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A Phase 3 Study to Evaluate AOC 1020 in Participants with FSHD
EU CTIS ID: 2025-521012-18-00
What this study is testing
To evaluate the efficacy of AOC 1020 on functional mobility
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be willing and able to comply with all study requirements. When enrolling participants who are minors, it is necessary to also obtain consent from a legally designated representative and the participant will receive information in a way adapted to their age and mental maturity.
- 2. Male and females with FSHD confirmed by documented genetic diagnosis as defined below: - FSHD1 - FSHD2
- 3. 18 to 70 years of age at time of informed consent
- 4. Able to walk independently at pre-specified walking speed (orthoses or ankle braces are allowed) for at least 10 meters at screening.
You likely can't join if
- 1. Females who are pregnant, breastfeeding, or planning to become pregnant during the study period or
- 10. Treatment with an oligonucleotide within 9 months of Screening
- 11. Blood or plasma donation within 16 weeks of Study Day 1
- 12. Recent history of or current drug or alcohol abuse in the opinion of the Investigator
- 13. History of multiple drug allergies or history of allergic reaction to any component of, or excipient in, the Study Drug
- 14. Presence or history of clinically significant illness, medical condition, or abnormal test result/finding that, in the opinion of the Investigator, could affect a participant’s safety or their ability to comply with study procedures and/or complete the study visit schedule. This may include, but is not limited to, a history of cardiovascular or central nervous system disease, neuromuscular diseases other than FSHD (e.g., myopathy, neuropathy, neuromuscular junction disorders), a cardiopulmonary condition, or a clinically significant mental disorder
See the full eligibility criteria
Who can join
- 1. Must have given written informed consent (signed and dated) and any authorizations required by local law and be willing and able to comply with all study requirements. When enrolling participants who are minors, it is necessary to also obtain consent from a legally designated representative and the participant will receive information in a way adapted to their age and mental maturity.
- 2. Male and females with FSHD confirmed by documented genetic diagnosis as defined below: - FSHD1 - FSHD2
- 3. 18 to 70 years of age at time of informed consent
- 4. Able to walk independently at pre-specified walking speed (orthoses or ankle braces are allowed) for at least 10 meters at screening.
What rules you out
- 1. Females who are pregnant, breastfeeding, or planning to become pregnant during the study period or
- 10. Treatment with an oligonucleotide within 9 months of Screening
- 11. Blood or plasma donation within 16 weeks of Study Day 1
- 12. Recent history of or current drug or alcohol abuse in the opinion of the Investigator
- 13. History of multiple drug allergies or history of allergic reaction to any component of, or excipient in, the Study Drug
- 14. Presence or history of clinically significant illness, medical condition, or abnormal test result/finding that, in the opinion of the Investigator, could affect a participant’s safety or their ability to comply with study procedures and/or complete the study visit schedule. This may include, but is not limited to, a history of cardiovascular or central nervous system disease, neuromuscular diseases other than FSHD (e.g., myopathy, neuropathy, neuromuscular junction disorders), a cardiopulmonary condition, or a clinically significant mental disorder
- 2. Males or females not willing to comply with the contraceptive requirements
- 3. Screening laboratory results or any other clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion.
- 4. BP > 140/90 mmHg at Screening
- 5. Anticipated survival less than 2 years
- 6. Evidence of current or chronic infection with hepatitis C, hepatitis B, or HIV (including chronic infection requiring ongoing treatment to maintain viral suppression)
- 7. Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1 or ongoing symptoms related to recent infection causing impairment to ADL in the opinion of the Investigator
- 8. Malignancy within 5 years, except for basal or squamous cell carcinoma, melanoma in situ of the skin, carcinoma in situ of the cervix, or other malignancies within 5 years that have been treated with curative intent and which are not expected to recur
- 9. Treatment with another investigational drug or biological agent within 1 month of Screening or 5 half-lives of the drug, whichever is longer; or participation or plan to participate in another interventional study with an investigational drug or device or other types of interventional studies (including those studying behavioral modification and/or physical therapy) while on study
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.