberculosis, as defined in the protocol
* 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
* Subject has immunosuppressive condition or treatment, recent history of malignancy (some exceptions) or demyelinating disease
* 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
* Subject has history of psychiatric disorder, including suicidality (as defined in the protocol
* Subject has major abnormalities on laboratory testing, as defined in the protocol

Primary outcomes:
measure: Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12
timeFrame: From Baseline to Week 12
measure: Number of Participants With Adverse Events (AE) During the Study Conduct
timeFrame: From Baseline until Safety Follow-Up Visit (up to Week 64)
measure: Number of Participants With Serious Adverse Events (SAEs) During the Study Conduct
timeFrame: From Baseline until Safety Follow-Up Visit (up to Week 64)
measure: Number of Participants Who Withdrew Due to an Adverse Event (AE) During the Study Conduct
timeFrame: From Baseline until Safety Follow-Up Visit (up to Week 64)
Secondary outcomes:
measure: Number of Participants With Ankylosing Spondylitis Disease Activity Score - Inactive Disease (ASDAS-ID) at Week 12
timeFrame: Week 12
measure: Number of Participants With Ankylosing Spondylitis Disease Activity Score-Major Improvement (ASDAS-MI) at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Ormond Beach
country: United States
facility: As0013 908
state: Florida
city: Lincoln
country: United States
facility: As0013 903
state: Nebraska
city: Oklahoma City
country: United States
facility: As0013 902
state: Oklahoma
city: Memphis
country: United States
facility: As0013 906
state: Tennessee
city: Kladno
country: Czechia
facility: As0013 202
city: Ostrava
country: Czechia
facility: As0013 205
city: Praha 2
country: Czechia
facility: As0013 201
city: Praha 3
country: Czechia
facility: As0013 203
city: Berlin
country: Germany
facility: As0013 302
city: Berlin
country: Germany
facility: As0013 306
city: Erlangen
country: Germany
facility: As0013 304
city: Hamburg
country: Germany
facility: As0013 303
city: Herne
country: Germany
facility: As0013 301
city: Athens
country: Greece
facility: As0013 405
city: Heraklion
country: Greece
facility: As0013 404
city: Patra
country: Greece
facility: As0013 401
city: Thessaloníki
country: Greece
facility: As0013 402
city: Thessaloníki
country: Greece
facility: As0013 406
city: Chisinau
country: Moldova, Republic of
facility: As0013 501
city: Amsterdam
country: Netherlands
facility: As0013 601
city: Białystok
country: Poland
facility: As0013 708
city: Kraków
country: Poland
facility: As0013 709
city: Olsztyn
country: Poland
facility: As0013 706
city: Poznań
country: Poland
facility: As0013 703
city: Toruń
country: Poland
facility: As0013 702
city: Warsaw
country: Poland
facility: As0013 701
city: Warszawa
country: Poland
facility: As0013 704
city: Wrocław
country: Poland
facility: As0013 707
city: Kazan
country: Russian Federation
facility: As0013 801
city: Kemerovo
country: Russian Federation
facility: As0013 803
city: Moscow
country: Russian Federation
facility: As0013 806
city: Moscow
country: Russian Federation
facility: As0013 807
city: Yaroslavl
country: Russian Federation
facility: As0013 802
city: Yaroslavl
country: Russian Federation
facility: As0013 805
Study officials:
affiliation: +1-844-599-2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References: