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Hope for rare bone and skin condition: new drug trial launches

NCT ID NCT06011889

Symptom relief Sponsor: National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether etanercept, a drug that blocks inflammation, can reduce pain and disease activity in adults with SAPHO syndrome—a rare condition affecting bones, joints, and skin. Participants must have tried standard treatments like NSAIDs without enough relief. The trial compares etanercept to a placebo over 12 weeks to see if it improves symptoms.

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 60 people

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

Started

Sep 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

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: 1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003. 2. Age over 18. 3. Patient overall disease and pain assessment on VAS both ≥ 4 cm. 4. Expressing informed consent to participate in the study. Exclusion Criteria: 1. According to the Summary of Product Characteristics (SmPC) for Enbrel. 2. Pregnancy, breastfeeding, inability to use effective contraception during the examination. 3. Change in the dose of NSAIDs treatment in the last 4 weeks. 4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12 weeks. 5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks. 6. Use of corticosteroids (orally or local injections), bisphosphonates and/or antibiotics in the last 4 weeks. 7. Any medical condition that the investigator judges to contraindicate etanercept treatment.

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Conditions

The condition(s) this trial relates to.

SAPHO syndrome

As listed by the trial registrant

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

Sapho syndrome

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

  • Centrum Wsparcia Badań Klinicznych

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-637, Poland

More trials for these conditions

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