Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS).

Key facts

Study ID

NCT05407324

Run by

Corcept Therapeutics

People needed

279

Starts

2022-11-15

Expected to finish

2027-11-01

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Treatment Research Initiative to Cure ALS (TRICALS) 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.

You may not qualify if…

• 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 (i.e, eGFR prior to acute kidney injury) 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.
• Cancer that is currently being treated (except adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin, stage I endometrial cancer or carcinoma in situ of the cervix or breast) or a history of cancer with an expected survival < 2 years.
• Current or anticipated need of a diaphragm pacing system (DPS).
• Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.
• Taking, or have taken, any systemic, inhaled, or potent dermatologic topical corticosteroids (Class I to III) within a period equivalent to 5 half-lives of the corticosteroid used prior to first dose of study drug. Patients who have stopped glucocorticoid use should have an alternative option if their condition deteriorates during the study.

Where it is running

• 264 — Utrecht, Netherlands (enrolling)
• 270 — Bonn, Germany (enrolling)
• 278 — San Francisco, California, United States (enrolling)
• 287 — Neptune City, New Jersey, United States (enrolling)
• 353 — New York, New York, United States (enrolling)
• 062 — Phoenix, Arizona, United States (enrolling)
• 257 — Limoges, France
• 261 — Marseille, France
• 423 — Montpellier, France
• 259 — Nice, France
• 262 — Paris, France
• 256 — Tours, France
• 255 — Berlin, Germany
• 268 — Dresden, Germany
• 260 — Hanover, Germany
• 265 — Jena, Germany
• 386 — München, Germany
• 267 — Rostock, Germany
• 269 — Ulm, Germany
• 253 — Dublin, Ireland
• 283 — Bydgoszcz, Poland
• 385 — Krakow, Poland
• 254 — Warsaw, Poland
• 274 — Warsaw, Poland
• 302 — Barcelona, Spain

Full record on ClinicalTrials.gov

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