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

UCB Biopharma S.P.R.L.303 enrolled

Overview

This is a study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis (AS).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

303

Conditions

Ankylosing Spondylitis

Interventions

PlaceboOTHER

BimekizumabDRUG

Bimekizumab in different dosages.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (74)

Outcomes

Primary Outcomes

Percentage of Participants With Axial Spondyloarthritis International Society 40% Response Criteria (ASAS40) at Week 12

The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS score), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.

Time frame: Week 12

Secondary Outcomes

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

The ASDAS was calculated as the sum of the following components: 0.121 x Back pain (BASDAI question 2 result) 0.058 x Duration of morning stiffness (BASDAI question 6 result) 0.110 x PGADA 0.073 x Peripheral pain/swelling (BASDAI question 3 result) 0.579 x (natural logarithm of the (hs-CRP \[mg/L\] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue are all assessed on a numerical scale (0 to 10 units). The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening. There is a minimum score of 0.636 for the total ASDAS score, but no defined upper score since CRP does not have a set upper limit. If one component for the ASDAS-CRP was missing at a given visit, that component was imputed by carrying the last observation forward, and the ASDAS-CRP was calculated accordingly. If the hs-CRP value was below 2 mg/L, then it was imputed as the constant value of 2 mg/L.

Time frame: From Baseline to Week 12

Percentage of Participants With Axial Spondyloarthritis International Society 20% Response Criteria (ASAS20) at Week 12

The ASAS20 response was defined as an improvement of at least 20% and absolute improvement of at least 1 unit on a 0 to 10 NRS, where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: PGADA, Pain assessment (total spinal pain NRS scores), Function (BASFI), Inflammation (mean of BASDAI questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain \[deterioration was defined as a relative worsening of at least 20% and an absolute worsening of at least 1 unit\]. Note: Participants with missing data or who discontinue study treatment prior to Week 12 were counted as non-responders.

Data from ClinicalTrials.gov

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