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AOC 1020 for Facioscapulohumeral Muscular Dystrophy (FORTITUDE Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Avidity Biosciences, Inc.

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 through study completion; up to day 365

Awards & highlights

FORTITUDE Trial Summary

This trial tests a new drug for FSHD to see if it's safe, works well, and is effective. It's a double-blind study, meaning neither the patient nor doctor knows who's getting the drug.

Who is the study for?

Adults with confirmed FSHD1 or FSHD2 who can walk at least 10 meters and have at least one muscle region suitable for biopsy. They should not be pregnant, breastfeeding, or planning pregnancy soon, must follow contraceptive guidelines, and have a BMI under 35.0 kg/m^2. Those with recent biopsies, bleeding disorders, severe muscle wasting, or conditions that could affect study participation are excluded.Check my eligibility

What is being tested?

The trial is testing AOC 1020 against a placebo in adults with Facioscapulohumeral Muscular Dystrophy (FSHD). It's randomized and double-blind meaning neither the participants nor the researchers know who gets the real treatment versus placebo. The study will assess safety, tolerability of doses given intravenously and any potential benefits on muscle function.See study design

What are the potential side effects?

While specific side effects of AOC 1020 aren't listed as it's likely being tested for the first time in humans (Phase 1/2), common side effects may include reactions at injection site, fatigue, headache or flu-like symptoms; more serious risks might involve allergic reactions or impacts on liver/kidney functions.

FORTITUDE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events

Secondary outcome measures

Muscle drug concentration

Plasma pharmacokinetic (PK) parameters of AOC 1020

Urine drug concentration

FORTITUDE Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: AOC 1020 Regimen 3Experimental Treatment1 Intervention

Part B2 & C: AOC 1020 Dose Regimen 3; Five doses administered intravenously over 9 months

Group II: AOC 1020 Regimen 2Experimental Treatment1 Intervention

Part B1 & C: AOC 1020 Dose Regimen 2; Five doses administered intravenously over 9 months

Group III: AOC 1020 Regimen 1Experimental Treatment1 Intervention

Part A: AOC 1020 Dose Regimen 1; Five doses administered intravenously over 9 months

Group IV: Placebo (Saline)Placebo Group1 Intervention

Part A, B & C: Placebo; Five doses administered intravenously over 9 months

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Avidity Biosciences, Inc.Lead Sponsor

5 Previous Clinical Trials

613 Total Patients Enrolled

Media Library

AOC 1020 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05747924 — Phase 1 & 2

Muscular Dystrophy Research Study Groups: AOC 1020 Regimen 1, AOC 1020 Regimen 2, AOC 1020 Regimen 3, Placebo (Saline)

Muscular Dystrophy Clinical Trial 2023: AOC 1020 Highlights & Side Effects. Trial Name: NCT05747924 — Phase 1 & 2

AOC 1020 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05747924 — Phase 1 & 2

Frequently Asked Questions

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

Are people over the age of 35 eligible to participate in this investigation?

"This research trial is open to individuals aged 18 and over, yet younger than 65."

Answered by AI

Is there a particular demographic that is eligible to partake in the research?

"To be eligible for the trial, applicants should possess facio-scapulo-humeral dystrophy and fall within the 18 to 65 year old age bracket. 72 people are sought after in total."

Answered by AI

How many participants have enlisted in this research effort?

"Affirmative. According to information available on clinicaltrials.gov, the trial in question is actively recruiting participants. This research was first posted on March 1st 2023 and recently updated on March 23rd of the same year. 72 people are needed for this study at a single centre."

Answered by AI

Are there any vacancies for participants in this research trial?

"Affirmative. According to clinicaltrials.gov, the trial which was originally posted on March 1st 2023 has resumed recruitment activities; its last edit occurring on March 23rd 2023. The study seeks 72 participants from a single medical centre for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 1/2 Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD)

2023. "Phase 1/2 Study of AOC 1020 in Adults With Facioscapulohumeral Muscular Dystrophy (FSHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05747924.

All > Muscular Dystrophy