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A Study to Evaluate Atumelnant in Adults with Congenital Adrenal Hyperplasia
EU CTIS ID: 2024-519579-24-00
What this study is testing
To evaluate efficacy of atumelnant, compared with placebo, in reducing daily GC dosage while maintaining adrenal androgen control at the end of the 32-week Treatment Period
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male or female, between ≥18 to <75 years of age at the time of signing the ICF.
- 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
- 3. Have classic CAH due to 21-OHD confirmed by the Investigator and approved by the Medical Monitor.
- 4. Participants with levels of morning serum A4 as follows: A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses in hydrocortisone equivalents OR normal A4 (above mid-range to ≤ULN) and treated with ≥15 mg/m2/day GC doses in hydrocortisone equivalents OR A4 >ULN and treated with ≥11 mg/m2 /day GC doses in hydrocortisone equivalents.
- 5. On a stable (defined as no dose change of >X mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone, dexamethasone) at the time of informed consent.
- 6. 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.
You likely can't join if
- Refer to section 5.3 of the Protocol for the full exclusion criteria.
See the full eligibility criteria
- 1. Male or female, between ≥18 to <75 years of age at the time of signing the ICF.
- 2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
- 3. Have classic CAH due to 21-OHD confirmed by the Investigator and approved by the Medical Monitor.
- 4. Participants with levels of morning serum A4 as follows: A4 >ULN and treated with <11 mg/m2/day (physiologic) GC doses in hydrocortisone equivalents OR normal A4 (above mid-range to ≤ULN) and treated with ≥15 mg/m2/day GC doses in hydrocortisone equivalents OR A4 >ULN and treated with ≥11 mg/m2 /day GC doses in hydrocortisone equivalents.
- 5. On a stable (defined as no dose change of >X mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone, dexamethasone) at the time of informed consent.
- 6. 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.
- 7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.
- 8. Female participants who engage in heterosexual intercourse must: a. Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), OR b. Agree to use a highly effective or a clinically acceptable method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. c. See Section 12.1.4 for additional contraception guidance.
- 9. Male participants who engage in heterosexual intercourse must: a. Agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile [ie, vasectomy with a confirmed absence of sperm in ejaculate]) OR b. Agree to remain abstinent on a long-term and persistent basis during the study and until at least 2 weeks after the last dose of study drug. c. Agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug. d. See Section 12.1.4 for additional contraception guidance.
- Refer to section 5.3 of the Protocol for the full exclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Brazil
- Japan
- United States
- Canada
- Saudi Arabia
- Australia
- Argentina
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Brazil; Japan; United States; Canada; Saudi Arabia and 3 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 EU CTIS; the study team decides eligibility.