A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.

• Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.

• Have classic CAH due to 21-OHD confirmed by the Investigator and approved by the Medical Monitor.

• Participants with levels of morning serum A4 as follows:

‣ A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses

⁃ OR normal A4 (above mid-range to ≤ULN) and treated with ≥15 mg/m2/day GC doses

⁃ OR A4 \>ULN and treated with ≥11 mg/m2/day GC doses.

• On a stable (defined as no dose change of \>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.

• If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 2 months prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.

• If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.

Locations
Other Locations
Australia
Crinetics Study Site
NOT_YET_RECRUITING
Adelaide
Crinetics Study Site
RECRUITING
Herston
Crinetics Study Site
RECRUITING
Nedlands
Crinetics Study Site
RECRUITING
Parkville
Crinetics Study Site
NOT_YET_RECRUITING
Woolloongabba
Contact Information
Primary
Crinetics Clinical Trials
clinicaltrials@crinetics.com
833-827-9741
Time Frame
Start Date: 2025-12-11
Estimated Completion Date: 2027-05
Participants
Target number of participants: 150
Treatments
Experimental: Treatment
Atumelnant tablet, administered orally, once daily for 32 weeks.
Placebo_comparator: Placebo
Matching placebo, administered orally, once daily for 32 weeks.
Sponsors
Leads: Crinetics Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov