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

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Primary Purpose

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Leuprolide Acetate (LA)

About this trial

This is an interventional treatment trial for Central Precocious Puberty (CPP) focused on measuring Central Precocious Puberty (CPP), Leuprolide Acetate (LA)

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

None

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Leuprolide Acetate (LA)

Arm Description

Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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).

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.

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.

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.

Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)

Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL

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

Full Information

NCT ID

NCT03695237

First Posted

October 2, 2018

Last Updated

May 12, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03695237

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 24, 2018 (Actual)

Primary Completion Date

May 6, 2021 (Actual)

Study Completion Date

November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Precocious Puberty (CPP)

Keywords

Central Precocious Puberty (CPP), Leuprolide Acetate (LA)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Leuprolide Acetate (LA)

Arm Type

Experimental

Arm Description

Participants received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 144 weeks.

Intervention Type

Drug

Intervention Name(s)

Leuprolide Acetate (LA)

Other Intervention Name(s)

Lupron Depot

Intervention Description

Administered intramuscularly as an injection

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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.

Title

Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48

Description

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).

Time Frame

Weeks 12, 20, 24, 44, and 48

Title

Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48

Description

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).

Time Frame

Weeks 12, 20, 24, 44, and 48

Title

Part 1: Percentage of Participants With Suppression of the Physical Signs of Puberty

Description

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.

Time Frame

Weeks 24 and 48

Title

Part 1: Change From Baseline in Incremental Growth Rate

Description

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.

Time Frame

Baseline and Weeks 4, 12, 20, 24, 44, and 48

Title

Part 1: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age

Description

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.

Time Frame

Baseline and Weeks 24 and 48

Title

Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)

Time Frame

Weeks 72, 96, 120, and 144

Title

Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL

Time Frame

Weeks 72, 96, 120, and 144

Title

Part 2: Percentage of Male Participants With Maintenance of Suppression of Testosterone to < 30 ng/dL

Description

Male participants with maintenance of suppression of testosterone to < 30 ng/dL are assessed

Time Frame

Weeks 72, 96, 120, and 144

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ABBVIE INC.

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Pediatric Endocrinology Associates /ID# 200629

City

Long Beach

State/Province

California

ZIP/Postal Code

90806-1651

Country

United States

Facility Name

Rady Children's Hospital San Diego /ID# 202491

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Children's Hospital Colorado /ID# 201645

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Pediatric Endocrine Associates /ID# 201089

City

Greenwood Village

State/Province

Colorado

ZIP/Postal Code

80111

Country

United States

Facility Name

Nemours Children's Health System /ID# 201331

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Arnold Palmer Hospital /ID# 201624

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Van Meter Pediatric Endocrinology /ID# 201688

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30318-2538

Country

United States

Facility Name

Rocky Mountain Diabetes and Osteoporosis Center /ID# 209878

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404-7596

Country

United States

Facility Name

Indiana University /ID# 200526

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Pediatric Endocrine Associates /ID# 202396

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

UMass Chan Medical School /ID# 203327

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

University of Minnesota /ID# 200508

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455-0356

Country

United States

Facility Name

Children's Mercy Hospital and Clinics /ID# 200221

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

UBMD - Pediatrics /ID# 201978

City

Buffalo

State/Province

New York

ZIP/Postal Code

14203

Country

United States

Facility Name

The Mount Sinai Hospital /ID# 200675

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

University of Oklahoma /ID# 200659

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135-2527

Country

United States

Facility Name

Penn State Hershey Medical Ctr /ID# 200287

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033-2360

Country

United States

Facility Name

Children's Hospital of Philadelphia - Main /ID# 203846

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104-4319

Country

United States

Facility Name

Cook Children's Med. Center /ID# 212937

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

MultiCare Institute Health System /ID# 202188

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Pediatric Endocrine Research Associates /ID# 200131

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing URL

https://vivli.org/ourmember/abbvie/

Links:

URL

http://www.rxabbvie.com/

Description

Related Info

Central Precocious Puberty (CPP)

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial