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A Study to Evaluate Atumelnant in Adults with Congenital Adrenal Hyperplasia

  • Status
    Accepting Candidates
  • Age
    18 Years - 74 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Description

This is a Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study in adult participants (male or female age ≥18 to

Details

Full study title A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants with Classic Congenital Adrenal Hyperplasia
Protocol number OCR49505
ClinicalTrials.gov ID NCT07144163
Phase Phase 3

Eligibility

Inclusion Criteria:

  1. Male or female, between ≥18 to ULN and treated with 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.

  2. 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.

  3. 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.

  4. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.

Exclusion Criteria:

  1. Diagnosis of any form of CAH other than classic 21-OHD.

  2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.

  3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.

  4. 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.

  5. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.

  6. 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.

  7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.

  8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.

  9. Severe erythrocytosis as judged by the Investigator.

  10. Use of atumelnant prior to screening.

Lead researcher

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    1

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  2. Step
    2

    Get screened to confirm eligibility

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