Recruiting NCT07144163
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atumelnant, Placebo.
- Who it may be relevant to
- Registry conditions: Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia. Basic parameters: 18 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Brazil +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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 (Calm-CAH)
Overview
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.
Detailed description
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.
Interventions
- Drug Atumelnant
Atumelnant, tablets, once daily by mouth - Drug Placebo
Placebo, tablets, once daily by mouth
Primary outcome measures
- Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. [Time frame: Week 32]
Secondary outcome measures (4)
- Percent change from baseline of morning pre-GC A4 [Time frame: Week 2]
- Percent change from baseline of morning pre-GC 17-OHP [Time frame: Week 32]
- Proportion of participants with morning pre-GC A4 ≤ ULN who are on physiologic GC replacement [Time frame: Week 32]
- Percent change from baseline in GC daily dose when morning post-GC A4 ≤ ULN [Time frame: Week 32]
Eligibility criteria
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.
- 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, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.
- 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.
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.
- Use of atumelnant prior to screening.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- Crinetics Study Site — Los Angeles
- Crinetics Study Site — Atlanta
- Crinetics Study Site — Chicago
- Crinetics Study Site — Baltimore
- Crinetics Study Site — Ann Arbor
- Crinetics Study Site — Minneapolis
- Crinetics Study Site — Rochester
- Crinetics Study Site — Pittsburgh
- … and 2 more centers
Brazil · 8 centers
- Crinetics Study Site — Fortaleza
- Crinetics Study Site — Curitiba
- Crinetics Study Site — Rio de Janeiro
- Crinetics Study Site — Rio de Janeiro
- Crinetics Study Site — Porto Alegre
- Crinetics Study Site — Botucatu
- Crinetics Study Site — São Paulo
- Crinetics Study Site — São Paulo
Italy · 8 centers
- Crinetics Study Site — Milan
- Crinetics Study Site — Milan
- Crinetics Study Site — Rozzano
- Crinetics Study Site — Modena
- Crinetics Study Site — Padova
- Crinetics Study Site — Palermo
- Crinetics Study Site — Naples
- Crinetics Study Site — Roma
France · 6 centers
- Crinetics Study Site — Angers
- Crinetics Study Site — Bron
- Crinetics Study Site — Nantes
- Crinetics Study Site — Paris
- Crinetics Study Site — Pessac
- Crinetics Study Site — Vandœuvre-lès-Nancy
Argentina · 5 centers
- Crinetics Study Site — Buenos Aires
- Crinetics Study Site — Buenos Aires
- Crinetics Study Site — CABA
- Crinetics Study Site — CABA
- Crinetics Study Site — Córdoba
Australia · 5 centers
- Crinetics Study Site — Herston
- Crinetics Study Site — Woolloongabba
- Crinetics Study Site — Adelaide
- Crinetics Study Site — Parkville
- Crinetics Study Site — Nedlands
Poland · 3 centers
- Crinetics Study Site — Poznan
- Crinetics Study Site — Warsaw
- Crinetics Study Site — Lodz
United Kingdom · 3 centers
- Crinetics Study Site — Cardiff
- Crinetics Study Site — London
- Crinetics Study Site — Manchester
Germany · 2 centers
- Crinetics Study Site — Munich
- Crinetics Study Site — Würzburg
Sweden · 2 centers
- Crinetics Study Site — Gothenburg
- Crinetics Study Site — Stockholm
Austria · 1 center
- Crinetics Study Site — Vienna
Netherlands · 1 center
- Crinetics Study Site — Leiden
Saudi Arabia · 1 center
- Crinetics Study Site — Riyadh
Identifiers
NCT: NCT07144163 · CRN04894-12 · 2024-519579-24-00