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New biologic drug aims to ease pain in hidden arthritis

NCT ID NCT03928704

Disease control Sponsor: UCB Biopharma SRL Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested the drug bimekizumab against a placebo in 274 adults with active nonradiographic axial spondyloarthritis, a form of arthritis that causes back pain but doesn't appear on X-rays. Participants received injections of either the drug or a placebo over several weeks. The main goal was to see if bimekizumab could reduce disease activity and improve symptoms like pain and stiffness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bimekizumab (a biologic drug given as an injection)
What this could lead to
If it works, this could provide a new treatment option to reduce pain and improve function in people with this type of arthritis.
What could go wrong
This is a single phase 3 trial; results may not confirm benefit or may show side effects. The drug is not yet approved for this condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

274 people

The number who actually took part.

Started

Apr 2019

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female patients at least 18 years of age * Patient has nonradiographic axial spondyloarthritis (nr-axSpA) with all of the following criteria: 1. Adult-onset axial spondyloarthritis meeting Assessment of SpondyloArthritis International Society (ASAS) classification criteria 2. Inflammatory back pain for at least 3 months 3. Age at symptom onset of less than 45 years 4. NO sacroiliitis (in Anterior-Posterior pelvis or sacroiliac x-ray) * Active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale * Objective inflammation defined by sacroiliitis on magnetic resonance imaging and/or elevated C-reactive protein * Subjects had to have either failed to respond to 2 different nonsteroidal anti-inflammatory drugs (NSAIDs) given at the maximum tolerated dose for a total of 4 weeks or have a history of intolerance to or a contraindication to NSAID therapy * Patients who have taken a tumor necrosis factor alpha (TNFα) inhibitor must have experienced an inadequate response or intolerance to treatment given at an approved dose for at least 12 weeks * Patients currently taking NSAIDs, cyclooxygenase 2 (COX-2) inhibitors, analgesics, corticosteroids, methotrexate (MTX), leflunomide (LEF), sulfasalazine (SSZ), hydroxychloroquine (HCQ) AND/OR apremilast can be allowed if they fulfill specific requirements prior to study entry Exclusion Criteria: * Treatment with more than 1 TNFα inhibitor and/or more than 2 additional non-TNFα biological response modifiers, or any interleukin (IL)-17 biological response modifier * Active infection or history of recent serious infections * Viral hepatitis B or C or human immunodeficiency virus (HIV) infection * Any live (includes attenuated) vaccination within the 8 weeks prior to entering the study or TB (Bacillus Calmette-Guerin) vaccination within 1 year prior entering the study * Known tuberculosis (TB) infection, at high risk of acquiring TB infection, or current or history of nontuberculous mycobacterium (NTMB) infection * Subject has any active malignancy or history of malignancy within 5 years prior to the Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma or in situ cervical cancer * Diagnosis of inflammatory conditions other than axial spondyloarthritis (axSpA), including but not limited to psoriatic arthritis, rheumatoid arthritis, sarcoidosis, systemic lupus erythematosus, and reactive arthritis. Patients with a diagnosis of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease (IBD) are allowed as long as they have no active symptomatic disease when entering the study * Presence of active suicidal ideation, or moderately severe major depression or severe major depression * Female patients who are breastfeeding, pregnant, or planning to become pregnant during the study * Subject has a history of chronic alcohol or drug abuse within 6 months prior to Screening

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Conditions

The condition(s) this trial relates to.

Axial Spondyloarthritis Non-Radiographic Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nonradiographic axial spondyloarthritis

Contacts and locations

Locations

  • As0010 20018

    Shanghai, China

  • As0010 20019

    Guangzhou, China

  • As0010 20020

    Shanghai, China

  • As0010 20021

    Chengdu, China

  • As0010 20024

    Nanjing, China

  • As0010 20025

    Wenzhou, China

  • As0010 20026

    Shanghai, China

  • As0010 20030

    Chūōku, Japan

  • As0010 20031

    Sapporo, Japan

  • As0010 20034

    Hefei, China

  • As0010 20035

    Tokyo, Japan

  • As0010 20036

    Kawachi-Nagano, Japan

  • As0010 20037

    Osaka, Japan

  • As0010 20038

    Nankoku-shi, Japan

  • As0010 20039

    Iruma-gun, Japan

  • As0010 20040

    Beijing, China

  • As0010 20045

    Kita-gun, Japan

  • As0010 20048

    Saitama, Japan

  • As0010 20065

    Kitakyushu, Japan

  • As0010 20084

    Saga, Japan

  • As0010 40001

    Ghent, Belgium

  • As0010 40002

    Merksem, Belgium

  • As0010 40003

    Genk, Belgium

  • As0010 40004

    Brussels, Belgium

  • As0010 40005

    Sofia, Bulgaria

  • As0010 40006

    Plovdiv, Bulgaria

  • As0010 40007

    Plovdiv, Bulgaria

  • As0010 40008

    Sofia, Bulgaria

  • As0010 40009

    Pardubice, Czechia

  • As0010 40010

    Uherské Hradiště, Czechia

  • As0010 40011

    Brno, Czechia

  • As0010 40012

    Zlín, Czechia

  • As0010 40013

    Prague, Czechia

  • As0010 40014

    Prague, Czechia

  • As0010 40015

    Prague, Czechia

  • As0010 40016

    Prague, Czechia

  • As0010 40018

    Boulogne-Billancourt, France

  • As0010 40022

    Limoges, France

  • As0010 40024

    Hanover, Germany

  • As0010 40025

    Berlin, Germany

  • As0010 40026

    Ratingen, Germany

  • As0010 40027

    Herne, Germany

  • As0010 40029

    Hamburg, Germany

  • As0010 40031

    Szeged, Hungary

  • As0010 40032

    Debrecen, Hungary

  • As0010 40033

    Székesfehérvár, Hungary

  • As0010 40037

    Lublin, Poland

  • As0010 40038

    Elblag, Poland

  • As0010 40039

    Wroclaw, Poland

  • As0010 40040

    Torun, Poland

  • As0010 40041

    Warsaw, Poland

  • As0010 40042

    Krakow, Poland

  • As0010 40043

    Wroclaw, Poland

  • As0010 40044

    Poznan, Poland

  • As0010 40045

    A Coruña, Spain

  • As0010 40046

    Córdoba, Spain

  • As0010 40047

    Madrid, Spain

  • As0010 40048

    Santiago de Compostela, Spain

  • As0010 40049

    Seville, Spain

  • As0010 40050

    Istanbul, Turkey (Türkiye)

  • As0010 40051

    Izmir, Turkey (Türkiye)

  • As0010 40052

    Ankara, Turkey (Türkiye)

  • As0010 40053

    Ankara, Turkey (Türkiye)

  • As0010 40054

    London, United Kingdom

  • As0010 40055

    Norwich, United Kingdom

  • As0010 40056

    Leeds, United Kingdom

  • As0010 40057

    Edinburgh, United Kingdom

  • As0010 40078

    Leipzig, Germany

  • As0010 40080

    Szombathely, Hungary

  • As0010 50012

    Memphis, Tennessee, 38119-5214, United States

  • As0010 50015

    Hagerstown, Maryland, 21740, United States

  • As0010 50016

    St Louis, Missouri, 63141, United States

  • As0010 50020

    Duncansville, Pennsylvania, 16635, United States

  • As0010 50036

    Mesquite, Texas, 75150, United States

  • As0010 50052

    Phoenix, Arizona, 85032, United States

  • As0010 50055

    Portland, Oregon, 97239-3011, United States

  • As0010 50056

    Sarasota, Florida, 34239, United States

  • As0010 50057

    Dallas, Texas, 75231, United States

  • As0010 50059

    Ormond Beach, Florida, 32174, United States

  • As0010 50060

    Upland, California, 91786, United States

  • As0010 50061

    Spokane, Washington, 99204, United States

  • As0010 50062

    Sun City, Arizona, 85351, United States

  • As0010 50131

    Mesa, Arizona, 85210, United States