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New drug shows promise for back pain from ankylosing spondylitis

NCT ID NCT03928743

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a drug called bimekizumab in 332 adults with active ankylosing spondylitis, a type of arthritis that causes back pain and stiffness. Participants received either the drug or a placebo injection. The goal was to see if the drug could reduce symptoms like pain and inflammation. Results showed that more people on bimekizumab had significant improvement at 16 weeks compared to placebo.

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

332 people

The number who actually took part.

Started

Apr 2019

Finished

Aug 2022

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 * Subject has ankylosing spondylitis (AS) as per the Modified New York (mNY) criteria with documented radiologic evidence, and at least 3 months of symptoms with age at symptom onset less than 45 years * Subjects has moderate-to-severe active disease defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) \>=4 AND spinal pain \>=4 on a 0 to 10 Numeric Rating Scale * 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: * Total ankylosis of the spine * 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 at any time are excluded * 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 AxSpA, eg, rheumatoid 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.

ankylosing spondylitis Axial Spondyloarthritis

As listed by the trial registrant

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

Ankylosing spondylitis

Contacts and locations

Locations

  • As0011 20018

    Shanghai, China

  • As0011 20019

    Guangzhou, China

  • As0011 20020

    Shanghai, China

  • As0011 20021

    Chengdu, China

  • As0011 20024

    Nanjing, China

  • As0011 20025

    Wenzhou, China

  • As0011 20026

    Shanghai, China

  • As0011 20030

    Chūōku, Japan

  • As0011 20031

    Sapporo, Japan

  • As0011 20032

    Suita, Japan

  • As0011 20034

    Hefei, China

  • As0011 20035

    Tokyo, Japan

  • As0011 20037

    Osaka, Japan

  • As0011 20040

    Beijing, China

  • As0011 20042

    Sasebo, Japan

  • As0011 20045

    Kita-gun, Japan

  • As0011 20047

    Himeji-shi, Japan

  • As0011 20048

    Saitama, Japan

  • As0011 20065

    Kitakyushu, Japan

  • As0011 20084

    Saga, Japan

  • As0011 40001

    Ghent, Belgium

  • As0011 40003

    Genk, Belgium

  • As0011 40004

    Brussels, Belgium

  • As0011 40005

    Sofia, Bulgaria

  • As0011 40006

    Plovdiv, Bulgaria

  • As0011 40007

    Plovdiv, Bulgaria

  • As0011 40008

    Sofia, Bulgaria

  • As0011 40009

    Pardubice, Czechia

  • As0011 40010

    Uherské Hradiště, Czechia

  • As0011 40011

    Brno, Czechia

  • As0011 40012

    Zlín, Czechia

  • As0011 40013

    Prague, Czechia

  • As0011 40014

    Prague, Czechia

  • As0011 40015

    Prague, Czechia

  • As0011 40016

    Prague, Czechia

  • As0011 40018

    Boulogne-Billancourt, France

  • As0011 40022

    Limoges, France

  • As0011 40024

    Hanover, Germany

  • As0011 40025

    Berlin, Germany

  • As0011 40026

    Ratingen, Germany

  • As0011 40027

    Herne, Germany

  • As0011 40028

    Berlin, Germany

  • As0011 40029

    Hamburg, Germany

  • As0011 40031

    Szeged, Hungary

  • As0011 40032

    Debrecen, Hungary

  • As0011 40033

    Székesfehérvár, Hungary

  • As0011 40034

    Amsterdam, Netherlands

  • As0011 40037

    Lublin, Poland

  • As0011 40038

    Elblag, Poland

  • As0011 40039

    Wroclaw, Poland

  • As0011 40040

    Torun, Poland

  • As0011 40041

    Warsaw, Poland

  • As0011 40042

    Krakow, Poland

  • As0011 40043

    Wroclaw, Poland

  • As0011 40044

    Poznan, Poland

  • As0011 40045

    A Coruña, Spain

  • As0011 40046

    Córdoba, Spain

  • As0011 40047

    Madrid, Spain

  • As0011 40048

    Santiago de Compostela, Spain

  • As0011 40049

    Seville, Spain

  • As0011 40050

    Istanbul, Turkey (Türkiye)

  • As0011 40052

    Ankara, Turkey (Türkiye)

  • As0011 40053

    Ankara, Turkey (Türkiye)

  • As0011 40054

    London, United Kingdom

  • As0011 40055

    Norwich, United Kingdom

  • As0011 40056

    Leeds, United Kingdom

  • As0011 40057

    Edinburgh, United Kingdom

  • As0011 40078

    Leipzig, Germany

  • As0011 40080

    Szombathely, Hungary

  • As0011 50001

    Jackson, Tennessee, 38305, United States

  • As0011 50012

    Memphis, Tennessee, 38119, United States

  • As0011 50015

    Hagerstown, Maryland, 21740, United States

  • As0011 50016

    St Louis, Missouri, 63141, United States

  • As0011 50020

    Duncansville, Pennsylvania, 16635, United States

  • As0011 50036

    Mesquite, Texas, 75150, United States

  • As0011 50052

    Phoenix, Arizona, 85032, United States

  • As0011 50054

    Oklahoma City, Oklahoma, 73103, United States

  • As0011 50056

    Sarasota, Florida, 34239, United States

  • As0011 50057

    Dallas, Texas, 75231, United States

  • As0011 50058

    Phoenix, Arizona, 85037, United States

  • As0011 50060

    Upland, California, 91786, United States

  • As0011 50062

    Sun City, Arizona, 85351, United States

  • As0011 50131

    Mesa, Arizona, 85210, United States

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