Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
DAZALS
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety and Efficacy of CORT113176 (Dazucorilant) in Patients With Amyotrophic Lateral Sclerosis (DAZALS)
2 other identifiers
interventional
279
10 countries
35
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2022
Longer than P75 for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
March 30, 2026
March 1, 2026
3.8 years
June 2, 2022
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
This outcome measure is assessed in study Part 1.
Baseline to Week 24
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), treatment-related AEs, AEs by severity, and deaths due to AEs
This outcome measure is assessed in study Part 1.
Baseline to Week 24
Incidence of treatment-emergent AEs and SAEs
This outcome measure is assessed in study Part 2.
Baseline up to Week 12
Incidence of treatment-emergent AEs leading to dose interruptions, dose reductions, and/or discontinuations of study drug
This outcome measure is assessed in study Part 2.
Baseline up to Week 12
Secondary Outcomes (4)
Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer)
Baseline to Week 24
Change from Baseline to Week 24 in Percent Slow Vital Capacity
Baseline to Week 24
Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Baseline to Week 24
Time to Death
From randomization date to the date of death from any cause up to 156 weeks
Study Arms (4)
Part 1: CORT113176 (Dazucorilant) 300 mg
EXPERIMENTAL300 mg of dazucorilant will be administered once daily.
Part 1: CORT113176 (Dazucorilant) 150 mg
EXPERIMENTAL150 mg of dazucorilant will be administered once daily.
Part 1: Placebo (matched to study drug)
PLACEBO COMPARATORPlacebo will be administered once daily.
Part 2: CORT113176 (Dazucorilant) 75 - 300 mg Dose-titration
EXPERIMENTAL75 mg of dazucorilant will be administered once daily for 1 week, and increased weekly in 75 mg increments up to 300 mg once daily.
Interventions
300 mg of dazucorilant will be administered once daily in 4 capsules of 75 mg dazucorilant/capsule.
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 will be administered once daily in capsules of placebo equivalent.
Dazucorilant will be administered once daily in 75-mg capsules.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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 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.
- Current or anticipated need of a diaphragm pacing system (DPS).
- Currently using glucocorticoids or have a history of regular systemic glucocorticoid use within the last 12 months.
- Previous exposure or treatment with glucocorticoid receptor modulators or antagonists.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
062
Phoenix, Arizona, 85013, United States
278
San Francisco, California, 94109, United States
287
Neptune City, New Jersey, 07753, United States
353
New York, New York, 10032, United States
108
Leuven, 3000, Belgium
425
Hamilton, Ontario, L8N 3Z5, Canada
273
Montreal, Quebec, H3A2B4, Canada
422
Bron, 69500, France
258
Lille, 59037, France
257
Limoges, 87042, France
261
Marseille, 13385, France
423
Montpellier, 42395, France
259
Nice, 06001, France
262
Paris, 75651, France
256
Tours, 37000, France
255
Berlin, 13353, Germany
270
Bonn, 53127, Germany
268
Dresden, 1307, Germany
260
Hanover, 30625, Germany
265
Jena, 7747, Germany
386
München, 81675, Germany
267
Rostock, 18147, Germany
269
Ulm, 89081, Germany
253
Dublin, D09 YD60, Ireland
264
Utrecht, 3584 CW, Netherlands
283
Bydgoszcz, 85-163, Poland
385
Krakow, 30721, Poland
254
Warsaw, 01-684, Poland
274
Warsaw, 02-473, Poland
302
Barcelona, 08003, Spain
115
Barcelona, 08035, Spain
303
Madrid, 28046, Spain
282
Málaga, 29010, Spain
194
Valencia, 46026, Spain
263
Stoke-on-Trent, ST4 6QG, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sophia Majeed, PharmD, PhD
Corcept Therapeutics Incorporated
Central Study Contacts
Corcept Therapeutics Incorporated
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2022
First Posted
June 7, 2022
Study Start
November 15, 2022
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share