Congenital Adrenal HyperplasiaPhase 3NCT05299554
Long-term Safety Study of Chronocort in the Treatment of Participants With Congenital Adrenal Hyperplasia
A Phase 3 study testing Chronocort in people with Congenital Adrenal Hyperplasia, run by Immedica Pharma AB at 21 sites in 3 countries.
Trial summary
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Chronocort
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 1 Apr 2022to 15 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with Congenital Adrenal Hyperplasia (CAH) who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
- Participants who are capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the study's informed consent form (ICF) and in the protocol.
Who cannot join
- Participants with clinical or biochemical evidence of hepatic or renal disease e.g., creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- Participants with a history of bilateral adrenalectomy.
- Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
- Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids.
- Participants on regular daily inhaled, topical, nasal, or oral steroids for any indication other than CAH.
Show all 12Show fewer
- Participants anticipating regular prophylactic use of additional steroids e.g., for strenuous exercise.
- Participation in another clinical study of an investigational or licensed drug or device within 3 months prior to inclusion in this study, except for another clinical study with the current formulation of Chronocort.
- Females who are pregnant or lactating.
- Participants, who in the opinion of the Investigator, will be unable to comply with the requirements of the protocol.
- Participants who routinely work night shifts and so do not sleep during the usual night-time hours.
- Participants with a body weight of 50 kg or less (Note: this exclusion criterion is only applicable for French sites).
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
United States11 sites
Neurocrine Investigational Site in Michigan
Ann Arbor, Michigan, 48114
National Institutes of Health Center
Bethesda, Maryland, 20892-1932
Neurocrine Investigational Site in Texas
Dallas, Texas, 75235
Neurocrine Investigational Site in Iowa
Iowa City, Iowa, 52242
Neurocrine Investigational Site in Florida
Jacksonville, Florida, 32207
Neurocrine Investigational Site in Nevada
Las Vegas, Nevada, 89148
Neurocrine Investigational Site in California
Los Angeles, California, 90027
Neurocrine Investigational Site in Wisconsin
Milwaukee, Wisconsin, 53226
Neurocrine Investigational Site in California
Orange, California, 92868
Neurocrine Investigational Site in Minnesota
Rochester, Minnesota, 55901
Neurocrine Investigational Site in Washington
Seattle, Washington, 98105
France6 sites
Neurocrine Investigational Site in Caen
Caen, 14033
Neurocrine investigational Site in Lyon
Lyon, 69677
Neurocrine Investigational Site in Paris
Paris, 75651
Neurocrine Investigational Site in Pessac
Pessac, 33604
Neurocrine Investigational Site in Toulouse (Children's hospital)
Toulouse, 31059
Neurocrine Investigational Site in Toulouse
Toulouse, 31059
Japan4 sites
Neurocrine Investigational Site in Yushima
Bunkyō-Ku, Tokyo, 113-8519
Neurocrine Investigational Site in Okura
Setagaya-Ku, Tokyo, 157-8535
Neurocrine Investigational Site in Toyama
Shinjuku-Ku, Tokyo, 162-8655
Neurocrine Investigational Site in Asahi-ku
Yokohama, Kanagawa, 241-0811
About this study
Official title: A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).
Read the detailed description
Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in this extension study will then undergo the final visit of the feeder study, with the assessments conducted at the final visit also providing the baseline data for this DIUR-015 extension study where relevant (note participants who are withdrawn from treatment due to titration issues in study DIUR-014 are eligible to enter at the discretion of the Investigator, as long as all DIUR-014 safety assessments and the end of study visit are completed). Once all the baseline assessments are completed, participants will be given sufficient Chronocort to use until the next visit (the study pharmacies will be supplied with Chronocort for dispensing to participants according to the Investigators' instructions).
Outcome measures in this study will be assessed versus either the 'initial study baseline' (measurements taken at the start of participation in an interventional Chronocort study, regardless of the treatment assignment in this feeder study) or the protocol-defined 'pre-Chronocort baseline' (measurements taken prior to the first dose of continuous Chronocort) or the 'DIUR-015 baseline' (measurements taken at the start of participation in DIUR-015 study).
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Chronocort
- Keywords
- Extension study
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChronocortDrug
Also called Hydrocortisone modified-release hard capsule
Hydrocortisone modified-release capsule 5 mg and 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Chronocort (hydrocortisone modified-release capsule) | Experimental | Chronocort (hydrocortisone modified-release capsules) supplied as 5 mg and 10 mg per capsule for oral administration. Receives: Drug: Chronocort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.
Over-replacement normally presents with chronic effects such as weight gain, increased appetite, sleeping difficulties, increased acne and Cushingoid syndrome.
Measured: Up to 32 months
Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.
Under-replacement normally presents with acute effects such as sudden weight loss, lack of appetite, nausea, vomiting, headache, blurred vision, fatigue, weakness, dizziness, light-headedness and syncope.
Measured: Up to 32 months.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of use of additional glucocorticoid treatment throughout the study.
Use of Immediate Release Hydrocortisone (IRHC) from the emergency packs for stress dosing or use of any additional glucocorticoid treatment.
Measured: Up to 32 months
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.
Occurrence of adrenal crises throughout the study.
Measured: Up to 32 months
To measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
The incidence, nature, severity, relatedness, duration, outcome, seriousness, and expectedness of treatment-emergent adverse events (TEAEs) throughout the study.
Measured: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of hematology safety laboratory assessments [Safety and Tolerability].
Lab parameters will be summarized and compared throughout the study as follows:
Platelet count, Red blood cell count (RBC), Haemoglobin, Haematocrit, RBC Indices: Mean corpuscular volume (MCV), Mean cell haemoglobin (MCH). Mean cell haemoglobin concentration (MCHC), Red cell distribution width (RDW).
White blood cell (WBC) count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils.
Measured: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability].
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability].
Blood urea nitrogen (BUN), Creatinine, Chloride, Total magnesium, Potassium, Sodium, Calcium, Total carbon dioxide (CO2), Inorganic phosphorus, AST/serum glutamic-oxaloacetic transaminase (SGOT), ALT/serum glutamic-pyruvic transaminase (SGPT), Alkaline phosphatase, Albumin, Total and direct bilirubin, Total protein, Lactate dehydrogenase (LDH), Total creatine kinase (CK), Uric acid.
Measured: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of vital signs assessments.
Blood pressure measurements throughout the study will be summarised and compared.
Measured: Up to 32 months
Secondary outcomes (8)
To assess the impact of treatment on dose of steroid required - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in total daily steroid dose in hydrocortisone equivalent dose at each visit.
Measured: Up to 32 months
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from pre-Chronocort baseline
Change in 17-OHP levels from pre Chronocort baseline at each visit.
Measured: Up to 32 months
To assess the impact of treatment on Androstenedione (A4) levels - Change from pre-Chronocort baseline
Change in A4 levels from pre-Chronocort baseline at each visit.
Measured: Up to 32 months
To assess the impact of treatment on menstrual regularity (recorded in a participant diary) as a marker of fertility - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in menstrual regularity as recorded in a participant diary. With menstrual regularity defined as a cycle (menstrual bleeding) occurring every 21 to 35 days (only in pre-menopausal females without hysterectomy and not using hormonal contraceptives).
Measured: Up to 32 months
To assess the impact of treatment on luteinising hormone (LH) levels in men as a marker of fertility - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline in luteinising hormone (LH) levels throughout the study.
Measured: Up to 32 months
To assess the impact of treatment on testosterone by sex - Change from pre-Chronocort baseline
Change in testosterone levels from pre-Chronocort baseline through the study, summarized by gender.
Measured: Up to 32 months
To assess the impact of treatment on waist circumference - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline to each visit in waist circumference.
Measured: Up to 32 months
To assess the impact of treatment on body weight - Change from pre-Chronocort baseline
Change from pre-Chronocort baseline to each visit in body weight.
Measured: Up to 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Apr 2022
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm extension study
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immedica Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- D Merke, Principal investigator, National Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299554
- Sponsor's protocol ID
- DIUR-015
- Other IDs
- 2021-004467-26
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2022
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label Extension Study to Evaluate the Long-term Safety and Tolerability of Chronocort in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
- ClinicalTrials.gov ID
- NCT05299554
- Acronym / sponsor ID
- DIUR-015
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Extension study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Immedica Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase III study is an open-label extension study to be conducted at approximately 21 investigational sites across 3 countries. The study will evaluate the long-term safety and tolerability of Chronocort in participants aged 16 years and over when used as treatment for Congenital Adrenal Hyperplasia (CAH).
Detailed description
Participants in eligible countries completing one of the specified previous Chronocort studies (DIUR-006 and DIUR 014) can either continue Chronocort treatment (if the participant received Chronocort in the feeder study) or switch to Chronocort treatment (if the participant received standard glucocorticoid therapy in the feeder study) in this open-label extension study. All participants choosing to enter this extension study will have the study procedures fully explained and informed consent obtained, prior to, or at the last visit of the feeder study. Participants who agree to take part in this extension study will then undergo the final visit of the feeder study, with the assessments conducted at the final visit also providing the baseline data for this DIUR-015 extension study where relevant (note participants who are withdrawn from treatment due to titration issues in study DIUR-014 are eligible to enter at the discretion of the Investigator, as long as all DIUR-014 safety assessments and the end of study visit are completed). Once all the baseline assessments are completed, participants will be given sufficient Chronocort to use until the next visit (the study pharmacies will be supplied with Chronocort for dispensing to participants according to the Investigators' instructions).
Outcome measures in this study will be assessed versus either the 'initial study baseline' (measurements taken at the start of participation in an interventional Chronocort study, regardless of the treatment assignment in this feeder study) or the protocol-defined 'pre-Chronocort baseline' (measurements taken prior to the first dose of continuous Chronocort) or the 'DIUR-015 baseline' (measurements taken at the start of participation in DIUR-015 study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm extension study
| Arm | Type | Receives |
|---|---|---|
| Chronocort (hydrocortisone modified-release capsule) | Experimental | Drug: ChronocortChronocort (hydrocortisone modified-release capsules) supplied as 5 mg and 10 mg per capsule for oral administration. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with Congenital Adrenal Hyperplasia (CAH) who have successfully completed Chronocort study DIUR-006 (sites in France and US only) or study DIUR-014.
- Participants who are capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the study's informed consent form (ICF) and in the protocol.
Key exclusion criteria (12 listed)
- Participants with clinical or biochemical evidence of hepatic or renal disease e.g., creatinine >2 times the upper limit of normal (ULN) or elevated liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 times the ULN).
- Participants with a history of malignancy (other than basal cell carcinoma successfully treated >26 weeks prior to entry into the study).
- Participants with a history of bilateral adrenalectomy.
- Participants with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the study.
- Participants with a co-morbid condition requiring daily administration of a medication or consumption of any material that interferes with the metabolism of glucocorticoids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChronocortAlso: Hydrocortisone modified-release hard capsuleHydrocortisone modified-release capsule 5 mg and 10 mg | Drug | Chronocort (hydrocortisone modified-release capsule) |
Primary outcome
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study.
Time frame: Up to 32 months
Over-replacement normally presents with chronic effects such as weight gain, increased appetite, sleeping difficulties, increased acne and Cushingoid syndrome.
Signs and symptoms of under-treatment [Safety and Tolerability] throughout the study.
Time frame: Up to 32 months.
Under-replacement normally presents with acute effects such as sudden weight loss, lack of appetite, nausea, vomiting, headache, blurred vision, fatigue, weakness, dizziness, light-headedness and syncope.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of use of additional glucocorticoid treatment throughout the study.
Time frame: Up to 32 months
Use of Immediate Release Hydrocortisone (IRHC) from the emergency packs for stress dosing or use of any additional glucocorticoid treatment.
To measure signs or symptoms of under treatment [Safety and Tolerability] in terms of incidence of adrenal crises throughout the study.
Time frame: Up to 32 months
Occurrence of adrenal crises throughout the study.
To measure the incidence of Treatment-Emergent Adverse Events [Safety and Tolerability].
Time frame: Up to 32 months
The incidence, nature, severity, relatedness, duration, outcome, seriousness, and expectedness of treatment-emergent adverse events (TEAEs) throughout the study.
To measure the change from pre-Chronocort baseline in terms of hematology safety laboratory assessments [Safety and Tolerability].
Time frame: Up to 32 months
Lab parameters will be summarized and compared throughout the study as follows: Platelet count, Red blood cell count (RBC), Haemoglobin, Haematocrit, RBC Indices: Mean corpuscular volume (MCV), Mean cell haemoglobin (MCH). Mean cell haemoglobin concentration (MCHC), Red cell distribution width (RDW). White blood cell (WBC) count with differential (absolute and %): Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils.
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability].
Time frame: Up to 32 months
To measure the change from pre-Chronocort baseline in terms of clinical chemistry safety laboratory assessments [Safety and Tolerability]. Blood urea nitrogen (BUN), Creatinine, Chloride, Total magnesium, Potassium, Sodium, Calcium, Total carbon dioxide (CO2), Inorganic phosphorus, AST/serum glutamic-oxaloacetic transaminase (SGOT), ALT/serum glutamic-pyruvic transaminase (SGPT), Alkaline phosphatase, Albumin, Total and direct bilirubin, Total protein, Lactate dehydrogenase (LDH), Total creatine kinase (CK), Uric acid.
To measure the change from pre-Chronocort baseline in terms of vital signs assessments.
Time frame: Up to 32 months
Blood pressure measurements throughout the study will be summarised and compared.
8 secondary outcomes
To assess the impact of treatment on dose of steroid required - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on 17-Hydroxyprogesterone (17-OHP) levels - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on Androstenedione (A4) levels - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on menstrual regularity (recorded in a participant diary) as a marker of fertility - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on luteinising hormone (LH) levels in men as a marker of fertility - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on testosterone by sex - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on waist circumference - Change from pre-Chronocort baseline
Time frame: Up to 32 months
To assess the impact of treatment on body weight - Change from pre-Chronocort baseline
Time frame: Up to 32 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
D Merke principal investigator
National Instiututes of Health Clinical Centre, Bethesda, Maryland, United States, 20892-1932
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chronocort in people with Congenital Adrenal Hyperplasia, run by Immedica Pharma AB at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, France, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signs and symptoms of over-treatment [Safety and Tolerability] throughout the study. (time frame: Up to 32 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.