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NCT05132569 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6
- Enrollment target
NCT05132569 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 6 participants.
The verdict
NCT05132569, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6 participants
- Enrollment target
Study Summary
This was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe generalized myasthenia gravis (gMG), who received Standard of Care (SoC). The double-blind (DB) treatment period of 26 weeks comprised of 7 site visits followed by a 2-year open label extension (OLE) period with quarterly visits. The efficacy of tolebrutinib versus placebo during the DB period was assessed by clinical evaluations, including scales based on physician examination or direct participant feedback i.e., patient reported outcomes (PROs). These evaluations continued during the OLE to measure long term efficacy and safety.
Interventions
- DRUG Placebo
- DRUG Tolebrutininb
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2023-02-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05132569
The ClinicalTrials.gov registry entry for NCT05132569 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05132569 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05132569 about?
NCT05132569 is a clinical study titled "Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia Gravis". This was a multicenter, randomized, double-blind, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of tolebrutinib compared with placebo in adult participants aged 18 to 85 years old with moderate-to-severe generalized myasthenia gravis (gMG), who received Standard of Care (SoC)...
What is the current status of trial NCT05132569?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6 participants. The study started on 2021-12-03. Estimated completion is 2023-02-21.
What interventions are being tested in trial NCT05132569?
The interventions under investigation include: Placebo (DRUG), Tolebrutininb (DRUG).
Who is sponsoring clinical trial NCT05132569?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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