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Clinical Trials in Ireland / NCT05407324
Recruiting Phase 2

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

NCT05407324 · tracked via the Priya Life Science Ireland tracker
Sponsor
Corcept Therapeutics
Phase
Phase 2
Started
2022-11-15
Last updated
2026-06-16

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 Recruiting
278 San Francisco California Recruiting
287 Neptune City New Jersey Recruiting
353 New York New York Recruiting
108 Leuven Belgium Active Not Recruiting
425 Hamilton Ontario Active Not Recruiting
273 Montreal Quebec Active Not Recruiting
422 Bron France Active Not Recruiting
258 Lille France Active Not Recruiting
257 Limoges France Active Not Recruiting
261 Marseille France Active Not Recruiting
423 Montpellier France Active Not Recruiting
259 Nice France Active Not Recruiting
262 Paris France Active Not Recruiting
256 Tours France Active Not Recruiting
255 Berlin Germany Active Not Recruiting
270 Bonn Germany Recruiting
268 Dresden Germany Active Not Recruiting
260 Hanover Germany Active Not Recruiting
265 Jena Germany Active Not Recruiting
386 München Germany Active Not Recruiting
267 Rostock Germany Active Not Recruiting
269 Ulm Germany Active Not Recruiting
253 Dublin Ireland Active Not Recruiting
264 Utrecht Netherlands Recruiting
283 Bydgoszcz Poland Active Not Recruiting
385 Krakow Poland Active Not Recruiting
254 Warsaw Poland Active Not Recruiting
274 Warsaw Poland Active Not Recruiting
302 Barcelona Spain Active Not Recruiting
115 Barcelona Spain Active Not Recruiting
303 Madrid Spain Active Not Recruiting
282 Málaga Spain Active Not Recruiting
194 Valencia Spain Active Not Recruiting
263 Stoke-on-Trent United Kingdom Active Not Recruiting
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 Ireland