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Monoclonal Antibodies
RO7204239 for Facioscapulohumeral Muscular Dystrophy (MANOEUVRE Trial)
Phase 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial will assess the safety and effectiveness of a drug to treat facioscapulohumeral muscular dystrophy (FSHD).
Who is the study for?
Adults who can walk on their own, have genetically confirmed FSHD1 or FSHD2 with specific clinical severity scores, and agree to keep their physical therapy routine stable during the study. Not for those pregnant, breastfeeding, hypersensitive to RO7204239 or its ingredients, with recent major illness/surgery affecting motor function, history of certain heart issues or malignancies.
What is being tested?
The trial is testing RO7204239—a monoclonal antibody targeting latent myostatin—against a placebo in adults with facioscapulohumeral muscular dystrophy (FSHD). It aims to assess the drug's effects on muscle function along with its safety and tolerability.
What are the potential side effects?
Potential side effects may include allergic reactions like anaphylaxis to RO7204239 or its components. Since it's an injection treatment, there might also be local skin reactions at the site of administration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RO7204239Experimental Treatment1 Intervention
Participants will complete a 4-week pre-treatment period to collect baseline movement data with a wearable device, then receive SC RO7204239 every 4 weeks for 52 weeks. After the treatment period, participants will have the option to receive RO7204239 for an additional 52 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will complete a 4-week pre-treatment period to collect baseline movement data with a wearable device, then receive subcutaneous (SC) placebo every 4 weeks for 52 weeks. After the treatment period, participants will have the option to receive RO7204239 for an additional 52 weeks.
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Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,103,116 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
902,245 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk by myself without help.I agree to keep my physical therapy and exercise routines the same during the study.I have been treated with anti-myostatin therapies.My condition is genetically confirmed as FSHD1 or FSHD2.My condition matches the symptoms of FSHD.I have a serious heart condition.I have not had a major illness in the last month.I haven't had any injuries or surgeries on my limbs that could affect my movement in the last 3 months.My heart scan shows significant issues, but I don't just have mitral valve prolapse.I haven't taken certain muscle-related drugs or steroids in the last 90 days.I have no cancer history, except for treated skin or cervical cancer.I don't have skin issues on my abdomen that would hide injection reactions.I have not had, nor am I planning to have, surgery that could affect my ability to move.
Research Study Groups:
This trial has the following groups:- Group 1: RO7204239
- Group 2: Placebo
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.