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New treatment option for Congenital Adrenal Hyperplasia
Official title A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
ClinicalTrials.gov ID: NCT07144163
What this study is testing
What is Atumelnant?
Atumelnant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for congenital adrenal hyperplasia.
Also referred to as CRN04894.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 74
You may be able to join if
- 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.
- Participants with Visit 2 levels of morning serum A4 as follows:
- A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- Participants with Visit 2 levels of morning serum A4 as follows:
- A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
- OR normal A4 (\>0.5xULN to ≤1xULN) and treated with ≥14 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...
- If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month 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.
- 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...
- 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.
- Use of atumelnant prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Milwaukee, Wisconsin, United States
- Buenos Aires, Buenos Aires F.D., Argentina
- CABA, Buenos Aires F.D., Argentina
- Córdoba, Córdoba Province, Argentina
- Herston, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Parkville, Victoria, Australia
- Nedlands, Western Australia, Australia
- Vienna, Austria
- Curitiba, Paraná, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
+ 22 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; Ann Arbor, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States and 36 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.