Evaluate the Efficacy and Safety of DWJ108J

Daewoong Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Central Precocious Puberty

Treatments: Drug: Leuprolide Acetate 11.25 MG/ML

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025409

DW_DWJ108J301

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of DWJ108J (Leuprorelin acetate 11.25 mg) in patients with central precocious puberty.

Full description

The drug in this study is called leuprorelin. It is administered as a 3 month subcutaneous depot injection. Leuprorelin is used to treat children who have Central Precocious Puberty. This study will look at whether leuprorelin can stop early Central Precocious Puberty.

Enrollment: 79 estimated patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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79 participants in 1 patient group

Experimental: Leuprorelin

Experimental group

Description:

Participants with body weight greater than or equal to (≥) 20 kilogram (kg) will receive the recommended dose of leuprorelin 11.25 milligram (mg), injection, subcutaneously, once every 3 months for 6 months. Participants with body weight less than (\<) 20 kg will receive leuprorelin 5.625 mg, injection, subcutaneously, once every 3 months for 6 months.

Treatment:

Drug: Leuprolide Acetate 11.25 MG/ML