Evaluating DWJ108J for treating early puberty in children

A Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWJ108J in Patients With Central Precocious Puberty : A Single-arm, Open-label, Multi-center, Prospective Study

This study tests if a new injection can help children with early puberty by slowing down their hormone changes.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 79 (estimated)
• Ages: 4 Years to 10 Years
• Sex: All
• Sponsor: Daewoong Pharmaceutical Co. LTD. (industry)
• Locations: 1 site (Gyeonggi-do)
• Trial ID: NCT06025409 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of DWJ108J, a formulation of leuprorelin acetate, administered as a subcutaneous depot injection every three months. It targets children diagnosed with central precocious puberty, aiming to determine if this treatment can effectively halt the progression of early puberty. The study will assess hormonal responses and monitor any potential side effects associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates are boys under 10 and girls under 9 who have been diagnosed with central precocious puberty and exhibit specific hormonal responses.

Not a fit: Patients with conditions related to pseudo precocious puberty or other hormonal dysfunctions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could help manage and potentially reverse the effects of central precocious puberty in affected children.

How similar studies have performed: Previous studies using leuprorelin for similar conditions have shown promising results, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
2. Diagnosis of central precocious puberty
3. For boys, those under 10 years old and for girls, those under 9 years old, based on Visit 2 (Enrollment), with Tanner Stage 2 or above
4. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
5. In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent

Exclusion Criteria:

1. Following conditions at Visit 1(Screening) :

   Conditions related to pseudo precocious puberty, Incomplete precocious puberty, Dysfunction of pituitary, adrenal, thyroid, or reproductive glands, Growth disorders or bone diseases that could affect bone growth, Brain tumor, Pituitary adenoma
2. requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
3. Prior treatment with GnRH analogues
4. Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
5. Prior or current therapy with growth hormone
6. has taken the following medications within 8 weeks of Visit 1 (Screening): Sex hormone medications, Sex hormone antagonists, Steroids (local application is allowed; oral formulations are not allowed if taken within 3 days continuously, and use within 2 weeks of screening is prohibited), Herbal medicine
7. Meets the following criteria based on screening test results:

   AST, ALT levels exceed twice the upper limit of normal, Creatinine levels exceed 1.5 times the upper limit of normal, Bone age is above 11.5 years
8. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study

Where this trial is running

Gyeonggi-do

• Ajou University medical center — Gyeonggi-do, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Jin Soong Hwang, MD. PhD — Ajou University School of Medicine
• Study coordinator: Yeonseo Choi, MD. PhD

Conditions: Central Precocious Puberty