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Tests treatment safety and results for Congenital Adrenal Hyperplasia
Official title An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia
ClinicalTrials.gov ID: NCT06712823
What this study is testing
What is atumelnant (CRN04894)?
atumelnant (CRN04894) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for congenital adrenal hyperplasia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 to 74
You may be able to join if
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had...
- Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent...
- Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement...
- Female participants who engage in heterosexual intercourse must:
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to...
- Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
- Participants have any mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or...
- Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal...
- Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this...
See the full eligibility criteria
- Participants are eligible to be included in the study only if all the following criteria apply:
- Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would...
- Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent study and the commencement of the OLE study.
- Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement of the OLE study.
- Female participants who engage in heterosexual intercourse must:
- Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR
- Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test...
- Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local...
- Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile [ie...
- Participants are willing and able to give signed informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF).
- Participants are willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment.
- Participants are excluded from the study if any of the following criteria apply:
- Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study.
- Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.
- Participants have any 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.
- Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator.
- 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...
- Participant is an employee or immediate family member of an employee of Crinetics.
- Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an...
- Participants who have had an active malignant disease within the last 5 years prior to Screening excluding dermal squamous or basal cell carcinoma of the skin with complete local excision or resected cervical carcinoma...
- Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. Specific for Participants Not Currently Receiving Atumelnant
- Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe...
- Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
- Participants with a history of major surgery/surgical therapy for any cause within 4 weeks prior to Screening.
- Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol/mL).
- Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator.
- Participant has an average (of 3 electrocardiograms [ECGs]) Fridericia's corrected QT (QTcF) interval \>450 milliseconds (msec) (men) or \>470 msec (women), time interval between P and R waves (PR interval) \>220 msec...
The study team makes the final eligibility decision.
Where it's taking place
- Minneapolis, Minnesota, United States
- Morehead City, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Córdoba, Córdoba Province, Argentina
- Curitiba, Paraná, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Botucatu, São Paulo, Brazil
- Rio de Janeiro, Brazil
- São Paulo, Brazil
- Munich, Bavaria, Germany
- Roma, Italy
- Birmingham, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years to 74 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minneapolis, Minnesota, United States; Morehead City, North Carolina, United States; Philadelphia, Pennsylvania, United States; Córdoba, Córdoba Province, Argentina; Curitiba, Paraná, Brazil; Porto Alegre, Rio Grande do Sul, Brazil and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.