Status:
ACTIVE_NOT_RECRUITING
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
Corcept Therapeutics
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 participat...
Eligibility Criteria
Inclusion
- Male and female patients ≥18 years of age with Sporadic or familial ALS. In Part 1, patients must have a risk of ALS progression characterized by a European Network for the Cure of ALS (ENCALS) risk profile score ≥ -6 and ≤ -3. In Part 2 patients must have a risk of ALS progression characterized by an ENCALS risk profile score ≥ -7 and ≤ -3.
- If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening. Sodium phenylbutyrate and taurursodiol are not permitted for patients enrolled in Part 2 of the study.
- Part 2 only: Patients with a pathogenic mutation in superoxide dismutase 1 gene (SOD1) must not be receiving treatment with tofersen or eligible for treatment with tofersen if available. Patients who have received prior treatment with tofersen and discontinued due to safety and/or efficacy reasons prior to Screening are eligible.
- Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has been on a stable dose for ≥11 weeks prior to the Day 1 visit.
Exclusion
- History of a clinically significant non-ALS neurologic disorder
- Inability to swallow capsules.
- Blood platelet count \<150,000/mm\^3.
- Renal impairment indicated by Estimated Glomerular Filtration Rate (eGFR) ≤30 mL/min/1.73 m\^2. Part 2 only: Patients with a recent history of acute kidney injury should have returned to their baseline renal function prior to enrollment.
- Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus. Part 2 only: Known history of HIV or chronic/active infection with hepatitis C or hepatitis B virus; testing does not need to be performed if infection status is unknown.
- 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.
Key Trial Info
Start Date :
November 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT05407324
Start Date
November 15 2022
End Date
November 1 2027
Last Update
December 22 2025
Active Locations (35)
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1
062
Phoenix, Arizona, United States, 85013
2
278
San Francisco, California, United States, 94109
3
287
Neptune City, New Jersey, United States, 07753
4
353
New York, New York, United States, 10032