A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO ASSESS 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

Phase 3

• Conditions: Axial spondyloarthritis - Bechterew's disease; 10003816

• Registration Number: NL-OMON55001
• Lead Sponsor: CB Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 8

Inclusion Criteria

To be eligible to participate in this study, all of the following criteria must
be met:
1. An Institutional Review Board/Independent Ethics Committee approved written
Informed Consent Form is signed and dated by the study participant.
2. 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.
3. In the opinion of the Investigator, the study participant is expected to
benefit from participation in this OLE study.
4. Study participant completed AS0010 or AS0011 without meeting any withdrawal
criteria.
5. Female study participants must be:
* postmenopausal (at least 1 year),
* permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral
salpingectomy),
* or, if of childbearing potential (and engaged in sexual activity that could
result in procreation), must be willing to use a highly effective method of
contraception until 20 weeks after last administration of IMP, and have a
negative pregnancy test at the last visit of AS0010 or AS0011.
The following methods are considered highly effective when used consistently
and correctly:
* combined (estrogen and progestogen) hormonal contraception associated with
inhibition of ovulation (oral, intravaginal, or transdermal),
* progestogen-only hormonal contraception associated with inhibition of
ovulation (oral, injectable, or implantable),
* intrauterine device,
* intrauterine hormone-releasing system, and
* vasectomized partner
Abstinence as a form of birth control is generally not allowed in the study
unless abstinence is in accordance with a study participant*s preferred and
common lifestyle. Study personnel must confirm the continued use of abstinence
is still in accordance with the study participant*s lifestyle at regular
intervals during the study.

Exclusion Criteria

Study participants are not permitted to enroll in the study if any of the
following criterion is met:
1. Female study participants who plan to become pregnant during the study or
within 20 weeks following final dose of IMP. Male study participants who are
planning a partner pregnancy during the study or within 20 weeks following the
final dose.
2. 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.
3. Study participant has a positive or indeterminate interferon gamma release
assay in AS0010 or AS0011, unless appropriately evaluated and treated.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary safety variable:<br /><br>• Treatment-emergent adverse events (TEAEs)<br /><br>• SAEs<br /><br>• TEAEs leading to withdrawal from bimekizumab<br /><br><br /><br>Primary efficacy variable:<br /><br>Not applicable</p><br>