Menu
Recruiting NCT05804669

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

Phase I / Phase II Interventional Cushing Syndrome Cushing Disease Ectopic ACTH Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: atumelnant.
Who it may be relevant to
Registry conditions: Cushing Syndrome, Cushing Disease, Ectopic ACTH Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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 \[EAS\])

Detailed description

This is 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 atumelnant (also known as CRN04894) (an adrenocorticotropic hormone \[ACTH\] receptor antagonist) over a 10-day or 14-day treatment period in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \[EAS\]). Participants will receive oral atumelnant once daily for 10 days followed by monitoring during 4 'wash-out' days, or for 14 days.

Interventions

  • Drug atumelnant
    Atumelnant is an orally active investigational agent which antagonizes the action of ACTH at its receptor administered as oral tablets.

Primary outcome measures

  • Proportion of participants with treatment emergent adverse events (TEAEs) [Time frame: Up to Day 15]
  • Proportion of participants with adrenal insufficiency [Time frame: Up to Day 15]
  • Proportion of participants with safety findings determined by laboratory testing [Time frame: Up to Day 15]
  • Assessment of the maximum observed plasma concentration of CRN04894 [Time frame: Up to Day 15]
  • Assessment of the time to achieve maximum observed plasma concentration of CRN04894 [Time frame: Up to Day 15]
  • Assessment of the plasma area under the curve of CRN04894 [Time frame: Up to Day 15]
Secondary outcome measures (1)
  • Change from baseline in early morning serum cortisol [Time frame: Up to Day 15]

Eligibility criteria

Inclusion criteria

  • Adult male or female, aged 18 years or more
  • Evidence of chronic 'active' ACTH-dependent Cushing's syndrome
  • Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1
  • Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria

Exclusion criteria

  • Women who are pregnant or lactating
  • History of bilateral adrenalectomy
  • Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm
  • Presence of any known malignancy
  • Use of mitotane
  • Previous unsuccessful surgery for Cushing's syndrome within 6 weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • National Institutes of Health (NIH) - National Institute of Diabetes and Digestive and Kid — Bethesda

Identifiers

NCT: NCT05804669 · CRN04894-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗