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New hope for CAH: drug may slash steroid use

NCT ID NCT04490915

Disease control Sponsor: Neurocrine Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called crinecerfont in adults with classic congenital adrenal hyperplasia (CAH), a genetic condition that requires lifelong steroid treatment. The goal is to see if crinecerfont can safely reduce the daily steroid dose needed while keeping hormone levels under control. About 182 participants will receive either crinecerfont or a placebo for 24 weeks, followed by open-label treatment for up to 3 years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

182 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit. 2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency. 3. Be on a stable steroid regimen. 4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study. Exclusion Criteria: 1. Have a diagnosis of any of the other known forms of classic CAH. 2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy. 3. Have a clinically significant unstable medical condition or chronic disease other than CAH. 4. Have a history of cancer unless considered cured. 5. Are pregnant. 6. Have a known history of clinically significant arrhythmia or abnormalities on ECG. 7. Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists. 8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study. 9. Have current substance dependence, or current substance (drug) or alcohol abuse. 10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.

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Conditions

The condition(s) this trial relates to.

classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency congenital adrenal hyperplasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congenital adrenal hyperplasia

Contacts and locations

Locations

  • Neurocrine Clinical Site

    Los Angeles, California, 90027, United States

  • Neurocrine Clinical Site

    San Diego, California, 92123, United States

  • Neurocrine Clinical Site

    San Francisco, California, 94143, United States

  • Neurocrine Clinical Site

    Aurora, Colorado, 80045, United States

  • Neurocrine Clinical Site

    Atlanta, Georgia, 30329, United States

  • Neurocrine Clinical Site

    Indianapolis, Indiana, 46202, United States

  • Neurocrine Clinical Site

    Bethesda, Maryland, 20982, United States

  • Neurocrine Clinical Site

    Boston, Massachusetts, 02115, United States

  • Neurocrine Clinical Site

    Ann Arbor, Michigan, 48109, United States

  • Neurocrine Clinical Site

    Minneapolis, Minnesota, 55454, United States

  • Neurocrine Clinical Site

    Rochester, Minnesota, 55905, United States

  • Neurocrine Clinical Site

    St Louis, Missouri, 63110, United States

  • Neurocrine Clinical Site

    Great Neck, New York, 11021, United States

  • Neurocrine Clinical Site

    New York, New York, 10029, United States

  • Neurocrine Clinical Site

    Winston-Salem, North Carolina, 27157, United States

  • Neurocrine Clinical Site

    Tulsa, Oklahoma, 74135, United States

  • Neurocrine Clinical Site

    Philadelphia, Pennsylvania, 19104, United States

  • Neurocrine Clinical Site

    Pittsburgh, Pennsylvania, 15224, United States

  • Neurocrine Clinical Site

    Dallas, Texas, 75390, United States

  • Neurocrine Clinical Site

    Seattle, Washington, 98105, United States

  • Neurocrine Clinical Site

    Graz, 8036, Austria

  • Neurocrine Clinical Site

    Vienna, 1090, Austria

  • Neurocrine Clinical Site

    Brussels, 1070, Belgium

  • Neurocrine Clinical Site

    Leuven, 3000, Belgium

  • Neurocrine Clinical Site

    Sofia, 1431, Bulgaria

  • Neurocrine Clinical Site

    Sofia, 1606, Bulgaria

  • Neurocrine Clinical Site

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Neurocrine Clinical Site

    Hradec Králové, 50005, Czechia

  • Neurocrine Clinical Site

    Angers, 49933, France

  • Neurocrine Clinical Site

    Grenoble, 38700, France

  • Neurocrine Clinical Site

    Le Kremlin-Bicêtre, 94270, France

  • Neurocrine Clinical Site

    Nantes, 44093, France

  • Neurocrine Clinical Site

    Paris, 75651, France

  • Neurocrine Clinical Site

    Paris, 75679, France

  • Neurocrine Clinical Site

    Dresden, 01307, Germany

  • Neurocrine Clinical Site

    Essen, 45147, Germany

  • Neurocrine Clinical Site

    Frankfurt, 60590, Germany

  • Neurocrine Clinical Site

    Leipzig, 04103, Germany

  • Neurocrine Clinical Site

    Munich, 80336, Germany

  • Neurocrine Clinical Site

    Athens, 106 76, Greece

  • Neurocrine Clinical Site

    Athens, 115 27, Greece

  • Neurocrine Clinical Site

    Athens, 11527, Greece

  • Neurocrine Clinical Site

    Thessaloniki, 54642, Greece

  • Neurocrine Clinical Site

    Afula, 1834111, Israel

  • Neurocrine Clinical Site

    Beersheba, 8410101, Israel

  • Neurocrine Clinical Site

    Petah Tikva, 4941480, Israel

  • Neurocrine Clinical Site

    Tel Aviv, 64239, Israel

  • Neurocrine Clinical Site

    Ancona, 60126, Italy

  • Neurocrine Clinical Site

    Bologna, 40138, Italy

  • Neurocrine Clinical Site

    Florence, 50139, Italy

  • Neurocrine Clinical Site

    Messina, 98125, Italy

  • Neurocrine Clinical Site

    Milan, 20132, Italy

  • Neurocrine Clinical Site

    Milan, 20149, Italy

  • Neurocrine Clinical Site

    Naples, 80131, Italy

  • Neurocrine Clinical Site

    Padova, 35128, Italy

  • Neurocrine Clinical Site

    Roma, 00161, Italy

  • Neurocrine Clinical Site

    Leiden, 2333, Netherlands

  • Neurocrine Clinical Site

    Krakow, 31-011, Poland

  • Neurocrine Clinical Site

    Poznan, 60-355, Poland

  • Neurocrine Clinical Site

    Warsaw, 01-809, Poland

  • Neurocrine Clinical Site

    Porto, 4200-319, Portugal

  • Neurocrine Clinical Site

    Belgrade, 11000, Serbia

  • Neurocrine Clinical Site

    Madrid, 28034, Spain

  • Neurocrine Clinical Site

    Seville, 41013, Spain

  • Neurocrine Clinical Site

    Gothenburg, 41345, Sweden

  • Neurocrine Clinical Site

    Stockholm, 17176, Sweden

  • Neurocrine Clinical Site

    Cardiff, CF14 4HH, United Kingdom

  • Neurocrine Clinical Site

    London, WC1B 5EH, United Kingdom

  • Neurocrine Clinical Site

    Manchester, M20 4BX, United Kingdom

  • Neurocrine Clinical Site

    Salford, M6 8HD, United Kingdom

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