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INCB000928 for Stone Man Syndrome (Progress Trial)
Phase 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female and male adults and adolescents ≥ 12 years of age with a diagnosis of FOP
Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation
Must not have
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
HIV, HBV, or HCV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 24
Summary
This trial is testing a new drug called INCB000928 to help people with a rare condition called fibrodysplasia ossificans progressiva (FOP). FOP causes soft tissues to turn into bone, and there are few treatments available. The study will check if the drug is safe and effective in stopping or slowing this abnormal bone growth.
Who is the study for?
This trial is for adults and adolescents aged 12 or older with fibrodysplasia ossificans progressiva (FOP), also known as Stone Man Syndrome. Participants must be able to undergo specific imaging procedures without intubation and agree to prevent pregnancy or fathering children. Those with severe FOP, certain infections like HIV/HBV/HCV, a high CAJIS score, or other medical conditions that could affect the study can't join.
What is being tested?
The trial is testing INCB000928's effectiveness, safety, and how well it's tolerated in people with FOP compared to a placebo. It's a Phase 2 study where participants are randomly assigned to either receive INCB000928 or a placebo without knowing which one they're getting (double-blind).
What are the potential side effects?
While specific side effects of INCB000928 aren't listed here, common ones in trials may include reactions at the injection site, fatigue, headache, nausea. Since this medication targets FOP symptoms directly related to muscle tissue ossification; there might be unique risks involved.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 or older and have been diagnosed with FOP.
Select...
I can have a full-body CT scan without needing a breathing tube.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on treatment for a long-term or active infection.
Select...
I am infected with HIV, HBV, or HCV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 12 and week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and week 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Double Blind Period: Total volume of new heterotopic ossification (HO)
Secondary study objectives
Double-blind Period: Proportion of participants with a clinically meaningful improvement in the flare-related symptoms
Double-blind Period: Total number of new flares
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group A: INCB000928Experimental Treatment2 Interventions
Participants will receive INCB000928 for 24 weeks (double-blind period). Participants who complete the double-blind period will continue into open-label extension period for an additional 52 weeks.
Group II: Group B: Placebo followed by INCB000928Placebo Group1 Intervention
Participants will receive placebo for 24 weeks (double-blind period). Participants who completed the double-blind period will receive INCB000928 in the 52 week open-label extension period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
INCB000928
2021
Completed Phase 2
~70
placebo
2010
Completed Phase 4
~6580
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Stone Man Syndrome, or Fibrodysplasia Ossificans Progressiva (FOP), involves abnormal bone formation in muscles and connective tissues. Treatments like INCB000928 likely target the ACVR1 gene mutation and inhibit the BMP signaling pathway to prevent this abnormal bone growth.
These mechanisms are vital for FOP patients as they help to slow disease progression, maintain mobility, and enhance quality of life.
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Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
387 Previous Clinical Trials
63,552 Total Patients Enrolled
Kurt Brown, MDStudy DirectorIncyte Corporation
3 Previous Clinical Trials
318 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 12 or older and have been diagnosed with FOP.You are willing to prevent pregnancy or becoming a parent based on the conditions described below.I can have a full-body CT scan without needing a breathing tube.I am currently on treatment for a long-term or active infection.I am infected with HIV, HBV, or HCV.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: INCB000928
- Group 2: Group B: Placebo followed by INCB000928
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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