DAZALS

• Research type

  Research Study

• Full 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)

• IRAS ID

  1005853

• Contact name

  Susan Rinne

• Contact email

  srinne@corcept.com

• Sponsor organisation

  Corcept Therapeutics Incorporated

• Eudract number

  2021-005611-31

• Research summary

  Amyotrophic Lateral Sclerosis (ALS) is a devastating neurological disease & there is increasing evidence that ALS is associated with a significant distress, being linked to changes in hypothalamic–pituitary–adrenal axis activity & therefore a loss of cortisol circadian rhythmicity.
  The sponsor (Corcept Therapeutics) will be utilizing Dazucorilant/CORT113176 which is an investigational new molecular entity that is being developed for indications that may benefit from the modulation of cortisol activity.

  198 Participants (Male & female, ≥18 years) are expected to participate, across 30 sites in Europe and the USA. Participants will be randomized to receive 1:1:1 of CORT113176 (150 mg/day or 300 mg/day), or placebo.

  Participants will only enter the 4 week screening phase once the study has been explained by the study doctor, consent form has been signed & participant’s meets the eligibility criteria.
  Enrolled participants will be allowed to continue using ALS standard-of-care therapy. However, participants must be on a stable dose of riluzole for ≥30 days, or edaravone for ≥60 days prior to Screening.

  Participants will be randomized to either CORT113176 (150 or 300 mg/day) or matching placebo once daily for 24 weeks. Study drug will be orally administered once daily (4 capsules) with food & 8 oz (240 mL) of water at approximately the same time each day. Study visits will be once every three weeks. Some visits will be remote & conducted by phone.

  Participants that complete the double-blind treatment period & do not enter the open-label extension (OLE) will enter a 24-week follow-up period.

  Participants who complete the double-blind treatment period may enroll in an optional 24-week OLE & will receive CORT113176 (300 mg/day). Participants must enroll in the OLE within 28 days of the Week 24 visit of the double-blind treatment period & visits will be once every 4 weeks.

  Maximum duration in the double blind & OLE is 60 weeks.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  22/NE/0123

• Date of REC Opinion

  13 Oct 2022

• REC opinion

  Further Information Favourable Opinion