Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug aims to stop extra bone formation in rare disease

NCT ID NCT05090891

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tests an experimental drug called INCB000928 (zilurgisertib) in people with fibrodysplasia ossificans progressiva (FOP), a rare genetic condition where soft tissues turn into bone. About 98 participants aged 2 and older will receive either the drug or a placebo daily for several months. The main goal is to see if the drug reduces new abnormal bone growth, which could help control the disease and maintain mobility.

What this could mean

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

Active substance
INCB000928 (zilurgisertib)
What this could lead to
If successful, this drug could slow or prevent the formation of extra bone in people with FOP, potentially reducing disability and improving quality of life.
What could go wrong
This is an early Phase 2 trial with a small number of participants. The drug may not work better than placebo, and side effects are still being studied.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 98 people

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

Started

May 2022

Expected to finish

Jan 2033

An estimate. End dates often move.

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

2 to 99 years

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: * Female and male participants: * Cohort 1: ≥ 12 years of age. * Cohort 2: 6 to \< 12 years of age. * Cohort 3: 2 to \< 12 years of age (after eDMC review of safety data from Cohort 2). * Clinical diagnosis of FOP. * Willingness to avoid pregnancy or fathering children based on the criteria below. * Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation. * Further inclusion criteria apply. Exclusion Criteria: * Pregnant or breast-feeding. * CAJIS score ≥ 24. * FOP disease severity that in the investigator's opinion precludes participation. * Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data. * Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment. * HIV, HBV, or HCV infection. Note: * Further exclusion criteria apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Fibrodysplasia ossificans progressiva (FOP) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites in 6 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Albert Einstein Israelite Hospital

    ACTIVE_NOT_RECRUITING

    São Paulo, 05652-900, Brazil

  • Amsterdam Umc - Vu Medisch Centrum (Vumc)

    RECRUITING

    Amsterdam, 1081 HV, Netherlands

  • Ap-Hp Hopital Lariboisiere

    RECRUITING

    Paris, 75010, France

  • Beijing Childrens Hospital Capital Medical University

    RECRUITING

    Beijing, 100045, China

  • Centro de Estudios Reumatologicos

    ACTIVE_NOT_RECRUITING

    Santiago, 7501126, Chile

  • Children'S Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Childrens Hospital of Fudan University

    RECRUITING

    Shanghai, 201102, China

  • Groote Schuur Hospital Radiation Oncology

    ACTIVE_NOT_RECRUITING

    Cape Town, 07925, South Africa

  • Hopital Necker-Enfants Malades

    RECRUITING

    Paris, 75015, France

  • Hospital Italiano de Buenos Aires

    ACTIVE_NOT_RECRUITING

    Buenos Aires, CO 1181, Argentina

  • Hospital Universitario Ramon Y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra

    ACTIVE_NOT_RECRUITING

    Tlalpan, 14389, Mexico

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Murdoch Children'S Research Institute

    ACTIVE_NOT_RECRUITING

    Parkville, Victoria, 03052, Australia

  • Penn Medicine - Perelman Center For Advanced Medicine

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore

    ACTIVE_NOT_RECRUITING

    Rome, 00168, Italy

  • Royal National Orthopaedic Hospital

    ACTIVE_NOT_RECRUITING

    Stanmore, HA7 4LP, United Kingdom

  • Royal North Shore Hospital

    COMPLETED

    St Leonards, New South Wales, 02065, Australia

  • Seoul National University Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, 03080, South Korea

  • Shanghai Childrens Medical Center

    RECRUITING

    Shanghai, 200127, China

  • Starship Childrens Hospital

    ACTIVE_NOT_RECRUITING

    Auckland, 01023, New Zealand

  • Tongji Hospital of Tongji University

    RECRUITING

    Shanghai, 200065, China

  • Uniklinik Koln

    RECRUITING

    Cologne, 50931, Germany

  • University Health Network Toronto General Hospital

    ACTIVE_NOT_RECRUITING

    Toronto, Ontario, M5G 2N2, Canada

More trials for these conditions

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