Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. 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.
  2. 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.
  3. 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.
  4. 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

Exclusion Criteria:


  1. History of a clinically significant non-ALS neurologic disorder
  2. Inability to swallow capsules.
  3. Blood platelet count <150,000/mm^3.
  4. 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.
  5. 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.
  6. Women who are pregnant, planning to become pregnant, or are breastfeeding.
  7. Use of non-invasive ventilation (NIV) or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation.
  8. Current or anticipated need of a diaphragm pacing system (DPS).
  9. Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
  10. Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall (650) 249-9965Email iconEmail Study Center

Study Details


Contition
Amyotrophic Lateral Sclerosis
Age
18+
Phase
PHASE2
Participants Needed
279
Est. Completion Date
Nov 30, 2027
Treatment Type
INTERVENTIONAL

Sponsor
Corcept Therapeutics
ClinicalTrials.gov NCT Identifier
NCT05407324
Study Number
CORT113176-652

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