Evaluate the Efficacy and Safety of DWJ108J

NCT06025409 | Unknown Phase 3

• 1 other identifier: DW_DWJ108J301
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Central Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of Participants With Suppression of Peak-Stimulated Luteinizing Hormone at 3 Months.

  3 months

• 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

  3 and 6 months

• 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.

  6 months

Study Arms (1)

Experimental: Leuprorelin

EXPERIMENTAL

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

Interventions

Leuprolide Acetate 11.25 MG/ML DRUG

Subcutaneous injection

Experimental: Leuprorelin

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Exhibited pubertal response of LH (peak ≥ 5 IU/L) during GnRH stimulation test at screening
• Diagnosis of central precocious puberty
• 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
• Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year
• In cases where the legal guardian of the child listened to the explanation of this clinical trial and provided written consent

You may not qualify if:

• 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
• requires treatment within 6 months of receiving a registration number during the trial period that could affect the hypothalamic-pituitary-gonadal axis
• Prior treatment with GnRH analogues
• Hypersensitive to the investigational drug for this clinical trial or GnRH analogues
• Prior or current therapy with growth hormone
• 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
• 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
• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Ajou University medical center

Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Jin Soong Hwang, MD. PhD

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeonseo Choi, MD. PhD

CONTACT

82-2-550-8800; yeonseo@daewoong.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 6, 2023
• Study Start: August 1, 2023
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)