Evaluate the Efficacy and Safety of DWJ108J

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

Study Overview

• Status: Recruiting
• Conditions: Central Precocious Puberty
• Intervention / Treatment: Drug: Leuprolide Acetate 11.25 MG/ML

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 79
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yeonseo Choi, MD. PhD; Phone Number: 82-2-550-8800; Email: yeonseo@daewoong.co.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • Recruiting
    • Ajou University Medical Center
    • Contact: Jin Soon Hwang; Phone Number: 82-1688-6114; Email: yeonseo@daewoong.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Leuprorelin; 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.	Drug: Leuprolide Acetate 11.25 MG/ML; Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.	Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.	Luteinizing Hormone (LH) suppression is defined as peak-stimulated LH ≤ 3 IU/L.	3 months
Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.	Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.	Baseline, 3 and 6 months
Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration	Average LH peak and FSH peak through GnRH stimulation test at 3 and 6 months after administration, and the changes in each time point compared to before administration	3 and 6 months
Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.	Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.	Baseline, 3 and 6 months
Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.	Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.	6 months
Average Tanner Stage at 6 months after administration, and the changes compared to before administration.	Average Tanner Stage at 6 months after administration, and the changes compared to before administration.	6 months
Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.	Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.	6 months

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Jin Soong Hwang, MD. PhD, Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Estimated): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Reproductive Control Agents; Fertility Agents, Female; Fertility Agents; Leuprolide
• Other Study ID Numbers: DW_DWJ108J301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No