Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05853354
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-05-02
Brief Title:
Comparative Efficacy Safety PK and Immunogenicity Study
Sponsor:
Luye Pharma Group Ltd
Organization:
Luye Pharma Group Ltd
Study Overview
Official Title:
A Randomized Double-blind Parallel-group Active-controlled Comparative Study to Evaluate the Efficacy Safety Pharmacokinetics and Immunogenicity of LY06006 Compared With EU-Prolia in Postmenopausal Women With Osteoporosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy pharmacodynamic PD safety PK and immunogenicity in postmenopausal women with osteoporosis
Detailed Description:
This is a randomized double-blind parallel-group active-controlled comparative study Main Period with a Transition Period to compare the efficacy PD safety PK and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis
Participants will go through a Screening Period within 35 days prior to first dosing After signing the informed consent form ICF participants will be screened for age menopausal status and vitamin D levels in addition to other inclusionexclusion criteria Participants will also undergo a screening DXA examination Eligibility is based on the absolute value consistent with a T-score -25 and -40 at the lumbar spine
Main Period Upon completing all screening assessments and meeting all eligibility criteria participants will enter the Main Period of the study The Main Period will last 12 months where participants will be randomized in a 11 ratio to receive either a dose 60 mg1 mL of LY06006 or EU-Prolia subcutaneously at the Baseline Visit Day 1 and Month 6 All participants will receive daily supplements of elemental calcium at least 1000 mg and vitamin D at least 400 IU Study visits will occur at the Baseline Visit Day 1 and at Months 05 1 2 3 6 9 and 12
Follow-up BMD assessment will be done at Months 6 and 12 Blood sampling for PD safety PK and immunogenicity will be done at the Baseline Visit Day 1 and at Months 05 1 2 3 6 9 and 12
Transition Period The Transition Period will be conducted in all participants who completed the Main Period of the study At Month 12 participants who received EU-Prolia in the Main Period will be re-randomized in a 11 ratio to either be transitioned to receive a dose of LY06006 or continue on EU-Prolia subcutaneously Participants who received LY06006 in the Main Period will be re-randomized to continue to receive LY06006 in the Transition Period All participant assignment during the Transition Period will be performed via the interactive response technology IRT system to maintain the blind of treatment assignment
Blood sampling for PD safety PK and immunogenicity will be done at Months 15 PK and immunogenicity only and 18 End of study EoS assessments will be performed at Month 18 or at the time of early discontinuation or withdrawal of the participant The duration of the clinical phase for participants from the Screening Period until the EoS Visit is approximately 19 months up to 5 weeks of Screening Period 12 months of Main Period and 6 months of Transition Period
Participants will go through a Screening Period within 35 days prior to first dosing After signing the informed consent form ICF participants will be screened for age menopausal status and vitamin D levels in addition to other inclusionexclusion criteria Participants will also undergo a screening DXA examination Eligibility is based on the absolute value consistent with a T-score -25 and -40 at the lumbar spine
Main Period Upon completing all screening assessments and meeting all eligibility criteria participants will enter the Main Period of the study The Main Period will last 12 months where participants will be randomized in a 11 ratio to receive either a dose 60 mg1 mL of LY06006 or EU-Prolia subcutaneously at the Baseline Visit Day 1 and Month 6 All participants will receive daily supplements of elemental calcium at least 1000 mg and vitamin D at least 400 IU Study visits will occur at the Baseline Visit Day 1 and at Months 05 1 2 3 6 9 and 12
Follow-up BMD assessment will be done at Months 6 and 12 Blood sampling for PD safety PK and immunogenicity will be done at the Baseline Visit Day 1 and at Months 05 1 2 3 6 9 and 12
Transition Period The Transition Period will be conducted in all participants who completed the Main Period of the study At Month 12 participants who received EU-Prolia in the Main Period will be re-randomized in a 11 ratio to either be transitioned to receive a dose of LY06006 or continue on EU-Prolia subcutaneously Participants who received LY06006 in the Main Period will be re-randomized to continue to receive LY06006 in the Transition Period All participant assignment during the Transition Period will be performed via the interactive response technology IRT system to maintain the blind of treatment assignment
Blood sampling for PD safety PK and immunogenicity will be done at Months 15 PK and immunogenicity only and 18 End of study EoS assessments will be performed at Month 18 or at the time of early discontinuation or withdrawal of the participant The duration of the clinical phase for participants from the Screening Period until the EoS Visit is approximately 19 months up to 5 weeks of Screening Period 12 months of Main Period and 6 months of Transition Period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 138591 | REGISTRY | None | None |
| 2022-002312-23 | EUDRACT_NUMBER | FDA | None |