Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-01-01 @ 1:13 PM
Study NCT ID:
NCT07023835
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Sponsor:
Zydus Therapeutics Inc.
Organization:
Study Overview
Official Title:
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Usnoflast Administered to Adult Subjects With ALS
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UNITE-ALS
Brief Summary:
Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis
Detailed Description:
A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter 36 weeks study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis followed by 16 weeks open label extension study.
This Open Label Extension will be a multicenter, 16-week, single arm study to confirm the long-term safety and efficacy of Usnoflast in subjects with ALS. Eligible subjects of all three arms of the main study will be recruited in the OLE phase and will receive Usnoflast (75 mg) for a total of 16 weeks BID (oral capsule administration).
This Open Label Extension will be a multicenter, 16-week, single arm study to confirm the long-term safety and efficacy of Usnoflast in subjects with ALS. Eligible subjects of all three arms of the main study will be recruited in the OLE phase and will receive Usnoflast (75 mg) for a total of 16 weeks BID (oral capsule administration).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: