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NCT05085964 · ClinicalTrials.gov registry record · Phase 2
An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa
A Phase 2 study, sponsored by Laboratoires Thea.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT05085964 is a Phase 2 study that was terminated before completion, run by Laboratoires Thea. The registered enrollment target is 21 participants.
The verdict
NCT05085964, a Phase 2 study, was terminated before completion, sponsored by Laboratoires Thea.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
PQ-421a-002 (Helia) is an open-label, extension study to evaluate the safety, tolerability and efficacy of QR 421a (ultevursen) administered via intravitreal (IVT) injection in one or both eyes, in subjects ≥ 12 years of age with RP due to mutations in exon 13 of the USH2A gene, for an anticipated period of 24 months, or until provision of continued treatment by other means is available, provided the subject's benefit-risk determination remains positive.
Interventions
- DRUG RNA antisense oligonucleotide for intravitreal injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2022-10-18 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05085964
The ClinicalTrials.gov registry entry for NCT05085964 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Laboratoires Thea, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RNA antisense oligonucleotide for intravitreal injection is the first listed.
NCT05085964 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05085964 about?
NCT05085964 is a clinical study titled "An Open-Label Extension Study to Evaluate Safety & Tolerability of QR-421a in Subjects With Retinitis Pigmentosa". PQ-421a-002 (Helia) is an open-label, extension study to evaluate the safety, tolerability and efficacy of QR 421a (ultevursen) administered via intravitreal (IVT) injection in one or both eyes, in subjects ≥ 12 years of age with RP due to mutations in exon 13 of the USH2A gene, for an anticipated p...
What is the current status of trial NCT05085964?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2021-09-16. Estimated completion is 2022-10-18.
What interventions are being tested in trial NCT05085964?
The interventions under investigation include: RNA antisense oligonucleotide for intravitreal injection (DRUG).
Who is sponsoring clinical trial NCT05085964?
This trial is sponsored by Laboratoires Thea, which has 11 total clinical trials registered on ClinicalTrials.gov.
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