Dazucorilant in Patients With Amyotrophic Lateral Sclerosis (DAZALS)

• ClinicalTrials.gov Identifier: NCT05407324
• Recruitment Status: Recruiting
• First Posted: June 7, 2022
• Last Update Posted: March 10, 2023
• Sponsor: Corcept Therapeutics
• Information provided by (Responsible Party): Corcept Therapeutics

Tracking Information

• First Submitted Date: June 2, 2022
• First Posted Date: June 7, 2022
• Last Update Posted Date: March 10, 2023
• Actual Study Start Date: November 15, 2022
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 2, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 2, 2022)

• Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer). [ Time Frame: Baseline to Week 24 ]
• Change from Baseline to Week 24 in Percent Slow Vital Capacity [ Time Frame: Baseline to Week 24 ]
• Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [ Time Frame: Baseline to Week 24 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
• Official Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
• 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 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Amyotrophic Lateral Sclerosis

Intervention

• Drug: Dazucorilant 300 mg
  300 mg of dazucorilant will be administered once daily in 4 softgel capsules of 75 mg dazucorilant/capsule.
• Drug: 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.
• Other: Placebo
  Placebo will be administered once daily in 4 softgel capsules of placebo equivalent.

Study Arms

• Experimental: CORT113176 (Dazucorilant) 300 mg
  300 mg of dazucorilant will be administered once daily.
  Intervention: Drug: Dazucorilant 300 mg
• Experimental: CORT113176 (Dazucorilant) 150 mg
  150 mg of dazucorilant will be administered once daily.
  Intervention: Drug: Dazucorilant 150 mg
• Placebo Comparator: Placebo (matched to study drug)
  Placebo will be administered once daily.
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 2, 2022): 198
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 2024
• Estimated Primary Completion Date: May 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trial Lead; (650) 327-3270; study652@corcept.com

• Listed Location Countries: Belgium, France, Netherlands, Poland

Administrative Information

• NCT Number: NCT05407324
• Other Study ID Numbers: CORT113176-652; 2021-005611-31 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Corcept Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Corcept Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Grace Mann, PhD; Corcept Therapeutics

• PRS Account: Corcept Therapeutics
• Verification Date: March 2023