Clinical Trials in the Netherlands / NCT05407324
Active, not recruiting Phase 2

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

NCT05407324 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2022-11-15
Last updated
2026-09-24

Condition(s) studied

Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

Dazucorilant 300 mgDazucorilant 150 mgPlaceboDazucorilant

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

Dazucorilant 150 mg: Dazucorilant and placebo will be administered once daily in 4 capsules, 2 capsules with 75 mg dazucorilant/capsule, and 2 capsules of placebo equivalent.

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

Dazucorilant: Dazucorilant will be administered once daily in 75-mg capsules.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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. 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 (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.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
062 Phoenix Arizona
278 San Francisco California
287 Neptune City New Jersey
353 New York New York
108 Leuven Belgium
425 Hamilton Ontario
273 Montreal Quebec
422 Bron France
258 Lille France
257 Limoges France
261 Marseille France
423 Montpellier France
259 Nice France
262 Paris France
256 Tours France
255 Berlin Germany
270 Bonn Germany
268 Dresden Germany
260 Hanover Germany
265 Jena Germany
386 München Germany
267 Rostock Germany
269 Ulm Germany
253 Dublin Ireland
264 Utrecht Netherlands
283 Bydgoszcz Poland
385 Krakow Poland
254 Warsaw Poland
274 Warsaw Poland
302 Barcelona Spain
115 Barcelona Spain
303 Madrid Spain
282 Málaga Spain
194 Valencia Spain
263 Stoke-on-Trent United Kingdom

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05407324 on ClinicalTrials.gov ↗ ← All trials in the Netherlands