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.
This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to \<75 years) with classic CAH due to 21-OHD who have been on a stable regimen of GCs for at least 2 months to evaluate efficacy, safety, PK, and PD of atumelnant administered once per day. Following a 3- to 6-week Screening Period, eligible participants will enter the Treatment Period where they will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily (with an option for dose escalation to 120 mg once daily at Week 20) or placebo. A total of approximately 150 participants may be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Atumelnant, tablets, once daily by mouth
Placebo, tablets, once daily by mouth
Crinetics Study Site
Herston, Queensland, Australia
RECRUITINGCrinetics Study Site
Woolloongabba, Queensland, Australia
NOT_YET_RECRUITINGCrinetics Study Site
Adelaide, South Australia, Australia
NOT_YET_RECRUITINGProportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement.
Time frame: Week 32
Percent change from baseline of morning pre-GC A4
Time frame: Week 2
Percent change from baseline of morning pre-GC 17-OHP
Time frame: Week 32
Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement
Time frame: Week 32
Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN
Time frame: Week 32
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Crinetics Study Site
Parkville, Victoria, Australia
RECRUITINGCrinetics Study Site
Nedlands, Western Australia, Australia
RECRUITING