A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- Diagnosis of any form of CAH other than classic 21-OHD.
- History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
- Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
- Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
- Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
- Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.
- Severe erythrocytosis as judged by the Investigator.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT07144163
Intervention or treatment
DRUG: Atumelnant
DRUG: Placebo
Conditions
- Congenital Adrenal Hyperplasia
- Classic Congenital Adrenal Hyperplasia
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Research sites nearby
Closest Location:
Crinetics Study Site
Select from list below to view details:
Crinetics Study Site
Herston, Queensland, Australia
Crinetics Study Site
Woolloongabba, Queensland, Australia
Crinetics Study Site
Adelaide, South Australia, Australia
Crinetics Study Site
Parkville, Victoria, Australia
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Who is running the clinical trial?
Crinetics Pharmaceuticals Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Treatment
| Drug: Atumelnant |
PLACEBO_COMPARATOR: Placebo
| Drug: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. | Not Specified | Week 32 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline of morning pre-GC A4 | Not Specified | Week 2 |
| Percent change from baseline of morning pre-GC 17-OHP | Not Specified | Week 32 |
| Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement | Not Specified | Week 32 |
| Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN | Not Specified | Week 32 |
References
Clinical Trials Gov: A Study to Evaluate Atumelnant in Adults With Congenital Adrenal HyperplasiaOther trials to consider
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