Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
NCT ID: NCT04490915
Last Updated: 2025-02-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
182 participants
INTERVENTIONAL
2020-12-16
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo capsule, administered orally, twice daily for 24 weeks, followed by active treatment with crinecerfont for at least 1 year.
Crinecerfont
CRF type 1 receptor antagonist
Placebo
Non-active dosage form
Crinecerfont
Crinecerfont capsule, administered orally, twice daily for 24 weeks during the placebo-controlled treatment period, followed by active treatment with crinecerfont for at least 1 year.
Crinecerfont
CRF type 1 receptor antagonist
Interventions
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Crinecerfont
CRF type 1 receptor antagonist
Placebo
Non-active dosage form
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
3. Be on a stable steroid regimen.
4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study.
Exclusion Criteria
2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
3. Have a clinically significant unstable medical condition or chronic disease other than CAH.
4. Have a history of cancer unless considered cured.
5. Are pregnant.
6. Have a known history of clinically significant arrhythmia or abnormalities on ECG.
7. Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists.
8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
9. Have current substance dependence, or current substance (drug) or alcohol abuse.
10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.
18 Years
ALL
No
Sponsors
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Neurocrine Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Lead
Role: STUDY_DIRECTOR
Neurocrine Biosciences
Locations
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Neurocrine Clinical Site
Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Aurora, Colorado, United States
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Atlanta, Georgia, United States
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Indianapolis, Indiana, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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St Louis, Missouri, United States
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Great Neck, New York, United States
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New York, New York, United States
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Winston-Salem, North Carolina, United States
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Tulsa, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Seattle, Washington, United States
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Graz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Leuven, , Belgium
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Halifax, Nova Scotia, Canada
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Hradec Králové, , Czechia
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Angers, , France
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Grenoble, , France
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Le Kremlin-Bicêtre, , France
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Nantes, , France
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Paris, , France
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Paris, , France
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Dresden, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Leipzig, , Germany
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Munich, , Germany
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Athens, , Greece
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Afula, , Israel
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Beersheba, , Israel
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Petah Tikva, , Israel
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Tel Aviv, , Israel
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Ancona, , Italy
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Bologna, , Italy
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Florence, , Italy
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Messina, , Italy
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Milan, , Italy
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Milan, , Italy
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Naples, , Italy
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Padua, , Italy
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Roma, , Italy
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Leiden, , Netherlands
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Krakow, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Porto, , Portugal
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Belgrade, , Serbia
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Madrid, , Spain
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Seville, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Cardiff, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Salford, , United Kingdom
Countries
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References
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Auchus RJ, Hamidi O, Pivonello R, Bancos I, Russo G, Witchel SF, Isidori AM, Rodien P, Srirangalingam U, Kiefer FW, Falhammar H, Merke DP, Reisch N, Sarafoglou K, Cutler GB Jr, Sturgeon J, Roberts E, Lin VH, Chan JL, Farber RH; CAHtalyst Adult Trial Investigators. Phase 3 Trial of Crinecerfont in Adult Congenital Adrenal Hyperplasia. N Engl J Med. 2024 Aug 8;391(6):504-514. doi: 10.1056/NEJMoa2404656. Epub 2024 Jun 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Study website - CAHtalyst Study
Other Identifiers
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2019-004873-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-509171-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
NBI-74788-CAH3003
Identifier Type: -
Identifier Source: org_study_id
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