A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.

• Register: EUCTR
• Last refreshed on: 15 October 2018
• Main ID: EUCTR2016-001102-42-HU
• Date of registration: 28/09/2016
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SPRL
• Public title: A Multicenter study to evaluate the efficacy and safety of different doses of bimekizumab in subjects with active Ankylosing Spondylitis which is a form of arthritis that primarily affects the spine.
• 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: 21/11/2016
• Target sample size: 285
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001102-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 5
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

• Name: Clin Trial Reg & Results Disclosure
• Affiliation: UCB BIOSCIENCES GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Subject has active 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:
--BASDAI score >=4
--Spinal pain >=4 on a 0 to 10 NRS (from BASDAI item 2)
- Subjects must have at least 1 of the following:
-- inadequate response to nonsteroidal anti-inflammatory drug (NSAID) therapy
-- intolerance to administration of at least 1 NSAID
-- 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 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 TNF inhibitor-naïve or may have received 1 prior TNF inhibitor. Subjects who have been on a TNF inhibitor previously must have:
--experienced an inadequate response to previous treatment given for at least 3 months
-- been intolerant to administration (eg, had a side effect/AE that led to discontinuation)
-- lost access to TNF inhibitor for other reasons
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
- Subjects with a total ankylosis of the spine, or a diagnosis of any other inflammatory arthritis eg,rheumatoid arhritis (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 tubercolosis (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 indlucded:
a) <= 3 excised or ablated basal cell carcinomas of the skin
b) 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
c) Actinic keratosis (-es)
d) Squamous cell carcinoma-in-situ of the skin successfully excised, or ablated, more than 6 months prior to Screening


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis
MedDRA version: 19.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Product Name: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bimekizumab
CAS Number: 1418205-77-2
Current Sponsor code: UCB4940
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 160-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Assess the dose-response based on the efficacy of bimekizumab

Primary end point(s): Subjects with Axial Spondyloarthritis International Society 40 % response criteria (ASAS40) at Week 12

Secondary Objective: - assess the efficacy of the individual dose regimens of bimekizumab compared to placebo
- assess the safety and tolerability of bimekizumab
- assess the pharmacokinetics (PK) of bimekizumab
- assess the pharmacodynamics (PD) of bimekizumab
- assess the immunogenicity of bimekizumab
- assess the exposure: response relationship of bimekizumab as it relates to efficacy and safety

Timepoint(s) of evaluation of this end point: Week 12

Secondary Outcome(s)

Secondary end point(s): - Change from Baseline in Ankylosing Spondylitis Disease Activity Score - C-Reactive Protein (ASDAS [CRP]) at Week 12
- Subjects with Axial Spondyloarthritis International Society 20 % response criteria (ASAS20) at Week 12
- Subjects with Axial Spondyloarthritis International Society (ASAS) 5/6 response at Week 12
- Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
- Change from Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)

Timepoint(s) of evaluation of this end point: Baseline
Week 12

Secondary ID(s)

AS0008

Source(s) of Monetary Support

UCB Biopharma SPRL