NCT05407324

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 279 (estimated)
• Sponsor: Corcept Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Detailed description

In Part 1, 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 who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period. In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dazucorilant 300 mg	300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule.
DRUG	Dazucorilant 150 mg	Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent.
OTHER	Placebo	Placebo will be administered once daily in capsules of placebo equivalent.
DRUG	Dazucorilant	Dazucorilant will be administered once daily in 75-mg capsules.

Timeline

• Start date: 2022-11-15
• Primary completion: 2026-09-01
• Completion: 2027-11-01
• First posted: 2022-06-07
• Last updated: 2026-03-30

Locations

35 sites across 10 countries: United States, Belgium, Canada, France, Germany, Ireland, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study