Evaluate the Efficacy and Safety of DWJ108J

Central Precocious Puberty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06025409
• Other study ID #: DW_DWJ108J301
• Status: Recruiting
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: Yeonseo Choi, MD. PhD
• Phone: 82-2-550-8800
• Email: yeonseo[@]daewoong.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 79
• Est. completion date: August 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• Leuprolide Acetate 11.25 MG/ML
Subcutaneous injection

Locations

Country	Name	City	State
Korea, Republic of	Ajou University medical center	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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