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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 12 and week 24
Awards & highlights

Progress Trial Summary

This trial is testing a new drug to treat fibrodysplasia ossificans progressiva, a rare disorder that causes the body's muscles and connective tissue to turn into bone.

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.Check my eligibility
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).See study design
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.

Progress Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
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.

Progress Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Double Blind Period: Total volume of new heterotopic ossification (HO)
Secondary outcome measures
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)

Progress 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
placebo
2010
Completed Phase 4
~6580
INCB000928
2021
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
362 Previous Clinical Trials
55,023 Total Patients Enrolled
Kurt Brown, MDStudy DirectorIncyte Corporation
3 Previous Clinical Trials
318 Total Patients Enrolled

Media Library

INCB000928 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05090891 — Phase 2
Stone Man Syndrome Research Study Groups: Group A: INCB000928, Group B: Placebo followed by INCB000928
Stone Man Syndrome Clinical Trial 2023: INCB000928 Highlights & Side Effects. Trial Name: NCT05090891 — Phase 2
INCB000928 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05090891 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being asked to participate in this clinical trial?

"The sponsor, Incyte Corporation, needs to enroll 60 eligible patients from different hospitals including Investigative Site US002 in Philadelphia, Pennsylvania and Investigative Site US004 in Rochester, Minnesota."

Answered by AI

Who would be a good candidate to join this experiment?

"Myositis ossificans patients aged 12 to 99 are encouraged to apply for this trial, of which there are 60 slots available."

Answered by AI

Are pediatric patients allowed in this particular research program?

"Eligibility criteria for this study includes being between 12 to 99 years old."

Answered by AI

Are there still opportunities for people to participate in this research?

"If you're interested, this trial might be for you. The information was first posted on May 5th, 2022 and the most recent update was October 17th, 2022."

Answered by AI

Can you please provide more details on the potential side effects of INCB000928?

"INCB000928's safety scores a 2 because, while there is evidence that it is safe, there is no data supporting its efficacy."

Answered by AI
~21 spots leftby Apr 2025