Dazucorilant in Patients With Amyotrophic Lateral Sclerosis

NCT05407324
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Recruiting
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Participants
279
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Lead sponsor
Corcept Therapeutics
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Start date
2022-11-15
clinicaltrials.gov
Number of sites
35
clinicaltrials.gov

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).
clinicaltrials.gov
Acronym
DAZALS
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Short title
Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
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Official title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2027-11-01
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First posted
2022-06-07
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Registry last updated
2026-06-16
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Primary completion date
2026-10-01
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Start date
2022-11-15
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Participants
279
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Participant count basis
Estimated
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Planned participants
279
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Protocol amendments
7
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Randomisation ratio
1:1:1
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Number of sites
35
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Corcept Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05407324
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ClinicalTrials.gov ID
NCT05407324
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Care providers, Investigators
Sources for study design
clinicaltrials.gov

  1. Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.

    Timeframe: Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  2. Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs

    Timeframe: Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  3. Incidence of treatment-emergent AEs and SAEs

    Timeframe: Baseline up to Week 12

    This outcome measure is assessed in study Part 2.

  4. Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug

    Timeframe: Baseline up to Week 12

    This outcome measure is assessed in study Part 2.

  1. Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)

    Timeframe: Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  2. Change from Baseline to Week 24 in Percent Slow Vital Capacity

    Timeframe: Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  3. Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

    Timeframe: Baseline to Week 24

    This outcome measure is assessed in study Part 1.

  4. Time to Death

    Timeframe: From randomization date to the date of death from any cause up to 156 weeks

    This outcome measure is assessed in study Part 1.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • 062Phoenix, United StatesRecruiting
  • 278San Francisco, United StatesRecruiting
  • 287Neptune City, United StatesRecruiting
  • 353New York, United StatesRecruiting
  • 108Leuven, BelgiumActive, not recruiting
  • 425Hamilton, CanadaActive, not recruiting
  • 273Montreal, CanadaActive, not recruiting
  • 422Bron, FranceActive, not recruiting
  • 258Lille, FranceActive, not recruiting
  • 257Limoges, FranceActive, not recruiting
  • 261Marseille, FranceActive, not recruiting
  • 423Montpellier, FranceActive, not recruiting
  • 259Nice, FranceActive, not recruiting
  • 262Paris, FranceActive, not recruiting
  • 256Tours, FranceActive, not recruiting
  • 255Berlin, GermanyActive, not recruiting
  • 270Bonn, GermanyRecruiting
  • 268Dresden, GermanyActive, not recruiting
  • 260Hanover, GermanyActive, not recruiting
  • 265Jena, GermanyActive, not recruiting
  • 386München, GermanyActive, not recruiting
  • 267Rostock, GermanyActive, not recruiting
  • 269Ulm, GermanyActive, not recruiting
  • 253Dublin, IrelandActive, not recruiting
  • 264Utrecht, NetherlandsRecruiting

And 10 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2021-005611-31
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)