The Calm-CAH Study
Enrolling Ages 18 to 74

The Calm-CAH Study is evaluating the safety and effectiveness of an investigational study drug, atumelnant, whether it may reduce the dosage needed for steroid medications like glucocorticoids (GCs), and how it may help manage symptoms of CAH.

About the Study

The Calm-CAH Study is currently enrolling adults diagnosed with classic CAH. To learn more and see if you may be eligible to take part, talk to your doctor today.

Duration

The study will last about 10 months with up to 14 study visits, 4 of which may be done by telephone.

Randomized study

You will be randomly assigned, like drawing straws, to receive the study drug or a placebo, which is a substance that looks just like the study drug but does not contain any medicine.

Receive the study drug

You will have a higher chance of receiving the study drug (about 66%) than the placebo (about 33%).

Remain on your current medication

Throughout the study, you will be able to remain on your GCs as directed by your physician, but efforts will be made to reduce the dosage needed, based on how you are feeling. A team of medical professionals will monitor your health throughout the study.

About the study drug

The assigned study treatment is a tablet that will be taken orally once daily in the evening as instructed by your study doctor.

No cost to participants

The assigned study treatment, study lab tests, imaging (DXA scan [bone density test], ultrasound in male participants, and optional CT scan), study procedures, and safety assessments are provided at no cost to you. Additionally, if enrolled, reasonable costs for travel may be reimbursed when you visit the research center for study visits.

If you complete the Calm-CAH Study, you may be eligible to enroll in a long-term extension study where you will be guaranteed to receive the study drug, even if you had previously received the placebo in the Calm-CAH Study.

Who May Qualify

If you are interested in joining the Calm-CAH Study, you must:

Be 18 to 74 years of age
Have received a diagnosis of classic CAH
Be on a stable GC regimen (for example: modified-release hydrocortisone, cortisone acetate, prednisolone, prednisone, methylprednisolone, dexamethasone)

Additional requirements apply, which the study team will discuss with you.

Calm-CAH Study Participation

The Calm-CAH Study is made up of the following periods:

Screening period

The study team will perform assessments, such as blood and urine sample collections, to make sure the study is a good match for you. There will be 2 screening visits at the research center.

Treatment period

If you qualify and decide to participate, you will take your assigned study treatment once daily in the evening as instructed by your study doctor. There will be 10 study visits, 3 of which may be completed by telephone.

If you complete the treatment period, you may be eligible to enroll in a long-term extension study where you are guaranteed to receive the study drug, even if you previously received the placebo in the Calm-CAH Study.

Follow-up period

You will stop taking your assigned study treatment and have 2 follow-up visits so the study team can monitor your health. One visit may be completed by telephone.

The Calm-CAH Study Enrolling Ages 18 to 74