Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Phase 2

Active, not recruiting

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: Dazucorilant 150 mg; Drug: Dazucorilant 300 mg; Other: Placebo

• Registration Number: NCT05407324
• Lead Sponsor: Corcept Therapeutics

Brief Summary

The purpose of this study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Detailed Description

Eligible ALS patients will be randomized to one of three treatment arms (1:1:1) across North America and Europe for a 24-week double-blind treatment period.

Patients who complete participation (i.e., completed all visits) in the double-blind treatment period will be eligible for participation in a 132-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 132-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.

Study Timeline

• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-02
• Study First Posted: 2022-06-07
• Study Start: 2022-11-15
• Primary Completion: 2024-10-22
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-18
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 249

Inclusion Criteria

• Male and female patients ≥18 years of age with Sporadic or familial ALS
• If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening.

Exclusion Criteria

• History of a clinically significant non-ALS neurologic disorder
• Inability to swallow capsules.
• Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus
• Women who are pregnant, planning to become pregnant, or are breastfeeding.
• Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
• Current or anticipated need of a diaphragm pacing system (DPS).
• Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
• Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CORT113176 (Dazucorilant) 150 mg	Dazucorilant 150 mg	150 mg of dazucorilant will be administered once daily.
CORT113176 (Dazucorilant) 300 mg	Dazucorilant 300 mg	300 mg of dazucorilant will be administered once daily.
Placebo (matched to study drug)	Placebo	Placebo will be administered once daily.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs.	Baseline to Week 24
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.	Baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 24 in Percent Slow Vital Capacity	Baseline to Week 24
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)	Baseline to Week 24
Time to Death	From randomization date to the date of death from any cause up to 156 weeks
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).	Baseline to Week 24

Trial Locations

Locations (35)

062; 🇺🇸 Phoenix, Arizona, United States

278; 🇺🇸 San Francisco, California, United States

287; 🇺🇸 Neptune, New Jersey, United States

353; 🇺🇸 New York, New York, United States

108; 🇧🇪 Leuven, Belgium

425; 🇨🇦 Hamilton, Ontario, Canada

273; 🇨🇦 Montréal, Quebec, Canada

422; 🇫🇷 Bron, France

258; 🇫🇷 Lille, France

257; 🇫🇷 Limoges, France

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