Clinical trial NCT05407324: Dazucorilant in Patients With Amyotrophic Lateral Sclerosis
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS, Amyotrophic Lateral Sclerosis
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-06-07
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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., completed 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 132-week OLE period.

Patients that complete the double-blind treatment period and who do not enter the OLE will enter the 132-week follow-up period.

Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥18 years of age with Sporadic or familial ALS
* If taking riluzole, edaravone, and/or sodium phenylbutyrate and taurursodiol, must be on a stable dose prior to Screening.

Exclusion Criteria:

* History of a clinically significant non-ALS neurologic disorder
* Inability to swallow capsules.
* Human immunodeficiency virus (HIV) or current chronic/active infection with hepatitis C virus or hepatitis B virus
* 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.

Primary outcomes:
measure: Change from Baseline to Week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R) total score.
timeFrame: Baseline to Week 24
measure: 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
Secondary outcomes:
measure: Change from Baseline to Week 24 in muscle strength (assessed using hand-held dynamometer).
timeFrame: Baseline to Week 24
measure: Change from Baseline to Week 24 in Percent Slow Vital Capacity
timeFrame: Baseline to Week 24
measure: Change from Baseline to Week 24 in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
timeFrame: Baseline to Week 24
measure: Time to Death
timeFrame: From randomization date to the date of death from any cause up to 156 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 062
state: Arizona
city: San Francisco
country: United States
facility: 278
state: California
city: Neptune
country: United States
facility: 287
state: New Jersey
city: New York
country: United States
facility: 353
state: New York
city: Leuven
country: Belgium
facility: 108
city: Hamilton
country: Canada
facility: 425
state: Ontario
city: Montréal
country: Canada
facility: 273
state: Quebec
city: Bron
country: France
facility: 422
city: Lille
country: France
facility: 258
city: Limoges
country: France
facility: 257
city: Marseille
country: France
facility: 261
city: Montpellier
country: France
facility: 423
city: Nice
country: France
facility: 259
city: Paris
country: France
facility: 262
city: Tours
country: France
facility: 256
city: Berlin
country: Germany
facility: 255
city: Bonn
country: Germany
facility: 270
city: Dresden
country: Germany
facility: 268
city: Hannover
country: Germany
facility: 260
city: Jena
country: Germany
facility: 265
city: München
country: Germany
facility: 386
city: Rostock
country: Germany
facility: 267
city: Ulm
country: Germany
facility: 269
city: Dublin
country: Ireland
facility: 253
city: Utrecht
country: Netherlands
facility: 264
city: Bydgoszcz
country: Poland
facility: 283
city: Kraków
country: Poland
facility: 385
city: Warszawa
country: Poland
facility: 254
city: Warszawa
country: Poland
facility: 274
city: Barcelona
country: Spain
facility: 302
city: Barcelona
country: Spain
facility: 115
city: Madrid
country: Spain
facility: 303
city: Málaga
country: Spain
facility: 282
city: Valencia
country: Spain
facility: 194
city: Stoke on Trent
country: United Kingdom
facility: 263
Study officials:
affiliation: Corcept Therapeutics
name: Grace Mann, PhD
role: STUDY_DIRECTOR
References: