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New hope for hidden arthritis: drug trial targets pain without X-Ray signs

NCT ID NCT07339566

Disease control Sponsor: Lingli Dong 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a drug called xeligekimab in 40 adults with non-radiographic axial spondyloarthritis, a form of arthritis that causes back pain but doesn't appear on X-rays. Participants receive six injections over 12 weeks, and doctors check if symptoms improve by at least 20%. After 12 weeks, patients may continue the drug but must pay for it themselves. The goal is to control disease activity, not cure it.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 aged 18 years or older; * Diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria for axial spondyloarthritis; * Ineffective or intolerant to NSAID therapy; * Objective signs of inflammation (abnormal MRI or C-reactive protein); * Active axial spondyloarthritis with BASDAI score ≥4 and BASDAI question 2 ≥4; * Visual Analogue Scale (VAS) score ≥4; Exclusion Criteria: * Patients with radiographic evidence of sacroiliitis, bilateral ≥grade 2 or unilateral ≥grade 3; * Presence of other active inflammations besides axial spondyloarthritis (e.g., active inflammatory bowel disease \[IBD\] or uveitis); * Chest X-ray suggesting active infection or malignant lesions; * Active systemic infection within 2 weeks prior to enrollment; * Known tuberculosis, HIV, hepatitis B, or hepatitis C infection at screening; * History of lymphoproliferative disease, any history of malignancy (within the past 5 years); * Subjects with unstable cardiovascular disease; * Patients taking potent opioid analgesics; * Pregnant or lactating women.

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Conditions

The condition(s) this trial relates to.

Non-Radiographic Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

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

Non-radiographical axial spondyloarthritis NR-axial spondyloarthritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei, 430000, China