Phase
Condition
Congenital Adrenal Hyperplasia
Male Hormonal Deficiencies/abnormalities
Treatment
Atumelnant
Placebo
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 inthe 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, cortisoneacetate) at the time of informed consent.
If treated with mineralocorticoids (fludrocortisone), the dose should be stable forat least 1 month prior to Screening without orthostatic hypotension, and with serumsodium and potassium in the normal range.
If on estrogen therapy (any route), the dose must be stable for at least 3 monthsprior to Screening.
Exclusion
Exclusion Criteria:
Diagnosis of any form of CAH other than classic 21-OHD.
History of bilateral adrenalectomy, hypopituitarism, or other condition requiringchronic GC therapy.
Clinically significant medical condition or abnormal laboratory tests, as judged bythe 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 compliancewith medical instructions.
History of cancer excluding cured/treated dermal squamous or basal cell carcinoma orcervical carcinoma in situ.
Women who are pregnant or lactating or, if of childbearing potential, who areunwilling to use highly effective contraception as described in this study. Maleparticipants who are unwilling to use highly effective contraception as described inthis study.
Known history of, or concern for, risk of hypersensitivity reaction to atumelnant orany of its excipients.
Participants with an increased risk of developing adrenal insufficiency as judged bythe Investigator.
Severe erythrocytosis as judged by the Investigator.
Use of atumelnant prior to screening.
Study Design
Study Description
Connect with a study center
Crinetics Study Site
Buenos Aires, Buenos Aires F.D. C1012AAR
ArgentinaActive - Recruiting
Crinetics Study Site
CABA, Buenos Aires F.D. C1199ABB
ArgentinaActive - Recruiting
Crinetics Study Site
Córdoba, Córdoba Province X5000JRD
ArgentinaActive - Recruiting
Crinetics Study Site
Herston, Queensland 4029
AustraliaActive - Recruiting
Crinetics Study Site
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
Crinetics Study Site
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Crinetics Study Site
Parkville, Victoria 3050
AustraliaActive - Recruiting
Crinetics Study Site
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Crinetics Study Site
Vienna, 1090
AustriaActive - Recruiting
Crinetics Study Site
Curitiba, Paraná 33172
BrazilActive - Recruiting
Crinetics Study Site
Rio de Janeiro, Rio de Janeiro 20551-030
BrazilActive - Recruiting
Crinetics Study Site
Botucatu, São Paulo 18618-686
BrazilActive - Recruiting
Crinetics Study Site
São Paulo, São Paulo 05403-000
BrazilActive - Recruiting
Crinetics Study Site
Angers, 49933
FranceActive - Recruiting
Crinetics Study Site
Bron, 69500
FranceActive - Recruiting
Crinetics Study Site
Nantes, 44093 Cedex 1
FranceActive - Recruiting
Crinetics Study Site
Paris, 75013
FranceActive - Recruiting
Crinetics Study Site
Pessac, 33604
FranceActive - Recruiting
Crinetics Study Site
Vandœuvre-lès-Nancy, 54500
FranceActive - Recruiting
Crinetics Study Site
Munich, Bavaria 80336
GermanyActive - Recruiting
Crinetics Study Site
Würzburg, 97080
GermanyActive - Recruiting
Crinetics Study Site
Milan, Milano 20149
ItalyActive - Recruiting
Crinetics Study Site
Rozzano, Milano 20089
ItalyActive - Recruiting
Crinetics Study Site
Padova, Padova 35128
ItalyActive - Recruiting
Crinetics Study Site
Palermo, Palermo 90127
ItalyActive - Recruiting
Crinetics Study Site
Naples, 80131
ItalyActive - Recruiting
Crinetics Study Site
Roma, 00161
ItalyActive - Recruiting
Crinetics Study Site
Warsaw, Masovian Voivodeship 00-189
PolandActive - Recruiting
Crinetics Study Site
Lodz, Łódź Voivodeship 93-338
PolandActive - Recruiting
Crinetics Study Site
Gothenburg, 413 46
SwedenActive - Recruiting
Crinetics Study Site
Stockholm, 171 76
SwedenActive - Recruiting
Crinetics Study Site
London, NW1 2PG
United KingdomActive - Recruiting
Crinetics Study Site
Manchester, M20 4BX
United KingdomActive - Recruiting
Crinetics Study Site
Los Angeles, California 90027
United StatesActive - Recruiting
Crinetics Study Site
Atlanta, Georgia 30322
United StatesActive - Recruiting
Crinetics Study Site
Chicago, Illinois 60611
United StatesActive - Recruiting
Crinetics Study Site
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Crinetics Study Site
Minneapolis, Minnesota 55417
United StatesActive - Recruiting
Crinetics Study Site
Rochester, Minnesota 55905
United StatesActive - Recruiting
Crinetics Study Site
Pittsburgh, Pennsylvania 15213
United StatesActive - Recruiting
Crinetics Study Site
Dallas, Texas 75390
United StatesActive - Recruiting
Crinetics Study Site
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting

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