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New drug shows promise for Long-Term control of back pain condition

NCT ID NCT04436640

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study is testing the long-term safety and effectiveness of bimekizumab, a drug that reduces inflammation, in 508 adults with active axial spondyloarthritis (including ankylosing spondylitis). Participants who completed earlier trials will receive the drug for an extended period. The main goal is to track side effects and see if the drug continues to control 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 drug that targets inflammation)
What this could lead to
If successful, this could confirm bimekizumab as a safe, long-term treatment option to control symptoms and slow disease progression in people with axial spondyloarthritis.
What could go wrong
This is an open-label extension study, meaning everyone knows they are getting the drug, which can bias results. Long-term side effects are still being monitored, and the drug may not work for everyone.

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

508 people

The number who actually took part.

Started

Jun 2020

Finished

Aug 2026

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: * 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) 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

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis Axial Spondyloarthritis Non-Radiographic Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

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

Contacts and locations

Locations

  • As0014 20018

    Shanghai, China

  • As0014 20019

    Guangzhou, China

  • As0014 20020

    Shanghai, China

  • As0014 20021

    Chengdu, China

  • As0014 20024

    Nanjing, China

  • As0014 20025

    Wenzhou, China

  • As0014 20026

    Shanghai, China

  • As0014 20030

    Chūōku, Japan

  • As0014 20031

    Sapporo, Japan

  • As0014 20032

    Suita, Japan

  • As0014 20034

    Hefei, China

  • As0014 20035

    Bunkyō City, Japan

  • As0014 20036

    Kawachi-Nagano, Japan

  • As0014 20037

    Osaka, Japan

  • As0014 20039

    Iruma-gun, Japan

  • As0014 20040

    Beijing, China

  • As0014 20045

    Kita-gun, Japan

  • As0014 20048

    Saitama, Japan

  • As0014 20065

    Kitakyushu, Japan

  • As0014 20084

    Saga, Japan

  • As0014 40001

    Ghent, Belgium

  • As0014 40003

    Genk, Belgium

  • As0014 40004

    Brussels, Belgium

  • As0014 40005

    Sofia, Bulgaria

  • As0014 40006

    Plovdiv, Bulgaria

  • As0014 40007

    Plovdiv, Bulgaria

  • As0014 40008

    Sofia, Bulgaria

  • As0014 40009

    Pardubice, Czechia

  • As0014 40010

    Uherské Hradiště, Czechia

  • As0014 40011

    Brno, Czechia

  • As0014 40012

    Zlín, Czechia

  • As0014 40013

    Prague, Czechia

  • As0014 40014

    Prague, Czechia

  • As0014 40015

    Prague, Czechia

  • As0014 40016

    Prague, Czechia

  • As0014 40018

    Boulogne-Billancourt, France

  • As0014 40022

    Limoges, France

  • As0014 40024

    Hanover, Germany

  • As0014 40025

    Berlin, Germany

  • As0014 40026

    Ratingen, Germany

  • As0014 40027

    Herne, Germany

  • As0014 40029

    Hamburg, Germany

  • As0014 40031

    Szeged, Hungary

  • As0014 40032

    Debrecen, Hungary

  • As0014 40033

    Székesfehérvár, Hungary

  • As0014 40034

    Amsterdam, Netherlands

  • As0014 40037

    Lublin, Poland

  • As0014 40038

    Elblag, Poland

  • As0014 40039

    Wroclaw, Poland

  • As0014 40040

    Torun, Poland

  • As0014 40041

    Warsaw, Poland

  • As0014 40042

    Krakow, Poland

  • As0014 40043

    Wroclaw, Poland

  • As0014 40044

    Poznan, Poland

  • As0014 40045

    A Coruña, Spain

  • As0014 40046

    Córdoba, Spain

  • As0014 40048

    Santiago de Compostela, Spain

  • As0014 40049

    Seville, Spain

  • As0014 40050

    Istanbul, Turkey (Türkiye)

  • As0014 40052

    Ankara, Turkey (Türkiye)

  • As0014 40053

    Ankara, Turkey (Türkiye)

  • As0014 40055

    Norwich, United Kingdom

  • As0014 40056

    Leeds, United Kingdom

  • As0014 40057

    Edinburgh, United Kingdom

  • As0014 40078

    Leipzig, Germany

  • As0014 50015

    Hagerstown, Maryland, 21740, United States

  • As0014 50016

    St Louis, Missouri, 63141, United States

  • As0014 50020

    Duncansville, Pennsylvania, 16635, United States

  • As0014 50052

    Phoenix, Arizona, 85032, United States

  • As0014 50055

    Portland, Oregon, 97239, United States

  • As0014 50056

    Sarasota, Florida, 34239, United States

  • As0014 50057

    Dallas, Texas, 75231, United States

  • As0014 50059

    Ormond Beach, Florida, 32174, United States

  • As0014 50060

    Upland, California, 91786, United States

  • As0014 50062

    Glendale, Arizona, 85306, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.