Efficacy, Safety, and Pharmacokinetics of Leuprolide Mesylate in Subjects With Central Precocious Puberty
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)
1 other identifier
interventional
93
4 countries
41
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2023
Typical duration for phase_3
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedStudy Start
First participant enrolled
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedSeptember 19, 2025
September 1, 2025
2.4 years
August 4, 2022
September 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of Leuprolide Mesylate (FP-001 42 mg)
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 Outcomes (5)
Effect of FP-001 42 mg on bone age progression
24 and 48 weeks
Effect of FP-001 42 mg on growth rate
48 weeks
Effect of FP-001 42 mg on physical signs of puberty
48 weeks
Effect of FP-001 42 mg on suppression of physical signs of puberty
48 weeks
Acute-On-Chronic (AOC) phenomenon of serum testosterone and LH
48 weeks
Study Arms (1)
FP-001 42 mg
EXPERIMENTALAll 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).
Interventions
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).
Eligibility Criteria
You may qualify if:
- Females aged 2 to 8 years (inclusive) or males aged 2 to 9 years (inclusive).
- Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRHa treatment for CPP.
- Pubertal-type LH response at 60 minutes post GnRHa stimulation test before treatment initiation \> 5 mIU/mL.
- Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males.
- Willing and able to participate in the study.
- Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year.
- Bone age \< 13 years for girls and \< 14 years for boys.
- 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).
- Signed Assent by patients as per IRB/IEC requirements.
You may not qualify if:
- 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.
- Prior or current GnRH treatment for CPP.
- Non-progressing isolated premature thelarche.
- 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.
- 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).
- Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1).
- Major medical or psychiatric illness that could interfere with study visits.
- Diagnosis of short stature (i.e., 2.25 standard deviations (SD) below the mean height for age).
- Positive urine pregnancy test.
- Known hypersensitivity to GnRH or related compounds.
- 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.
- Any other condition(s) which could significantly interfere with Protocol compliance.
- Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0).
- Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions.
- Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per Investigator opinion, have been associated with seizures or convulsions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Foresee Pharmaceuticals Co., Ltd.lead
- QPS Holdings LLCcollaborator
- Changchun GeneScience Pharmaceutical Co., Ltd.collaborator
Study Sites (41)
Arizona University
Tucson, Arizona, 85719, United States
Rady Children's Hospital- San Diego
San Diego, California, 92123, United States
Nemours Children's Health Center
Jacksonville, Florida, 32207, United States
Johns Hopkins - All Children's Hospital
St. Petersburg, Florida, 33701, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Cook Children's
Fort Worth, Texas, 76104, United States
Virginia University
Charlottesville, Virginia, 22908, United States
Multicare Health System
Tacoma, Washington, 98405, United States
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Children's Hospital affiliated to Capital Institute of Pediatrics
Beijing, Chaoyang District, China
The first Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Pearl River Hospital, Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
Wuhan Children's Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Children's Hospital of Shanxi
Taiyuan, Shanxi, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
The Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
Ningbo Women & Children's Hospital
Ningbo, Zhejiang, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Children's Hospital of Fudan University
Shanghai, China
Children's Hospital of Shanghai
Shanghai, China
Shanghai Children's Medical Center
Shanghai, China
Tianjin Medical University General Hospital
Tianjin, China
University Pediatric Hospital
San Juan, 00935, Puerto Rico
Changhua Christian Hospital
Changhua, 50006, Taiwan
Chang Gung Memorial Hospital-Kaohsiung branch
Kaohsiung City, 704302, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Mackay Memorial Hospital
Taipei, 104217, Taiwan
LinKou Chang-Gung Memorial Hospital (CGMH-LK)
Taoyuan, 333423, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bassem Elmankabadi
Foresee Pharma
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 4, 2022
First Posted
August 9, 2022
Study Start
June 2, 2023
Primary Completion
November 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share