Clinical trial

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

Name

CORT113176-652

Description

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

Trial arms

Trial start

2022-11-15

Estimated PCD

2024-10-01

Trial end

2027-05-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Dazucorilant 300 mg

300 mg of dazucorilant will be administered once daily in 4 softgel capsules of 75 mg dazucorilant/capsule.

Arms:

CORT113176 (Dazucorilant) 300 mg

Dazucorilant 150 mg

Dazucorilant and placebo will be administered once daily in 4 softgel capsules, 2 capsules with 75 mg dazucorilant/capsule and 2 capsules of placebo equivalent.

Arms:

CORT113176 (Dazucorilant) 150 mg

Placebo

Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.

Arms:

Placebo (matched to study drug)

Size

249

Primary endpoint

Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.

Baseline to Week 24

Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs.

Baseline to Week 24

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 249, 'type': 'ACTUAL'}}

Updated at

2024-04-26

1 organization

1 product

1 indication

Product

Dazucorilant

Indication

Amyotrophic lateral sclerosis

Organization

Corcept Therapeutics