A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis

• Register: EUCTR
• Last refreshed on: 4 April 2022
• Main ID: EUCTR2017-003065-95-HU
• Date of registration: 25/03/2019
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A study to evaluate the efficacy and safety of bimekizumab in subjects with active ankylosing spondylitis
• Scientific title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF BIMEKIZUMAB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS
• Date of first enrolment: 16/04/2019
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003065-95
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Bulgaria, China, Czech Republic, Czechia, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, 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:
-Male or female patients at least 18 years of age
-Subject has ankylosing spondylitis as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years
-Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >=4 AND spinal pain >=4 on a 0 to 10 Numeric Rating Scale
-Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy
-Patients must have inadequate response to NSAIDs, intolerance to administration of at least 1 NSAID, or contraindication(s) to NSAID therapy
-Patients who have taken a tumor necrosis factor alpha (TNFa) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks
-Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry


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 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion criteria:
-Total ankylosis of the spine
-Treatment with more than 1 TNFa inhibitor and/or more than 2 additional non-TNFa biological response modifiers, or any interleukin (IL)-17 biological response modifier at any time are excluded
-Active infection or history of recent serious infections
-Viral hepatitis B or C or human immunodeficiency virus (HIV) infection
-Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study
-Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection
-Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer
-Diagnosis of inflammatory conditions other than ankylosing spondylitis (AS), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study
-Presence of active suicidal ideation, or moderately severe major depression or severe major depression
-Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study
-Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening



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

Health Condition(s) or Problem(s) studied

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

Ankylosing spondylitis
MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Product Name: bimekizumab
Product Code: UCB4940
Pharmaceutical Form: Solution for injection in pre-filled syringe
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: Suspension for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Demonstrate the efficacy of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS)

Primary end point(s): Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 16

Secondary Objective: - Assess the efficacy of bimekizumab compared to placebo
- Assess the safety and tolerability of bimekizumab
- Assess the impact of bimekizumab on patient-reported quality of life
- Assess the impact of bimekizumab on spinal mobility
- Assess the impact of bimekizumab on enthesitis and on peripheral arthritis

Timepoint(s) of evaluation of this end point: Week 16

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1.; 2.; 4.-6. Week 16
7.-13. Baseline, Week 16
14.-16. From Baseline (Day 1) until Safety Follow-Up (up to Week 72)

Secondary end point(s): 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response in TNFa inhibitor-naïve subjects at Week 16
2. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 16
3. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score at Week 16
4. Assessment of SpondyloArthritis International Society (ASAS) partial remission (PR) at Week 16
5. Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) at Week 16
6. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 16
7. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 16
8. Change from Baseline in nocturnal spinal pain score Numeric Rating Scale (NRS) at Week 16
9. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) total score at Week 16
10. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 16
11. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 16
12. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
13. Enthesitis-free state based on the Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) Index in the subgroup of subjects with enthesitis at Baseline at Week 16
14. Incidence of treatment-emergent adverse events (TEAEs) during the study
15. Incidence of treatment-emergent serious adverse events (SAEs) during the study
16. Treatment-emergent adverse events (TEAEs) leading to withdrawal from investigational medicinal product (IMP) during the study

Secondary ID(s)

AS0011

2017-003065-95-DE

Source(s) of Monetary Support

UCB Biopharma SRL

Ethics review

Status: Approved
Approval date: 27/03/2019
Contact: