A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects With Active Nonradiographic Axial Spondyloarthritis

Conditions

• Nonradiographic Axial Spondyloarthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bimekizumab — DRUG
  Subjects will receive bimekizumab at pre-specified time-points.
• Placebo — OTHER
  Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.

Study Details

The purpose of the study is to demonstrate the efficacy, safety and tolerability of bimekizumab administered subcutaneously (sc) compared to placebo in the treatment of subjects with active nonradiographic axial spondyloarthritis (nr-axSpA).

Key Dates

Start date

Apr 25, 2019

Status verified

Dec 2025

Primary completion

Jun 29, 2022

Completion

Apr 17, 2023

Study Design

Enrollment

274 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Bimekizumab
  Subjects randomized to this arm will receive bimekizumab during the Double-Blind Treatment Period and the Maintenance Period.
• Placebo Comparator: Placebo
  Subjects randomized to this arm will receive placebo during the Double-Blind Treatment Period and receive bimekizumab during the Maintenance Period.

Primary Outcome Measure

Percentage of Participants With Assessment of SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 16 [ Time Frame: Week 16 ]

Locations (14)

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