ClinicalTrials.gg
RecruitingNCT07536269Updated Sep 16, 2026

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Crinecerfont in Participants With Classic Congenital Adrenal Hyperplasia (CAH) Who Are Less Than 4 Years Old

A Phase 2 interventional study of Crinecerfont in Congenital Adrenal Hyperplasia, sponsored by Neurocrine Switzerland GmbH. Recruiting at 11 sites in United States. Open to participants aged 3 Months to 47 Months. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Neurocrine Switzerland GmbH (part of Neurocrine Biosciences) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
3 Months to 47 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences — 2 open to participants now, 5 under way, 2 of them phase 3. Adrenal Hyperplasia, Congenital · Neurocrine Biosciences.

Planned enrollment
9th of 16
20 · median 24
Started
2026
with 1 other
Phase 2
6 of 16
2 open now
Registered
15th of 16
by date

Among the 16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences, this one is the 9th largest by planned enrollment, is one of 2 that started in 2026, is one of 6 in phase 2, and was the 15th registered.

Adrenal Hyperplasia, Congenital

101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.

Browse Adrenal Hyperplasia, Congenital studies →

Open to participants now

2 of the 16 studies in Adrenal Hyperplasia, Congenital by Neurocrine Biosciences are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Who these studies take

Of the 20 Adrenal Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; none take healthy volunteers.

This study: 3 Months to 47 Months · all sexes · no healthy volunteers.

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02

Study summary

The main objective of this study is to assess the safety and tolerability of crinecerfont in pediatric participants 3 months to \<4 years of age with CAH.

03

Conditions studied

  • Congenital Adrenal Hyperplasia

Keywords

  • Congenital Adrenal Hyperplasia
  • CAH
  • Crinecerfont
  • Pediatric
04

Who can participate

Ages eligible
3 Months to 47 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Have a medically confirmed diagnosis of classic CAH (salt wasting or simple virilizing) due to 21-hydroxylase deficiency (21-OHD)
  • Have received at least 3 months of hydrocortisone treatment before Day 1, with a stable dose for at least 4 weeks before screening.
  • Have a body weight of at least 4.5 kilograms (kg) at screening.
  • Have a newborn screen that is otherwise normal except for elevated 17-OHP or any other abnormality on newborn screen that was cleared upon evaluation by a pediatric specialist.

Key Exclusion Criteria:

  • Have a known or suspected diagnosis of any of the other forms of classic CAH.
  • Have any condition besides CAH that requires chronic daily therapy with orally administered .
  • Have any other medical condition or chronic disease.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Crinecerfont

    Participants with CAH will receive crinecerfont.

    Drug: Crinecerfont

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAE)

    Time frame: Day 1 up to 28 weeks

07

Study locations

11 of 11 sites recruiting
  • Neurocrine Clinical Site
    San Francisco, California 94143, United States
    Recruiting
  • Neurocrine Clinical Site
    Aurora, Colorado 80045, United States
    Recruiting
  • Neurocrine Clinical Site
    Hartford, Connecticut 06106, United States
    Recruiting
  • Neurocrine Clinical Site
    Atlanta, Georgia 30329, United States
    Recruiting
  • Neurocrine Clinical Site
    Chicago, Illinois 60618, United States
    Recruiting
  • Neurocrine Clinical Site
    Indianapolis, Indiana 46202, United States
    Recruiting
  • Neurocrine Clinical Site
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • Neurocrine Clinical Site
    Minneapolis, Minnesota 55454, United States
    Recruiting
  • Neurocrine Clinical Site
    Philadelphia, Pennsylvania 19104, United States
    Recruiting
  • Neurocrine Clinical Site
    Dallas, Texas 75235, United States
    Recruiting
  • Neurocrine Clinical Site
    Seattle, Washington 98101, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2026
First posted
Apr 17, 2026
StartActual
Jul 1, 2026
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07536269
Responsible party
Sponsor
First posted
Apr 17, 2026
Start date
Jul 1, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 16, 2026

Study contacts

Neurocrine Medical Information Call Center
Contact
medinfo@neurocrine.com
1-877-641-3461
Clinical Development Lead
study director · Neurocrine Biosciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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