A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP)

Central Precocious Puberty (CPP) Clinical Trial

Official title:

A Phase 3, Multicenter, Open-Label, Two-Part Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty (CPP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695237
• Other study ID #: M16-904
• Status: Completed
• Phase: Phase 3
• Start date: October 24, 2018
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to assess the safety and efficacy of a leuprolide acetate (LA) 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) or who have been previously treated with a GnRHa.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 29, 2023
• Est. primary completion date: May 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children with CPP who are naïve to treatment with a gonadotropin-releasing hormone agonist (GnRHa) (females 2 - 8 years of age, or males 2 - 9 years of age) or who have been on standard GnRHa therapy for at least 6 months (females 2 - 10 years of age, or males 2 - 11 years of age).
• No history of clinically significant medical conditions or any other reason that the investigator determines would make the participant an unsuitable candidate to receive study drug.

Related Conditions & MeSH terms

• Central Precocious Puberty (CPP)
• Puberty, Precocious

Intervention

Drug:
• Leuprolide Acetate (LA)
Administered intramuscularly as an injection

Locations

Country	Name	City	State
Puerto Rico	Pediatric Endocrine Research Associates /ID# 200131	San Juan
United States	Van Meter Pediatric Endocrinology /ID# 201688	Atlanta	Georgia
United States	Children's Hospital Colorado /ID# 201645	Aurora	Colorado
United States	Pediatric Endocrine Associates /ID# 202396	Boston	Massachusetts
United States	UBMD - Pediatrics /ID# 201978	Buffalo	New York
United States	Cook Children's Med. Center /ID# 212937	Fort Worth	Texas
United States	Pediatric Endocrine Associates /ID# 201089	Greenwood Village	Colorado
United States	Penn State Hershey Medical Ctr /ID# 200287	Hershey	Pennsylvania
United States	Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878	Idaho Falls	Idaho
United States	Indiana University /ID# 200526	Indianapolis	Indiana
United States	Nemours Children's Health System /ID# 201331	Jacksonville	Florida
United States	Children's Mercy Hospital and Clinics /ID# 200221	Kansas City	Missouri
United States	Pediatric Endocrinology Associates /ID# 200629	Long Beach	California
United States	University of Minnesota /ID# 200508	Minneapolis	Minnesota
United States	The Mount Sinai Hospital /ID# 200675	New York	New York
United States	Arnold Palmer Hospital /ID# 201624	Orlando	Florida
United States	Children's Hospital of Philadelphia - Main /ID# 203846	Philadelphia	Pennsylvania
United States	Rady Children's Hospital San Diego /ID# 202491	San Diego	California
United States	MultiCare Institute Health System /ID# 202188	Tacoma	Washington
United States	University of Oklahoma /ID# 200659	Tulsa	Oklahoma
United States	UMass Chan Medical School /ID# 203327	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24	Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg.; Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test.; Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.	Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Secondary	Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48	Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg.; Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test.; Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.	Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Secondary	Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48	Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48).	Weeks 12, 20, 24, 44, and 48
Secondary	Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48	Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48).	Weeks 12, 20, 24, 44, and 48
Secondary	Part 1: Percentage of Participants With Suppression of the Physical Signs of Puberty	Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics).; Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging.; Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging.	Weeks 24 and 48
Secondary	Part 1: Change From Baseline in Incremental Growth Rate	Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used.	Baseline and Weeks 4, 12, 20, 24, 44, and 48
Secondary	Part 1: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age	Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system.; A ratio less than 1 indicates less advancement of bone age compared to chronological age.	Baseline and Weeks 24 and 48
Secondary	Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)		Weeks 72, 96, 120, and 144
Secondary	Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL		Weeks 72, 96, 120, and 144
Secondary	Part 2: Percentage of Male Participants With Maintenance of Suppression of Testosterone to < 30 ng/dL	Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed	Weeks 72, 96, 120, and 144

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