ESCALATE: A Study to Investigate the Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06024967
• Collaborator: (none)
• Enrollment: 180
• Arm: 1
• Anticipated Duration (Months): 21

Study Details

Study Description

Brief Summary

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Condition or Disease	Intervention/Treatment	Phase
GHD	Drug: PEG-somatropin	Phase 3

Detailed Description

The purpose of this Phase 3 study is to evaluate the safety and efficacy of once-weekly GenSci004 over 108 weeks in children with GHD aged from 6 months to 17 years old, inclusive.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Safety and Efficacy of Once-weekly PEG-somatropin (GenSci004) in Children With Growth Hormone Deficiency: An Open-label, Single-arm, Multicenter Phase 3 Study
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: May 1, 2025
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GenSci004	Drug: PEG-somatropin; PEG-somatropin

Outcome Measures

Primary Outcome Measures

1. Adverse Events of once-weekly GenSci004 in children with GHD [108 weeks]

   Incidents of adverse events

Secondary Outcome Measures

1. Annualized Height Velocity (AHV) [104 weeks]

   Measured in centimeter per year (cm/year)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Investigator-determined diagnosis of GHD prior to the historical initiation of daily rhGH trerapy

2. Participant must be 6 months to 17 years old

3. Tanner stage <5 at Visit 1

4. Open epiphyses

5. Normal fundoscopy at Screening

6. Written, signed, informed consent of the participant's parent(s)/LAR(s) and written assent of the participant

Exclusion Criteria:

1. History or presence of malignant disease

2. Children with diabetes mellitus

3. Major medical conditions and/or presence of contraindications to GH treatment

4. Pregnancy

5. Participation in any other study of an investigational agent within three months prior to Visit 1

6. Prior exposure to investigational drug or any other long-acting growth hormone

7. Any other reason per investigator's discretion

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.

Investigators

• Study Chair: Lawrence Silverman, MD, Morristown Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Changchun GeneScience Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06024967
• Other Study ID Numbers: GenSci004-302
• First Posted: Sep 6, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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.: Yes
• Keywords provided by Changchun GeneScience Pharmaceutical Co., Ltd.: GHD; growth hormone deficiency

Study Results

No Results Posted as of Sep 11, 2023