Clinical trial • Phase III • Endocrinology|Rare Disease
CRINECERFONT for Classic congenital adrenal hyperplasia
Phase III trial of CRINECERFONT for Classic congenital adrenal hyperplasia.
Overview
- Trial Therapeutic Area
- Endocrinology|Rare Disease
- Trial Disease
- Classic congenital adrenal hyperplasia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 07-06-2024
- First CTIS Authorization Date
- 11-07-2024
Trial design
Randomised, open-label, placebo (crinecerfont placebo for oral capsules) as comparator arm; active arm: crinecerfont (nbi-74788) 100 mg twice daily (bid).-controlled Phase III trial across 31 sites in Austria, Belgium, Bulgaria and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Placebo (Crinecerfont placebo for oral capsules) as comparator arm; active arm: Crinecerfont (NBI-74788) 100 mg twice daily (bid).
- Target Sample Size
- 83
Eligibility
Recruits 83 Vulnerable population selected. All participants must provide written informed consent. Enrollment restricted to adults (≥18 years) so no child assent procedures are described. Subject information and informed consent forms and related materials are provided (multiple country-specific versions listed in the trial documents)..
- Pregnancy Exclusion
- Females who are pregnant or lactating.
- Vulnerable Population
- Vulnerable population selected. All participants must provide written informed consent. Enrollment restricted to adults (≥18 years) so no child assent procedures are described. Subject information and informed consent forms and related materials are provided (multiple country-specific versions listed in the trial documents).
Inclusion criteria
- {"criterion_text":"- Subjects must provide written informed consent.\n- Be a female or male at least 18 years of age.\n- Have a medically confirmed diagnosis of classic 21-hydroxylase deficiency.\n- Be on a stable, supraphysiologic glucocorticoid dose regimen that has been stable for at least 1 month prior to screening.\n- If treated with fludrocortisone, dose should be stable for at least 1 month prior to screening with an upright plasma renin activity (PRA) during screening that is not greater than ULN on the subject's usual sodium intake. If PRA is >ULN, the subject must have systolic blood pressure >100 mmHg, without orthostatic hypotension, and with serum sodium and potassium in the normal range.\n- Female subjects of childbearing potential with fertile male partners must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study drug, whichever is longer. A female who is not of childbearing potential must meet one of the following:"}
Exclusion criteria
- {"criterion_text":"- Have a known or suspected diagnosis of any of the other forms of classic CAH including 11-β-hydroxylase deficiency, 17-α-hydroxylase deficiency, 3-β-hydroxysteroid dehydrogenase deficiency, P450 sidechain cleavage deficiency, or P450 oxidoreductase deficiency.\n- Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic therapy with oral glucocorticoids, or requiring chronic therapy with inhaled glucocorticoids that based on dose and hormone profile the investigator deems would yield significant systemic exposure interfering with study endpoints.\n- Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease [excluding CAH]) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.\n- History of malignancy, unless successfully treated with curative intent and considered to be cured.\n- Have a known history of clinically concerning cardiac arrhythmia (including long QT syndrome) or prolongation of screening (pretreatment) QT interval corrected for heart rate using Fridericia's correction (QTcF) of >450 msec (males) or >470 msec (females).\n- Known sensitivity (ie, hypersensitivity) or allergy to any corticotropinreleasing hormone (CRH) receptor antagonist.\n- Have evidence of chronic renal or liver disease Used any active investigational drug within 30 days or 5 half-lives (whichever is longer) before screening, or plans to use an investigational drug (other than the study drug) during the study.\n- Females who are pregnant or lactating.\n- Are using any excluded concomitant medication and cannot discontinue use of these medications for the duration of the study (also refer to Section 9.9.1): • Orally administered glucocorticoids for indications other than CAH. • Strong inducers of CYP3A4 or CYP2B6 except topically administered medications. • Medications that affect cortisol or glucocorticoid metabolism (eg, phenytoin, mitotane, phenobarbital, strong CYP3A4 inhibitors such as ketoconazole, clarithromycin, cholestyramine, certain antivirals) except topically administered medications. • Aromatase inhibitors (eg, anastrozole, letrozole, testolactone)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent change from baseline in glucocorticoid daily dose (in hydrocortisone equivalents adjusted for BSA [mg/m2/day]) at Week 24.","definition_or_measurement_approach":"Percent change from baseline in glucocorticoid daily dose measured in hydrocortisone equivalents adjusted for body surface area (mg/m2/day), assessed at Week 24."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline in serum androstenedione at Week 4.","definition_or_measurement_approach":"Change from baseline in serum androstenedione level measured at Week 4."}
- {"endpoint_text":"- Achievement of a reduction in glucocorticoid daily dose to physiologic levels Week 24.","definition_or_measurement_approach":"Proportion/occurrence of subjects whose glucocorticoid daily dose is reduced to physiologic levels by Week 24."}
- {"endpoint_text":"- Changes from baseline in HOMA-IR, weight, and fat mass at Week 24","definition_or_measurement_approment":"Changes from baseline in HOMA-IR, body weight, and fat mass assessed at Week 24."}
Recruitment
- Planned Sample Size
- 83
- Recruitment Window Months
- 80
- Consent Approach
- Written informed consent is required from all participants ("Subjects must provide written informed consent."). Participants are adults (≥18 years) so no assent is described. Subject information and informed consent forms (including pregnancy, genetic testing, data protection variants) are provided in multiple country-specific versions as listed in the trial documents.
Geography
- Total Number Of Sites
- 31
- Total Number Of Participants
- 99
Austria
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 348
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
- Department Name
- Department of Internal Medicine III
- Principal Investigator Name
- Florian Kiefer
- Principal Investigator Email
- florian.kiefer@meduniwien.ac.at
- Contact Person Name
- Florian Kiefer
- Contact Person Email
- florian.kiefer@meduniwien.ac.at
- Site Name
- Medical University Of Graz
- Department Name
- Klinische Abteilung für Endokrinologie und Diabetologie Universitätsklinik für Innere Medizin
- Principal Investigator Name
- Stefan Pilz
- Principal Investigator Email
- stefan.pilz@medunigraz.at
- Contact Person Name
- Stefan Pilz
- Contact Person Email
- stefan.pilz@medunigraz.at
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-07-2024
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 337
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- UZ Leuven
- Department Name
- University Hospital Leuven
- Principal Investigator Name
- Leen Antonio
- Principal Investigator Email
- leen.antonio@uzleuven.be
- Contact Person Name
- Leen Antonio
- Contact Person Email
- leen.antonio@uzleuven.be
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 340
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
- Department Name
- First Clinic
- Principal Investigator Name
- Ralitsa Robeva
- Principal Investigator Email
- rali_robeva@yahoo.com
- Contact Person Name
- Ralitsa Robeva
- Contact Person Email
- rali_robeva@yahoo.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 344
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. Interní klinika
- Principal Investigator Name
- Jan Čáp
- Principal Investigator Email
- capj@lfhk.cuni.cz
- Contact Person Name
- Jan Čáp
- Contact Person Email
- capj@lfhk.cuni.cz
France
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 343
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- -
- Principal Investigator Name
- Justine Cristante
- Principal Investigator Email
- jcristante@chu-grenoble.fr
- Contact Person Name
- Justine Cristante
- Contact Person Email
- jcristante@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Endocrinology
- Principal Investigator Name
- Philippe Touraine
- Principal Investigator Email
- philippe.touraine@aphp.fr
- Contact Person Name
- Philippe Touraine
- Contact Person Email
- philippe.touraine@aphp.fr
- Site Name
- Centre Hospitalier Regional D'Angers
- Department Name
- CHU Angers
- Principal Investigator Name
- Patrice Rodien
- Principal Investigator Email
- parodien@chu-angers.fr
- Contact Person Name
- Patrice Rodien
- Contact Person Email
- parodien@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Endocrinology
- Principal Investigator Name
- Delphine Drui
- Principal Investigator Email
- Delphine.DRUI@chu-nantes.fr
- Contact Person Name
- Delphine Drui
- Contact Person Email
- Delphine.DRUI@chu-nantes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Endocrinology
- Principal Investigator Name
- Jerome Bertherat
- Principal Investigator Email
- jerome.bertherat@aphp.fr
- Contact Person Name
- Jerome Bertherat
- Contact Person Email
- jerome.bertherat@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service of endocrinology adults BuldingBarré-Sinoussi
- Principal Investigator Name
- Jacques Young
- Principal Investigator Email
- jacques.young@aphp.fr
- Contact Person Name
- Jacques Young
- Contact Person Email
- jacques.young@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 04-07-2024
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 344
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Endocrinology department
- Principal Investigator Name
- Nicole Reisch
- Principal Investigator Email
- nicole.reisch@med.uni-muenchen.de
- Contact Person Name
- Nicole Reisch
- Contact Person Email
- nicole.reisch@med.uni-muenchen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Endocrinology - Diabetology
- Principal Investigator Name
- Jörg Bojunga
- Principal Investigator Email
- joerg.bojunga@ukffm.de
- Contact Person Name
- Jörg Bojunga
- Contact Person Email
- joerg.bojunga@ukffm.de
Greece
- Earliest CTIS Part Ii Submission Date
- 23-09-2024
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 266
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- A' Department of Internal Medicine NHS – Endocrinology Clinic
- Principal Investigator Name
- Zoe Efstathiadou
- Principal Investigator Email
- zefsta@hotmail.com
- Contact Person Name
- Zoe Efstathiadou
- Contact Person Email
- zefsta@hotmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- A' Propaepeudic Department of Internal Medicine - Endocrinology University Clinic
- Principal Investigator Name
- Gregory Kaltsas
- Principal Investigator Email
- gregory.kaltsas@gmail.com
- Contact Person Name
- Gregory Kaltsas
- Contact Person Email
- gregory.kaltsas@gmail.com
- Site Name
- Evangelismos S.A.
- Department Name
- Endocrinology Department – Diabetes and Metabolism (AHEPA building, 8th floor),
- Principal Investigator Name
- Vassiliadi Dimitra
- Principal Investigator Email
- d.a.vassiliadi@gmail.com
- Contact Person Name
- Vassiliadi Dimitra
- Contact Person Email
- d.a.vassiliadi@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 10-07-2024
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 341
- Number Of Sites
- 8
- Number Of Participants
- 36
Sites
- Site Name
- University Of Florence
- Department Name
- Endocrinology Unit, Dept. of Experimental and Clinical Biomedical Sciences "Mario Serio"
- Principal Investigator Name
- Mario Maggi
- Principal Investigator Email
- mario.maggi@unifi.it
- Contact Person Name
- Mario Maggi
- Contact Person Email
- mario.maggi@unifi.it
- Site Name
- Azienda Unita Sanitaria Locale Di Bologna
- Department Name
- UOC di Endocinologia
- Principal Investigator Name
- Uberto Pagotto
- Principal Investigator Email
- uberto.pagotto@unibo.it
- Contact Person Name
- Uberto Pagotto
- Contact Person Email
- uberto.pagotto@unibo.it
- Site Name
- Azienda Ospedaliera di Padova
- Department Name
- Department of Medicine DIMED
- Principal Investigator Name
- Mattia Barbot
- Principal Investigator Email
- mattia.barbot@aopd.veneto.it
- Contact Person Name
- Mattia Barbot
- Contact Person Email
- mattia.barbot@aopd.veneto.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Department of Pediatric Endocrinology.
- Principal Investigator Name
- Gianni Russo
- Principal Investigator Email
- russo.gianni@hsr.it
- Contact Person Name
- Gianni Russo
- Contact Person Email
- russo.gianni@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Policlinico Umberto I
- Department Name
- Clinica medica 5, department of Experimental Medicine
- Principal Investigator Name
- Andrea Isidori
- Principal Investigator Email
- andrea.isidori@uniroma1.it
- Contact Person Name
- Andrea Isidori
- Contact Person Email
- andrea.isidori@uniroma1.it
- Site Name
- Istituto Auxologico Italiano IRCCS
- Department Name
- Department of Endocrine and Metabolic Diseases
- Principal Investigator Name
- Luca Persani
- Principal Investigator Email
- luca.persani@unimi.it
- Contact Person Name
- Luca Persani
- Contact Person Email
- luca.persani@unimi.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica di Endocrinologia, Dipartimento di Specialità Mediche e Chirurgiche
- Principal Investigator Name
- Gilberta Giacchetti
- Principal Investigator Email
- gilberta.giacchetti@ospedaliriuniti.marche.it
- Contact Person Name
- Gilberta Giacchetti
- Contact Person Email
- gilberta.giacchetti@ospedaliriuniti.marche.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- Department of Clinical Medicine and Surgery, section of Endocrinology
- Principal Investigator Name
- Rosario Pivonello
- Principal Investigator Email
- rosario.pivonello@unina.it
- Contact Person Name
- Rosario Pivonello
- Contact Person Email
- rosario.pivonello@unina.it
Poland
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 328
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o.
- Department Name
- -
- Principal Investigator Name
- Grzegorz Sokołowski
- Principal Investigator Email
- grzegorz.sokolowski@dobrylekarz.com.pl
- Contact Person Name
- Grzegorz Sokołowski
- Contact Person Email
- grzegorz.sokolowski@dobrylekarz.com.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- -
- Principal Investigator Name
- Marek Ruchala
- Principal Investigator Email
- mruchala@ump.edu.pl
- Contact Person Name
- Marek Ruchala
- Contact Person Email
- mruchala@ump.edu.pl
- Site Name
- Szpital Bielanski Im.Ks.Jerzego Popieluszki Samodzielny Publiczny Zaklad Opieki Zdrowotnej
- Department Name
- -
- Principal Investigator Name
- Lucyna Bednarek-Papierska
- Principal Investigator Email
- lbednarek@cmkp.edu.pl
- Contact Person Name
- Lucyna Bednarek-Papierska
- Contact Person Email
- lbednarek@cmkp.edu.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 11-06-2025
- Processing Time Days
- 341
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- Sao Joao University Hospital Center
- Department Name
- Endocrinology Department
- Principal Investigator Name
- Duarte Pigniatelli
- Principal Investigator Email
- dpignatelli@yahoo.com
- Contact Person Name
- Duarte Pigniatelli
- Contact Person Email
- dpignatelli@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 05-07-2024
- Latest Decision Or Authorization Date
- 13-06-2025
- Processing Time Days
- 343
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Endocrinology and Nutrition Department
- Principal Investigator Name
- Manuel Luque Ramírez
- Principal Investigator Email
- manuel.luque@salud.madrid.org
- Contact Person Name
- Manuel Luque Ramírez
- Contact Person Email
- manuel.luque@salud.madrid.org
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- -
- Principal Investigator Name
- Miguel Mangas Cruz
- Principal Investigator Email
- mangel.mangas.sspa@juntadeandalucia.es
- Contact Person Name
- Miguel Mangas Cruz
- Contact Person Email
- mangel.mangas.sspa@juntadeandalucia.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 16-06-2025
- Processing Time Days
- 348
- Number Of Sites
- 1
- Number Of Participants
- 4
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Endocrinology, Metabolism and Diabetes
- Principal Investigator Name
- Henrik Falhammar
- Principal Investigator Email
- henrik.falhammar@ki.se
- Contact Person Name
- Henrik Falhammar
- Contact Person Email
- henrik.falhammar@ki.se
Sponsor
Primary sponsor
- Full Name
- Neurocrine Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Worldwide Clinical Trials Holdings Inc.
- Responsibilities
- Medical monitoring, Site Management, Site Activation including Negotiation of site clinical trial agreements, Trial Master File, Clinical Assessment Technologies, Risk Based Quality Management (RBQM), Drug Safety, Grant and Vendor Payments
- Name
- Syneos Health Inc.
- Responsibilities
- PK Analysis
- Name
- Medpace Inc.
- Responsibilities
- Analysis of urine androgen metabolites
- Name
- Bioclinica Inc.
- Responsibilities
- Medical image review and analysis: DXA, ultrasound , Blood pressure equipment provider
- Name
- Medpace Reference Laboratories LLC
- Responsibilities
- Processing and analysis of blood and urine samples, Clinical hematology, chemistry Biomarker analyses
- Name
- Quest Diagnostics Nichols Institute Inc.
- Responsibilities
- Analysis of 17-OHP, PRA, ASD, CYP21A2, Total testosterone
Third parties
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Medical image review and analysis: DXA, ultrasound , Blood pressure equipment provider","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Quest Diagnostics Nichols Institute Inc.","duties_or_roles":"Analysis of 17-OHP, PRA, ASD, CYP21A2, Total testosterone","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Processing and analysis of blood and urine samples, Clinical hematology, chemistry Biomarker analyses","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"Data Monitoring Committee (DMC)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"e-PRO (electronic patient-reported outcome) related services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medpace Inc.","duties_or_roles":"Analysis of urine androgen metabolites","organisation_type":"Pharmaceutical company"}
- {"country":"Israel","full_name":"Trialog Clinical Trials Ltd.","duties_or_roles":"Depot for IP distribution and return in Israel","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"PK Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"electronic patient-reported outcome (e-PRO) and related services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Home health services, Direct-to-Patient (DTP) IP shipments","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Clinical hematology, chemistry Biomarker analyses, Processing and analysis of blood, urine samples","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"Biotec Services International Limited","duties_or_roles":"IP distribution and labeling","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Millmount Healthcare Limited","duties_or_roles":"IP distribution and labeling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Andersonbrecon Inc.","duties_or_roles":"IP distribution and labeling","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Worldwide Clinical Trials Holdings Inc.","duties_or_roles":"Medical monitoring, Site Management, Site Activation including Negotiation of site clinical trial agreements, Trial Master File, Clinical Assessment Technologies, Risk Based Quality Management (RBQM), Drug Safety, Grant and Vendor Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Central Institutional Review Board (IRB)","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- NBI-74788
- Active Substance
- CRINECERFONT
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- prodAuthStatus=1
- Orphan Designation
- Yes
- Starting Dose
- 100 mg twice daily (bid)
- Dose Levels
- 100 mg twice daily
- Frequency
- Twice daily (bid)
- Investigational Product Name
- Crinecerfont placebo for oral capsules
- Modality
- Other
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