A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02963506
• Date of registration: 10/11/2016
• Prospective Registration: No
• Primary sponsor: UCB Biopharma S.P.R.L.
• Public title: A Study to Evaluate the Efficacy and Safety of Different Doses of Bimekizumab in Subjects With Active Ankylosing Spondylitis BE AGILE
• Scientific 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
• Date of first enrolment: October 2016
• Target sample size: 303
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02963506
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Canada, Czech Republic, Czechia, Germany, Hungary, Poland, Russian Federation, Spain, Ukraine, United States

Contacts

• Name: UCB Cares
• Affiliation: [phone](UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: Bimekizumab

Other: Placebo

Primary Outcome(s)

Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Percentage of Participants With Axial Spondyloarthritis International Society (ASAS) 5/6 Response at Week 12 [Time Frame: Week 12]

Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12 [Time Frame: Week 12]

Percentage of Participants With at Least One Adverse Event (AE) During the Study [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)]

Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: From Baseline to Week 12]

Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: From Baseline to Week 12]

Percentage of Participants Who Withdrew Due to an Adverse Event (AE) During the Study [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)]

Percentage of Participants With at Least One Serious Adverse Event (SAE) During the Study [Time Frame: From Screening until Safety Follow-Up Visit (up to Week 77)]

Change From Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12 [Time Frame: From Baseline to Week 12]

Secondary ID(s)

2016-001102-42

AS0008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02963506