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

Phase 1

• Conditions: Axial Spondyloarthritis; MedDRA version: 21.1Level: PTClassification code 10071400Term: Axial spondyloarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2019-004163-47-HU
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 485

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the long-term safety and tolerability of bimekizumab in patients with active axial spondyloarthritis<br>;Secondary Objective: Assess the impact of bimekizumab on:<br>- Long-term efficacy<br>- Patient-reported outcomes including health-related quality of life<br>- Spinal mobility<br>- Enthesitis and peripheral arthritis<br>;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study<br>2. Incidence of serious adverse events (SAEs) during the study<br>3. Treatment-emergent adverse events (TEAEs) leading to withdrawal from the study<br>;Timepoint(s) of evaluation of this end point: From Baseline (Day 1) until Safety Follow-Up (up to Week 128)<br>