Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

Corcept Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: Dazucorilant 300 mg; Other: Placebo; Drug: Dazucorilant 150 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05407324

2021-005611-31 (EudraCT Number)

CORT113176-652

Details and patient eligibility

About

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

Full 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.

Enrollment: 249 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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249 participants in 3 patient groups, including a placebo group

CORT113176 (Dazucorilant) 300 mg

Experimental group

Description:

300 mg of dazucorilant will be administered once daily.

Treatment:

Drug: Dazucorilant 300 mg

CORT113176 (Dazucorilant) 150 mg

Experimental group

Description:

150 mg of dazucorilant will be administered once daily.

Treatment:

Drug: Dazucorilant 150 mg

Placebo (matched to study drug)

Placebo Comparator group

Description:

Placebo will be administered once daily.

Treatment:

Other: Placebo