Clinical Trials Logo
  1. Home
  2. Congenital Adrenal Hyperplasia
  3. NCT04490915
  4. Details
NCT04490915 Clinical Trial

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia Clinical Trial

— CAHtalyst  

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04490915
Other study ID # NBI-74788-CAH3003
Secondary ID 2019-004873-17
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 16, 2020
Est. completion date August 2027

Study information
Verified date May 2024
Source Neurocrine Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 6-month randomized, double-blind, placebo-controlled period, followed by 1 year of open-label treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per subject for the OLE (estimated to be approximately 3 years).

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Crinecerfont
CRF1-receptor antagonist
• Placebo
Non-active dosage form
See more »

Sponsors (1)
Lead Sponsor Collaborator
Neurocrine Biosciences

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Serbia,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline in glucocorticoid daily dose at Week 24 Baseline and Week 24
Secondary Change from baseline in serum androstenedione at Week 4 Baseline and Week 4
Secondary Achievement of a reduction in glucocorticoid daily dose to physiologic levels at Week 24 Baseline and Week 24
Secondary Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR) index at Week 24 Baseline and Week 24
Secondary Change from baseline in body weight at Week 24 Baseline and Week 24
Secondary Change from baseline in fat mass at Week 24 Baseline and Week 24
Secondary Change from baseline in blood pressure at Week 24 Baseline and Week 24
Secondary Change from baseline in glucose tolerance at Week 24 Baseline and Week 24
Secondary Change from baseline in waist circumference at Week 24 Baseline and Week 24
Secondary Change from baseline in menstrual regularity at Week 24 Baseline and Week 24
Secondary Change from baseline in testicular adrenal rest tumor size at Week 24 Baseline and Week 24
See also
  Status Clinical Trial Phase
Completed NCT03687242 - Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia Phase 2
Active, not recruiting NCT04544410 - A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH Phase 2
Not yet recruiting NCT04087148 - Linear Growth of Children With Congenital Adrenal Hyperplasia
Completed NCT03162159 - Adult Height Prediction in Congenital Adrenal Hyperplasia
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Enrolling by invitation NCT05162950 - Effects and Importance of Epinephrine/Adrenalin Deficiency in CAH
Withdrawn NCT03532022 - Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy Phase 3
Recruiting NCT02795871 - Prenatal Dex Study N/A
Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Recruiting NCT04903587 - Gonadal Changes In Congenital Adrenal Hyperplasia Patients
Not yet recruiting NCT04536662 - Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency Phase 4
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Completed NCT01807364 - Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia N/A
Completed NCT02804178 - A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia Phase 2
Completed NCT03019614 - An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Phase 1
Not yet recruiting NCT04293133 - Final Height in Patients With CAH
Recruiting NCT03897504 - Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty N/A
Recruiting NCT05663320 - A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia N/A
Active, not recruiting NCT04806451 - Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) Phase 3
Completed NCT01875640 - Decision Support for Parents Receiving Information About Child's Rare Disease

External Links