Health TrialsbyHealthPanel

An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia

ConditionsCongenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16-74
SponsorCrinetics Pharmaceuticals Inc.

About this trial

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 benefit from continued dosing in this extension study.

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.

Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • atumelnant (CRN04894)

    Drug

    Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) receptor antagonist.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs), including treatment-emergent serious adverse events (SAEs), adverse events of special interest (AESI [adrenal insufficiency]) and any adverse events (AEs) leading to discontinuation

Time frame
Week 108
2

Incidence of glucocorticoid (GC) deficiency / adrenal insufficiency and adrenal crisis

Time frame
Week 108
3

Incidence of hospitalizations related to congenital adrenal hyperplasia (CAH)

Time frame
Week 108
4

Change from baseline in morning (before 11:00 AM) serum androstenedione (A4) over time

Time frame
Week 108

Secondary outcomes

1

Change from baseline in morning (before 11:00 AM) serum 17-hydroxyprogesterone (17-OHP) over time

Time frame
Week 108
2

Change from baseline in daily glucocorticoid (GC) dose (hydrocortisone [HC] mg equivalents body surface area [BSA] adjusted) over time

Time frame
Week 108

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crinetics Pharmaceuticals Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now