Clinical trial NCT06025409: Evaluate the Efficacy and Safety of DWJ108J
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Central Precocious Puberty
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 79
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 6 Months.
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.
timeFrame: 3 months
measure: Average LH and FSH concentrations at each time point, and the changes from baseline levels before administration.
timeFrame: Baseline, 3 and 6 months
measure: 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
timeFrame: 3 and 6 months
measure: Average concentrations of Estradiol or Testosterone at each time point, and the respective changes compared to before administration.
timeFrame: Baseline, 3 and 6 months
measure: Average bone age/chronological age ratio at 6 months after administration, and the changes compared to before administration.
timeFrame: 6 months
measure: Average Tanner Stage at 6 months after administration, and the changes compared to before administration.
timeFrame: 6 months
measure: Average growth velocity (cm/year, annualized height velocity) at 6 months after administration, and the changes compared to before administration.
timeFrame: 6 months
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University medical center
Study officials:
affiliation: Ajou University School of Medicine
name: Jin Soong Hwang, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References: