An extension study to learn if Bimekizumab works and is safe over a long period in adults with Active Axial Spondyloarthritis.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

29 Jun 2020 → 2 Oct 2025

Decision date (initial)

2024-07-03

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

UCB Biopharma SRL

External identifiers

EU CT number

2023-506527-28-00

EudraCT number

2019-004163-47

WHO UTN

U1111-1304-6865

ClinicalTrials.gov

NCT04436640

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy, Pharmacokinetic, Therapy

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

Secondary objectives 1

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

Conditions and MedDRA coding

Axial Spondyloarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • 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)

Exclusion criteria 1

1. • 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 36

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 13

Locations

7 EU/EEA countries · 30 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 52 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications