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ACTIVE NOT RECRUITINGPhase2

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

Sponsor: Corcept Therapeutics

NCT ID: NCT05407324

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Dazucorilant 300 mg (drug), Dazucorilant 150 mg (drug), Placebo (other), Dazucorilant (drug)
How long the study runs
Study runs about 60 months (dates as stated)
About the drug or intervention
Dazucorilant 300 mg — drug: 300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule. · Dazucorilant 150 mg — drug: 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 — other: Placebo will be administered once daily in capsules of placebo equivalent. · Dazucorilant — drug: Dazucorilant will be administered once daily in 75-mg capsules.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
279
Started
2022-11-15
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for amyotrophic lateral sclerosis
  • • Phase2 - 279 participants
  • • The purpose of this 2-part study is to assess the safety and efficacy of CORT113176 (dazucorilant) in patients with Amyotrophic Lateral Sclerosis (ALS)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with amyotrophic lateral sclerosis

Where?

  • • Stoke-on-Trent - 263

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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., complete 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 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.

Amyotrophic Lateral Sclerosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ tofersen

What the study is looking for

  • ✓Part 2 only: Use of ultra high-dose methylcobalamin for the treatment of ALS is permitted provided the patient has...

Who cannot take part

  • ✗History of a clinically significant non-ALS neurologic disorder
  • ✗Inability to swallow capsules.
  • ✗Blood blood clotting cell count \<150,000/mm\^3.
  • ✗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...
See the full 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 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.

Where Is This Study? (1 UK site)

263

Stoke-on-Trent ST4 6QG, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-09