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ATUMELNANT

Clinical trials are investigating ATUMELNANT in people with congenital adrenal hyperplasia, including adults and pediatric participants. These studies are looking at safety, tolerability, and how well the treatment may control adrenal androgen levels while helping reduce glucocorticoid use. The trials are in Phase 2, Phase 3, and Phase 4.

Table of contents

Clinical trial overview

The available studies of ATUMELNANT are focused on congenital adrenal hyperplasia, including classic congenital adrenal hyperplasia.[1][2][3] These are interventional studies, which means participants receive a study treatment so researchers can measure its effects.[1][2][3]

All three listed trials are currently Authorised.[1][2][3] The studies are looking at safety, tolerability, and whether ATUMELNANT can help control adrenal hormone levels while lowering the need for glucocorticoid treatment.[1][2][3]

Who the trials include

The trial set includes both adult participants and pediatric participants.[2][3] The pediatric study is designed for children and adolescents with classic congenital adrenal hyperplasia, while the adult study is for adults with the same disease.[2][3]

The Phase 2 trial is broader in its condition wording and includes participants with congenital adrenal hyperplasia.[1] The trial records do not provide more detailed age or eligibility rules, so only the population named in each study can be stated here.[1][2][3]

Trial phases and study design

ATUMELNANT is being studied across Phase 2, Phase 3, and Phase 4 trials.[1][2][3] Phase 2 usually helps researchers learn more about safety and early effectiveness, Phase 3 is a larger confirmatory stage, and Phase 4 is a later study stage that can add more information after earlier testing.[1][2][3]

The Phase 2 study plans to enroll 150 participants, the Phase 4 pediatric study plans to enroll 156 participants, and the Phase 3 adult study plans to enroll 140 participants.[1][2][3] This range shows that the program includes both mid-size and larger studies.[1][2][3]

Main endpoints being measured

The studies mainly measure safety and efficacy, which means how well the treatment works.[1][2][3] Safety outcomes include treatment-emergent adverse events, serious adverse events, and adverse events that lead to stopping treatment.[1][2]

Some safety endpoints also look at glucocorticoid deficiency, adrenal insufficiency, adrenal crisis, and hospitalizations related to congenital adrenal hyperplasia.[1] These terms describe important medical problems that can happen when the body does not have enough adrenal hormone support or when the disease becomes severe.[1]

The main efficacy measure in the Phase 2 trial is the change from baseline in morning serum A4 over time.[1] In the pediatric Phase 4 study, one part looks at the change from baseline in morning A4 at Week 8, another part looks at the percent change in daily glucocorticoid dose at Week 28 while serum early morning A4 stays at or below the upper limit of normal, and another part again measures change in morning A4 over time.[2]

The adult Phase 3 study measures the proportion of participants with morning post-glucocorticoid A4 at or below the upper limit of normal who are on physiologic glucocorticoid replacement at Week 32.[3] In simple terms, this asks how many participants can keep hormone levels controlled while using a replacement dose of glucocorticoid that is intended to be close to normal body needs.[3]

Key trial details

The Phase 2 study is titled “A study to learn about the safety and effectiveness of CRN04894 on participants,” and it is listed under congenital adrenal hyperplasia.[1] Its brief summary says the main safety objective is to evaluate safety and tolerability, and the main efficacy objective is to evaluate change from baseline in serum androstenedione (A4).[1]

The pediatric Phase 4 study is titled “A Study in Pediatric Participants with Congenital Adrenal Hyperplasia,” and it focuses on classic congenital adrenal hyperplasia.[2] Its brief summary says the study wants to evaluate safety and tolerability in pediatric participants, and also whether ATUMELNANT can reduce daily glucocorticoid dose while keeping adrenal androgen levels normalized.[2]

The adult Phase 3 study is titled “A Study to Evaluate Atumelnant in Adults with Congenital Adrenal Hyperplasia,” and it also focuses on classic congenital adrenal hyperplasia.[3] Its brief summary says the study compares ATUMELNANT with placebo to see whether it can reduce daily glucocorticoid dosage while maintaining adrenal androgen control at the end of the 32-week treatment period.[3]

The intervention records show oral tablet forms for ATUMELNANT in the pediatric and adult studies, with tablet strengths listed in the source data.[2][3] The source data also names a 120 mg oral dose in the Phase 2 study.[1]

Summary of the listed trials

Trial ID Title Phase Condition Status Enrollment Main focus
2024-514846-35-00 A study to learn about the safety and effectiveness of CRN04894 on participants Phase 2 Congenital adrenal hyperplasia Authorised 150 Safety, tolerability, and change in morning serum A4
2024-519578-38-00 A Study in Pediatric Participants with Congenital Adrenal Hyperplasia Phase 4 Classic congenital adrenal hyperplasia Authorised 156 Safety, A4 change, and glucocorticoid dose reduction
2024-519579-24-00 A Study to Evaluate Atumelnant in Adults with Congenital Adrenal Hyperplasia Phase 3 Classic congenital adrenal hyperplasia Authorised 140 Placebo comparison and control of adrenal androgen levels
Trial ID Phase Condition studied Status Enrollment
2024-514846-35-00 Phase 2 Congenital adrenal hyperplasia Authorised 150
2024-519578-38-00 Phase 4 Classic congenital adrenal hyperplasia Authorised 156
2024-519579-24-00 Phase 3 Classic congenital adrenal hyperplasia Authorised 140

FAQ

  • What conditions are being studied in ATUMELNANT trials? The trials are studying classic congenital adrenal hyperplasia and congenital adrenal hyperplasia. These studies focus on people whose disease needs ongoing treatment and hormone control.
  • Who can take part in these trials? The trials include adults and pediatric participants. Each study has its own age group and entry rules, so not every participant type is in every trial.
  • What phases are the ATUMELNANT trials in? The listed trials are in Phase 2, Phase 3, and Phase 4. These phases help researchers learn more about safety, effectiveness, and how the treatment works in real-world use.
  • What are the trials trying to measure? The studies measure safety outcomes such as treatment-emergent adverse events and serious adverse events. They also measure changes in morning serum A4 and changes in daily glucocorticoid dose.
  • How many participants are planned for these studies? The planned enrollment ranges from 140 to 156 participants in the listed trials. This gives researchers enough people to study safety and treatment effects.

Ongoing Clinical Trials on ATUMELNANT

  • A Study of Atumelnant for Children with Congenital Adrenal Hyperplasia

    Recruiting

    4 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Poland

  • A Study Testing Atumelnant Compared to Placebo in Adults with Classic Congenital Adrenal Hyperplasia to Reduce Steroid Dose While Controlling Hormones

    Recruiting

    3 1
    Investigated drugs:
    Austria France Germany Italy The Netherlands Poland +1

  • Study on the Safety and Effectiveness of CRN04894 for Patients with Congenital Adrenal Hyperplasia

    Recruiting

    2 1 1
    Investigated drugs:
    Germany Italy

Glossary

  • Congenital adrenal hyperplasia (CAH): A group of inherited conditions that affect the adrenal glands. In these trials, the condition is the main disease being studied.
  • Classic congenital adrenal hyperplasia: A form of CAH that is specifically named in the trial records. It is the target condition for the adult and pediatric studies.
  • Pediatric participants: Children and adolescents who are taking part in a study.
  • Adults: Grown-up participants who are eligible for the adult trial.
  • Phase 2: An earlier study phase that looks at safety and early signs of effectiveness.
  • Phase 3: A larger study phase that compares a treatment with placebo or standard care and looks closely at how well it works.
  • Phase 4: A later study phase done after earlier testing, often to learn more about safety and effectiveness in a wider group.
  • Interventional study: A study where participants receive a treatment or intervention so researchers can measure its effects.
  • Treatment-emergent adverse events (TEAEs): Health problems that appear or get worse after a participant starts the study treatment.
  • Serious adverse events (SAEs): Severe health problems that are more serious than routine side effects and may need urgent care.
  • Glucocorticoid (GC): A type of medicine used in CAH. The trials measure whether the daily dose can be reduced while keeping hormone control.
  • Androstenedione (A4): A hormone measured in the studies. The trials track changes in morning serum A4 as a key result.

References

  1. https://clinicaltrials.gov/study/2024-514846-35-00
  2. https://clinicaltrials.gov/study/2024-519578-38-00
  3. https://clinicaltrials.gov/study/2024-519579-24-00