A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis

• Register: EUCTR
• Last refreshed on: 8 July 2024
• Main ID: EUCTR2019-004163-47-HU
• Date of registration: 01/04/2020
• Prospective Registration: Yes
• Primary sponsor: UCB Biopharma SRL
• Public title: A study to evaluate the long-term safety, tolerability and efficacy of bimekizumab in subjects with active axial spondyloarthritis including ankylosing spondylitis and nonradiographic axial spondyloarthritis
• Scientific title: A Multicenter, Open-Label Extension Study to Asses the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Study Participants With Active Axial Spondyloarthritis, Ankylosing Spondylitis, and Nonradiographic Axial Spondyloarthritis
• Date of first enrolment: 16/06/2020
• Target sample size: 485
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-004163-47
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• 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, France, Germany, Hungary, Japan, Netherlands, Poland, Spain, Turkey, United Kingdom, United States

Contacts

• Name: DDGS
• Affiliation: UCB Biosciences GmbH

• Name: DDGS
• Affiliation: UCB Biosciences GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
- Study participant is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgement of the Investigator
- In the opinion of the Investigator, the study participant is expected to benefit from participation in this extension study
- Study participant completed AS0010 (NCT03928704) or AS0011 (NCT03928743)

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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion criteria:
- Female study participants who plan to become pregnant during the study or within 20 weeks following final dose of Investigational Medicinal Product (IMP). Male study participants who are planning a partner pregnancy during the study or within 20 weeks following the final dose
- Study participants who meet any withdrawal criteria in AS0010 or AS0011. For any study participant with an ongoing serious adverse event (SAE), or a history of serious infections (including hospitalizations) in the feeder study, the Medical Monitor must be consulted prior to the study participant’s entry into AS0014
- Study participant has a positive or indeterminate interferon gamma release assay (IGRA) in AS0010 or AS0011, unless appropriately evaluated and treated



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

Health Condition(s) or Problem(s) studied

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

Axial Spondyloarthritis
MedDRA version: 21.1 Level: PT Classification code 10071400 Term: Axial spondyloarthritis 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-

Primary Outcome(s)

Secondary Objective: Assess the impact of bimekizumab on:
- Long-term efficacy
- Patient-reported outcomes including health-related quality of life
- Spinal mobility
- Enthesitis and peripheral arthritis

Timepoint(s) of evaluation of this end point: From Baseline (Day 1) until Safety Follow-Up (up to Week 128)

Main Objective: Assess the long-term safety and tolerability of bimekizumab in patients with active axial spondyloarthritis

Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study
2. Incidence of serious adverse events (SAEs) during the study
3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 1, 4, 10, 13, 16: Week 28
2, 5, 11, 14, 17: Week 52
3, 6, 12, 15, 18: Week 112
7, 19, 22, 25, 28, 31, 34: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 28
8, 20, 23, 26, 29, 32, 35: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 52
9, 21, 24, 27, 30, 33, 36: Change from Baseline of AS0010 (NCT03928704) or AS0011 (NCT03928743) to Week 112

Secondary end point(s): 1. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 28
2. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 52
3. Assessment of SpondyloArthritis International Society 40% response criteria (ASAS40) response at Week 112
4. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 28
5. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 52
6. Assessment of SpondyloArthritis International Society 20% response criteria (ASAS20) response at Week 112
7. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 28
8. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52
9. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 112
10. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 28
11. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 52
12. Assessment of SpondyloArthritis International Society partial remission (ASAS-PR) at Week 112
13. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP) at Week 28
14. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)
at Week 52
15. Assessment of Ankylosing Spondylitis Disease Activity Score-C-reactive protein (ASDAS-CRP)
at Week 112
16. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 28
17. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 52
18. Assessment of SpondyloArthritis International Society (ASAS) 5/6 response at Week 112
19. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 28
20. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52
21. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 112
22. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 28
23. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 52
24. Change from Baseline in Nocturnal Spinal Pain Numeric Rating Scale (NRS) at Week 112
25. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 28
26. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
27. Change from Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 112
28. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 28
29. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 52
30. Change from Baseline in the Short Form 36-Item Health Survey (SF-36) physical component summary (PCS) at Week 112
31. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 28
32. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 52
33. Change from Baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at Week 112
34. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 28
35. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 52
36. Change from Baseline in the Maastricht Ankylosing Spondylitis Enthesitis (MASES) Index at Week 112

Secondary ID(s)

AS0014

Source(s) of Monetary Support

UCB Biopharma SRL

Ethics review

Status: Approved
Approval date: 12/05/2020
Contact: