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Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
NCT05407324 · Corcept Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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)
About this study
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 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 who complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.
In Part 2, eligible ALS patients will receive open-label treatment to evaluate dose titration and tolerability of dazucorilant. The dose titration will begin with an initial 75 mg once daily dose, and the dose will be titrated up as tolerated in 75 mg increments until the 300 mg once daily target dose is reached and maintained for 3 weeks. Patients who complete participation in the dose-titration treatment period will be eligible to continue treatment with dazucorilant 300 mg once daily in a 52-week open-label extension portion of the study.
Eligibility criteria
Inclusion Criteria:
* 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 Criteria:
* 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.
Study design
Enrollment target: 279 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2022-11-15
Estimated completion: 2027-11
Last updated: 2026-03-30
Interventions
Drug: Dazucorilant 300 mgDrug: Dazucorilant 150 mgOther: PlaceboDrug: Dazucorilant
Primary outcomes
- • 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)
- • Incidence of treatment-emergent AEs and SAEs (Baseline up to Week 12)
Sponsor
Corcept Therapeutics · industry
Contacts & investigators
ContactClinical Trial Lead · contact · study652@corcept.com · (650) 249-9965
ContactCorcept Therapeutics Incorporated · contact
InvestigatorSophia Majeed, PharmD, PhD · study_director, Corcept Therapeutics Incorporated
All locations (35)
062Recruiting
Phoenix, Arizona, United States
278Recruiting
San Francisco, California, United States
287Recruiting
Neptune City, New Jersey, United States
353Recruiting
New York, New York, United States
108Active Not Recruiting
Leuven, Belgium
425Active Not Recruiting
Hamilton, Ontario, Canada
273Active Not Recruiting
Montreal, Quebec, Canada
422Active Not Recruiting
Bron, France
258Active Not Recruiting
Lille, France
257Active Not Recruiting
Limoges, France
261Active Not Recruiting
Marseille, France
423Active Not Recruiting
Montpellier, France
259Active Not Recruiting
Nice, France
262Active Not Recruiting
Paris, France
256Active Not Recruiting
Tours, France
255Active Not Recruiting
Berlin, Germany
270Active Not Recruiting
Bonn, Germany
268Active Not Recruiting
Dresden, Germany
260Active Not Recruiting
Hanover, Germany
265Active Not Recruiting
Jena, Germany
386Active Not Recruiting
München, Germany
267Active Not Recruiting
Rostock, Germany
269Active Not Recruiting
Ulm, Germany
253Active Not Recruiting
Dublin, Ireland
264Active Not Recruiting
Utrecht, Netherlands
283Active Not Recruiting
Bydgoszcz, Poland
385Active Not Recruiting
Krakow, Poland
254Active Not Recruiting
Warsaw, Poland
274Active Not Recruiting
Warsaw, Poland
302Active Not Recruiting
Barcelona, Spain
115Active Not Recruiting
Barcelona, Spain
303Active Not Recruiting
Madrid, Spain
282Active Not Recruiting
Málaga, Spain
194Active Not Recruiting
Valencia, Spain
263Active Not Recruiting
Stoke-on-Trent, United Kingdom