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

Study Purpose:

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

Study Status:

Recruiting

Disease:

Amyotrophic Lateral Sclerosis

Study Type:

Interventional

Type of Intervention:

Drug, N/A

Intervention Name:

Dazucorilant 300 mg, Dazucorilant 150 mg, Placebo

Placebo:

Yes

Phase:

Phase 2

Study Chair(s)/Principal Investigator(s):

Grace Mann, PhD, Corcept Therapeutics

Clinicaltrials.gov ID:

NCT05407324

Neals Affiliated?

No

Coordinating Center Contact Information

Clinical Trial Lead / email hidden; JavaScript is required / (650) 327-3270

Full Study Summary:

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

Patients who complete participation (i.e., complete all visits) in the double-blind treatment period will be eligible for participation in a 24-week open-label extension (OLE) study. A daily dose of 300 mg dazucorilant will be used in the 24-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 24-week follow-up period.

Study Sponsor:

Corcept Therapeutics

Estimated Enrollment:

198

Estimated Study Start Date:

11 / 15 / 2022

Estimated Study Completion Date:

11 / 01 / 2024

Posting Last Modified Date:

04 / 12 / 2023

Date Study Added to neals.org:

06 / 07 / 2022

Minimum Age:

18 Years

Maximum Age:

N/A

Inclusion Criteria:

- Male and female patients ≥18 years of age with Sporadic or familial ALS

- If taking riluzole and/or edaravone, 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.

108 | Recruiting

Leuven 3000
Belgium

258 | Recruiting

Lille 59037
France

257 | Recruiting

Limoges 87042
France

261 | Recruiting

Marseille 13385
France

259 | Recruiting

Nice 06001
France

262 | Recruiting

Paris 75651
France

256 | Recruiting

Tours 37000
France

264 | Recruiting

Utrecht 3584 CW
Netherlands

283 | Recruiting

Bydgoszcz 85-163
Poland

254 | Recruiting

Warszawa 01-684
Poland

274 | Recruiting

Warszawa 02-473
Poland