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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; up to day 365

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Muscle drug concentration (Cohorts A, B & C)
Plasma pharmacokinetic (PK) parameters of AOC 1020 (Cohorts A & B)

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: AOC 1020 Regimen 3Experimental Treatment1 Intervention
Cohort C: AOC 1020 Dose Regimen 3; Eight doses administered intravenously over approximately 10 months
Group II: AOC 1020 Regimen 2Experimental Treatment1 Intervention
Cohort B1: AOC 1020 Dose Regimen 2; Five doses administered intravenously over 9 months
Group III: AOC 1020 Regimen 1Experimental Treatment1 Intervention
Cohort A: AOC 1020 Dose Regimen 1; Five doses administered intravenously over 9 months
Group IV: Placebo (Saline) Regimen 1Placebo Group1 Intervention
Cohort A \& B: Placebo; Five doses administered intravenously over 9 months
Group V: Placebo (Saline) Regimen 2Placebo Group1 Intervention
Cohort C: Placebo; Eight doses administered intravenously over approximately 10 months

Find a Location

Who is running the clinical trial?

Avidity Biosciences, Inc.Lead Sponsor
7 Previous Clinical Trials
846 Total Patients Enrolled

Media Library

AOC 1020 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05747924 — Phase 1 & 2
Follicle Stimulating Hormone Research Study Groups: Placebo (Saline) Regimen 1, Placebo (Saline) Regimen 2, AOC 1020 Regimen 1, AOC 1020 Regimen 2, AOC 1020 Regimen 3
Follicle Stimulating Hormone 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
~54 spots leftby Oct 2026
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