RECRUITING

A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 1b/2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\])

Official Title

A Phase 1b/2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)

Quick Facts

Study Start:2023-10-12
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05804669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult male or female, aged 18 years or more
  2. 2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
  3. 3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
  4. 4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, cabergoline or metyrapone) may participate after a 14-day washout period, if they meet other study inclusion criteria
  1. 1. Women who are pregnant or lactating
  2. 2. History of bilateral adrenalectomy
  3. 3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
  4. 4. Presence of any known malignancy
  5. 5. Use of mitotane
  6. 6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

Contacts and Locations

Study Contact

Crinetics Clinical Trials
CONTACT
833-827-9741
clinicaltrials@crinetics.com

Study Locations (Sites)

National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: Crinetics Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12
Study Completion Date2026-10

Study Record Updates

Study Start Date2023-10-12
Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

  • Cushing Syndrome
  • Cushing Disease
  • Ectopic ACTH Syndrome