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Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

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

NCT07023835•Zydus Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of probable or definite Amyotrophic lateral sclerosis, according to the revised version of the El Escorial World Federation of Neurology criteria
•Time since onset of first symptom of Amyotrophic lateral sclerosis ≤24 months. Date of Amyotrophic lateral sclerosis symptom onset. For the purposes of this study, the date of symptom onset will be defined as the date the subject first had symptoms of their disease, i.e., limb weakness, dysarthria, dysphagia, shortness of breath, or fasciculations, from the screening visit.
•Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score of ≥35 at screening.
•Slow vital capacity: ≥60% of predicted capacity at the screening visit.
•Be able to swallow capsules.
•Either not currently receiving riluzole/sodium phenylbutyrate and taurursodiol/tofersen or on a stable dose of riluzole/sodium phenylbutyrate and taurursodiol/tofersen for at least 4 weeks before the screening visit. Subjects receiving riluzole/sodium phenylbutyrate and taurursodiol/tofersen are expected to remain on the same dose throughout the duration of the study.
•Either not currently receiving edaravone or on edaravone treatment. Subjects receiving edaravone must have completed at least 1 cycle of treatment before the screening visit and are expected to continue with a stable dose of edaravone treatment throughout the duration of the study.
•Capable of providing informed consent and complying with study procedures in the opinion of the investigator
•Completion in the randomized, double blind Usnoflast study (main study).
•Subjects who elect to continue treatment after completion of Usnoflast phase 2b study must enrol in the OLE within 28 days of the completion of Week 36 visit of the main study.
+1 more criteria

Exclusion Criteria

•Presence of unstable psychiatric disease, cognitive impairment, dementia, or substance abuse that would impair the ability of the subject to provide informed consent, in the opinion of the investigator.
•Serious illness (e.g., pneumonia, septicemia) within 4 weeks of the screening visit; infection requiring hospitalization or treatment with intravenous antibiotics, antivirals, or antifungals within 4 weeks of screening; chronic bacterial infection (such as tuberculosis) deemed unacceptable as per the judgment of the investigator.
•Active herpes zoster infection within 2 months prior to the screening visit.
•Any medical condition that promotes suicidal attempt or behavior within 6 months prior to the screening visit and in the opinion of the investigator might interfere with subject's participation in the study or is a risk for a suicide attempt.
•History of unstable or severe cardiac, pulmonary, oncological, hepatic, or renal disease or active cancer or another medically significant illness other than Amyotrophic lateral sclerosis, precluding safe participation of subject in this study in the opinion of the investigator.
•Known allergy, sensitivity, or intolerance to Investigational product or excipients.
•Subjects who have taken concomitant medications that are substrates of drug metaboliz-ing enzymes (Cytochrome P450 1A2 and/or Cytochrome P450 2B6) within 7 days or 5 half-lives of the medication (whichever is longer) before the first dose of Investigational product and throughout the study.
•Use of any steroids, colchicine, or anti-IL-1 inhibitors within 7 days or 5 half-lives of the medication (whichever is longer) prior to the first dose of Investigational product administration.
•Use of any investigational drug concurrently or within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of Investigational product administration.
•Any clinically significant condition and/or laboratory significant value that would prevent the subject from participating in the study in the opinion of the investigator.
+24 more criteria

Locations (17)

Zydus US015

La Jolla, California, United States

Zydus US008

Orange, California, United States

Zydus US013

San Francisco, California, United States

Zydus US005

New Britain, Connecticut, United States

Zydus US012

Tampa, Florida, United States

Zydus US007

Atlanta, Georgia, United States

Zydus US010

Boston, Massachusetts, United States

Zydus US006

Detroit, Michigan, United States

Zydus US014

Lincoln, Nebraska, United States

Zydus US003

Winston-Salem, North Carolina, United States

Key Dates

Start Date

September 17, 2025

Primary Completion Date

March 1, 2028

Completion Date

October 1, 2028

Last Updated

February 5, 2026

Enrollment

240

ESTIMATED participants

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

50 mg Usnoflast

DRUG

75 mg Usnoflast

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Usnoflast Neuromuscular Investigation for Treatment Efficacy in Amyotrophic Lateral Sclerosis

Inclusion Criteria

Exclusion Criteria

Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease.

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