Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty

May 1, 2024 updated by: Foresee Pharmaceuticals Co., Ltd.

An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety, and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients With Central (Gonadotropin-Dependent) Precocious Puberty (Casppian Study)

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with central (gonadotropin-dependent) precocious puberty, when administered as two injections six months apart.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, open-label, single-arm study. All subjects will be pediatric patients with central precocious puberty judged to be candidates for GnRH (gonadotropin releasing hormone) analog therapy, and all will receive two injections of FP-001 42 mg six-month apart in an unblinded fashion.

Study Type

Interventional

Enrollment (Estimated)

93

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center
        • Principal Investigator:
          • Xiumin Wang, MD
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Rongxiu Zheng, Doctor
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • The Second Hospital of Anhui Medical University
        • Contact:
          • Deyun Liu, Doctor
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital, Tongji Medical College of HUST
        • Contact:
          • Xiaoping Luo, Doctor
      • Wuhan, Hubei, China
        • Recruiting
        • Wuhan Children's Hospital, Tongji Medical College of HUST
        • Contact:
          • Hui Yao, Doctor
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Children's Hospital
        • Contact:
          • Yan Zhong, Doctor
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • Recruiting
        • University Pediatric Hospital
        • Contact:
        • Principal Investigator:
          • Francisco Nieves-Rivera, MD
  • Taiwan
      • Changhua City, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital
        • Principal Investigator:
          • Yi-Lei Wu, MD
      • Kaohsiung City, Taiwan, 704302
        • Recruiting
        • Chang Gung Memorial Hospital-Kaohsiung branch
        • Principal Investigator:
          • Ying-Hua Huang, MD
      • Taipei City, Taiwan, 104217
        • Recruiting
        • Mackay Memorial Hospital
        • Principal Investigator:
          • Wei-Hsin Ting, MD
      • Taoyuan City, Taiwan, 333423
        • Recruiting
        • LinKou Chang-Gung Memorial Hospital (CGMH-LK)
        • Principal Investigator:
          • Fu-Sung Lo, MD
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Arizona University
        • Principal Investigator:
          • Mark Wheeler, MD
        • Contact:
    • California
      • San Diego, California, United States, 92123
        • Recruiting
        • Rady Children's Hospital- San Diego
        • Contact:
        • Principal Investigator:
          • Marcela Vargas Trujillo, MD
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Nemours Children's Health Center
        • Principal Investigator:
          • Lournaris Torres Santiago, MD
        • Contact:
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins - All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Supamit Ukarapong, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Rocky Mountain Clinical Research
        • Principal Investigator:
          • Joshua Smith, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Erica Eugster, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • University of Minnesota
        • Principal Investigator:
          • Bradley Miller, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Principal Investigator:
          • Perrin White, MD
        • Contact:
      • Fort Worth, Texas, United States, 76104
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • Virginia University
        • Principal Investigator:
          • David Repaske, MD
        • Contact:
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Health System
        • Contact:
        • Principal Investigator:
          • Bhuvana Sunil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 9 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
  2. Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
  3. Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation > 5 mIU/mL.
  4. Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
  5. Willing and able to participate in the study.
  6. Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
  7. Bone age < 13 years for girls and < 14 years for boys.
  8. Signed Institutional Review Board/Independent Ethics Committee (IRB/IEC)-approved informed consent form (ICF) by one or both parents (per IRB/IEC requirements), by the custodial parent(s) or by the legal guardian(s) (if required).
  9. Signed Assent by patients as per IRB/IEC requirements.

Exclusion Criteria:

  1. Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion. This includes true CPP triggered by other conditions, such as congenital adrenal hyperplasia.
  2. Prior or current GnRH treatment for CPP.
  3. Non-progressing isolated premature thelarche.
  4. Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Patients with hamartomas or adenomas not requiring surgery are eligible.
  5. Any other condition, chronic illness or treatment that, in the opinion of the Investigator, may interfere with growth or other study endpoints (e.g., chronic steroid use [except mild topical steroids], renal failure, diabetes, moderate to severe scoliosis, previously treated intracranial tumor).
  6. Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
  7. Major medical or psychiatric illness that could interfere with study visits.
  8. Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
  9. Positive urine pregnancy test.
  10. Known hypersensitivity to GnRH or related compounds.
  11. Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study.
  12. Any other condition(s) which could significantly interfere with Protocol compliance.
  13. Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0).
  14. Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions.
  15. Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per Investigator opinion, have been associated with seizures or convulsions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FP-001 42 mg
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).
Drug: Leuprolide Mesylate, Subcutaneous injection of 42 mg Leuprolide
All subjects will be pediatric patients with central precocious puberty. They will be injected twice with a depot formulation containing 42 mg of Leuprolide. The first dose on day 0 the second dose on week 24 (six months apart).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
Time Frame: 48 weeks
The percentage of patients with serum LH concentrations < 4 mIU/mL 60 minutes following an abbreviated GnRHa stimulation test at Visit 6 (Week 24).
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of FP-001 42 mg on bone age progression
Time Frame: 24 and 48 weeks
Evaluate the changes in bone age progression from the baseline to Weeks 24 and 48 using centralized analysis of wrist x-ray
24 and 48 weeks
Effect of FP-001 42 mg on growth rate
Time Frame: 48 weeks
Evaluate the changes in growth rate and bone age advancement relative to chronological age from baseline to end of study using height in meters
48 weeks
Effect of FP-001 42 mg on physical signs of puberty
Time Frame: 48 weeks
Evaluate the change in physical signs of puberty as measure by Tanner stages from baseline to end of study
48 weeks
Effect of FP-001 42 mg on suppression of physical signs of puberty
Time Frame: 48 weeks
Evaluate the percentage of patients with suppression of physical signs of puberty
48 weeks
Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH
Time Frame: 48 weeks
Evaluate The proportion of subjects exhibiting "acute-on-chronic" phenomenon (i.e., related to the second dose of FP-001 42 mg)
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foresee Pharmaceuticals Co., Ltd.

Collaborators

QPS Holdings LLC
Changchun GeneScience Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Susan Whitaker, Foresee Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2023

Primary Completion (Estimated)

October 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 9, 2022

Study Record Updates

Last Update Posted (Actual)

May 2, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP-001-CP-001

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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