Phase 2 / Phase 3: testing Atumelnant for Congenital Adrenal Hyperplasia
This study wants to measure the safety, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
Official registry: https://clinicaltrials.gov/study/NCT07159841 · Crinetics Pharmaceuticals Inc. · enrollment listed as 153
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Atumelnant, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
They plan to enroll about 153 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension
Interventions: Atumelnant, Placebo
Primary outcome (registry wording): Change from baseline in morning serum androstenedione (A4) (Part A)
Who it is for (from inclusion criteria)
- Ages 1 Year to 17 Years
- Part A and B participants are eligible to be included in the study only if all of the following criteria apply:
- Participants must have an elevated morning serum A4 level \>ULN during Screening obtained prior to morning glucocorticoid (GC) administration
- Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening
- Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period
- Biochemical euthyroidism as determined by the Investigator
- Part C who can join require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age
Who the registry excludes
- Part A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:
- Diagnosis of any form of CAH other than classic 21-OHD
- Participants treated with other GCs within 30 days of Screening
- Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone
- Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting
- Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
Public study contact (from the registry)
Crinetics Clinical Trials
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
53 listed- Children's Hospital Los Angeles — Los Angeles, California (recruiting)
- UCSF Ron Conway Gateway Medical Building — San Francisco, California (recruiting)
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois (recruiting)
- Boston's Children's Hospital — Boston, Massachusetts (recruiting)
- University of Michigan — Ann Arbor, Michigan (recruiting)
- University of Minnesota — Minneapolis, Minnesota (recruiting)
- Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey (recruiting)
- Icahn School of Medicine at Mount Sinai-Mount Sinai Hospital — New York, New York (recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania (recruiting)
- Cook Children's Health Care System — Fort Worth, Texas (recruiting)
- University of Virginia Health System — Charlottesville, Virginia (recruiting)
+ 42 sites outside the US on the same record
FAQ about this NCT record
Is NCT07159841 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07159841?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07159841?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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