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Incb000928

Clinical trials are studying Incb000928 in people with fibrodysplasia ossificans progressiva, also called FOP. These studies aim to see whether it can help prevent new bone-forming lesions, and they also check safety and tolerability. The main trial listed is a Phase 2 study in adults or other eligible participants with FOP.

Table of Contents

Trial overview

The clinical trial listed for Incb000928 is PROGRESS, a Phase 2 study in people with Fibrodysplasia Ossificans Progressiva (FOP).[1] It is an interventional study, which means participants receive a study treatment rather than only being observed.[1]

The study is authorised and plans to enroll 60 participants.[1] Its brief purpose is to determine whether Incb000928 can help prevent new heterotopic ossification (HO) lesions in people with FOP.[1]

Study design and treatment groups

This trial is randomized, double-blind, and placebo-controlled.[1] Randomized means participants are assigned by chance to a study group, double-blind means neither participants nor the study team know who gets which treatment, and placebo-controlled means one group receives a placebo for comparison.[1]

The interventions listed are oral Incb000928 at 100 mg and placebo.[1] The trial record provided does not give more detail about visit schedules or how long treatment lasts beyond the main outcome time point.[1]

Who can participate

The target population is participants with Fibrodysplasia Ossificans Progressiva.[1] The provided trial data do not list extra eligibility rules such as age limits, disease stage, or prior treatment history.[1]

Because FOP is a rare condition, studies like this are usually small and focus on carefully selected participants who match the study criteria.[1] In this record, the total planned enrollment is 60 people.[1]

What researchers are measuring

The main primary outcome is the occurrence of new HO lesions measured by low-dose whole-body CT, excluding the head, from baseline to Week 24.[1] Baseline means the starting point before treatment begins.[1]

Low-dose whole-body CT is a scan that uses a lower amount of radiation to look for new bone lesions throughout the body.[1] This outcome is important because it helps researchers see whether the study treatment may prevent new unwanted bone formation.[1]

The trial summary also states that the study is evaluating efficacy, safety, and tolerability of Incb000928.[1] Efficacy means how well the treatment works, safety means whether medical problems happen, and tolerability means how well participants can take the treatment during the study.[1]

What the study may show

This trial is designed to learn whether Incb000928 can reduce or prevent new HO lesions in people with FOP.[1] If the results are positive, they may support further research in this rare disease.[1]

Because this is a Phase 2 study, the main focus is still early testing rather than final proof.[1] The study is meant to give a clearer idea of whether the treatment has promise and whether it can be studied further in larger trials.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05090891 Phase 2 Fibrodysplasia Ossificans Progressiva Authorised 60

FAQ

  • What is being studied in the Incb000928 trial? The trial is studying whether Incb000928 can help prevent new heterotopic ossification (HO) lesions. HO means bone forms in places where it should not, such as muscles or soft tissues.
  • Who can take part in the study? The study is for participants with fibrodysplasia ossificans progressiva, or FOP. The trial record does not list more detailed eligibility rules in the provided data.
  • What phase is the Incb000928 trial? The listed study is a Phase 2 trial. Phase 2 studies usually look at whether a treatment may work and continue to check safety.
  • What outcomes are the researchers measuring? The main outcome is the number of new HO lesions seen on low-dose whole-body CT, except for the head, from the start of the study to Week 24. This helps show whether new unwanted bone growth is being prevented.
  • Is the study comparing Incb000928 with another treatment? Yes. The study is randomized, double-blind, and placebo-controlled. That means participants are assigned by chance to Incb000928 or placebo, and neither the participants nor the study team knows who gets which treatment during the study.

Ongoing Clinical Trials on Incb000928

  • Study on the Effectiveness of INCB000928 for Patients with Fibrodysplasia Ossificans Progressiva

    Recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Portugal Spain

Glossary

  • Fibrodysplasia Ossificans Progressiva (FOP): A rare condition where bone forms in soft tissues such as muscles, tendons, or ligaments. This extra bone can limit movement over time.
  • Heterotopic ossification (HO): Bone growth in an unusual place, outside the normal skeleton. In this trial, researchers are looking for new HO lesions.
  • Lesion: An area of abnormal tissue or damage. In this study, it refers to new areas of unwanted bone formation.
  • Phase 2: A trial stage that usually checks whether a treatment may work and continues to study safety.
  • Randomized: Participants are placed into study groups by chance, not by choice. This helps make the results fairer.
  • Double-blind: Neither the participants nor the study team knows who is getting the study treatment or placebo during the trial. This helps reduce bias.
  • Placebo: A look-alike treatment with no active study drug. It is used for comparison.
  • Efficacy: How well a treatment works for the study goal.
  • Safety: How the treatment affects the body and whether unwanted medical problems happen.
  • Tolerability: How well people are able to take the treatment and handle it during the study.
  • Low-dose whole-body CT (WBCT): A special scan that uses a lower amount of radiation to take pictures of the whole body. In this trial, it is used to look for new bone lesions.
  • Baseline: The starting point before the study treatment is given.

References