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出境医 / 临床实验 / Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis

Study Description
Brief Summary:

This is a multicenter, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive 2 doses of either GP2411 or EU-authorized Prolia.

At the beginning of Treatment Period 2 (Week 52 to Week 78) patients in Treatment Period 1 Prolia group will be re-randomized 1:1 to either continue with a third dose of EU- authorized Prolia, or transition to GP2411. All patients in the GP2411 group will continue the treatment with a third dose of GP2411.


Condition or disease Intervention/treatment Phase
Postmenopausal Women With Osteoporosis Biological: GP2411 Biological: EU authorized Prolia Phase 3

Expanded Access : Sandoz has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : October 25, 2021
Estimated Study Completion Date : July 20, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: GP2411
60 mg /mL subcutaneous injection every 6 months
 Biological: GP2411
60 mg /mL subcutaneous injection every 6 months
Active Comparator: EU authorized Prolia
60 mg /mL subcutaneous injection every 6 months
 Biological: EU authorized Prolia
60 mg /mL subcutaneous injection every 6 months
Outcome Measures
Primary Outcome Measures :
  1. Percent change from baseline (%CfB) in lumbar spine Bone Mineral Density [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  2. Area under the effect versus time curve (AUEC) after first dose, percent change from baseline in serum Collagen C-telopeptide (CTX) [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  3. Serum PK parameter AUCinf after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  4. Serum PK parameter Cmax after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1


Secondary Outcome Measures :
  1. Percent change from baseline in Bone Mineral Density at femoral neck and total hip by DXA [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  2. CTX serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  3. Occurence of adverse events and serious adverse events [ Time Frame: Screening, Week 52 ]
    Treatment Period 1

  4. Anti-drug antibodies (ADAs) serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  5. Percent change from baseline of Bone Mineral density at lumbar spine, femoral neck and total hip by DXA [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2

  6. CTX serum concentration [ Time Frame: Week 52, week 78 ]
    Treatment Period 2

  7. Adverse events and serious adverse events [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2

  8. Procollagen 1 N-terminal propeptide (P1NP) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2

  9. P1NP serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1

  10. Antidrug antibodies (ADAs) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Postmenopausal women, diagnosed with osteoporosis
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women, diagnosed with osteoporosis
  • Aged ≥ 55 and ≤ 80 years at screening
  • Body weight ≥ 50 kg and ≤ 90 kg at screening
  • Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by DXA
  • At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA

Exclusion Criteria:

  • Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)
  • History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture
  • History and/or presence of bone metastases, bone disease or metabolic disease
  • Ongoing use of any osteoporosis treatment or use of prohibited treatment
  • Other bone active drugs
  • History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia

Other Inclusion/exclusion criteria may apply

Contacts and Locations

Locations
Layout table for location information
United States, Arizona
Sandoz Investigational Site
Peoria, Arizona, United States, 85381
United States, Florida
Sandoz Investigational Site
Miami, Florida, United States, 33135
United States, Kansas
Sandoz Investigational Site
Wichita, Kansas, United States, 67207
United States, Pennsylvania
Sandoz Investigational Site
Duncansville, Pennsylvania, United States, 16635
Sandoz Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, Texas
Sandoz Investigational Site
Carrollton, Texas, United States, 75010
Bulgaria
Sandoz Investigational Site
Plovdiv, Bulgaria, 4001
Sandoz Investigational Site
Plovdiv, Bulgaria, 4002
Sandoz Investigational Site
Sofia, Bulgaria, 1431
Sandoz Investigational Site
Sofia, Bulgaria, 1505
Sandoz Investigational Site
Sofia, Bulgaria, 1680
Sandoz Investigational Site
Sofia, Bulgaria, 1784
Czechia
Sandoz Investigational Site
Ostrava, Czech Republic, Czechia, 772 00
Sandoz Investigational Site
Hradec Kralove, CZE, Czechia, 500 05
Sandoz Investigational Site
Brno, Czechia, 602 00
Sandoz Investigational Site
Ostrava, Czechia, 702 00
Sandoz Investigational Site
Pardubice, Czechia, 530 02
Sandoz Investigational Site
Plzen, Czechia, 30460
Sandoz Investigational Site
Praha 11, Czechia, 148 00
Sandoz Investigational Site
Praha 2, Czechia, 128 50
Sandoz Investigational Site
Uherske Hradiste, Czechia, 686 01
Japan
Sandoz Investigational Site
Fujimi, Saitama, Japan, 354-0021
Sandoz Investigational Site
Chuoh-ku, Tokyo, Japan, 104-0031
Sandoz Investigational Site
Hachioji-city, Tokyo, Japan, 192-0046
Sandoz Investigational Site
Kiyose-city, Tokyo, Japan, 204-0021
Sandoz Investigational Site
Shinagawa, Tokyo, Japan, 140-0014
Poland
Sandoz Investigational Site
Krakow, Malopolskie, Poland, 30-510
Sandoz Investigational Site
Bialystok, Poland, 15-351
Sandoz Investigational Site
Bialystok, Poland, 15-461
Sandoz Investigational Site
Bydgoszcz, Poland, 85 168
Sandoz Investigational Site
Lodz, Poland, 90 242
Sandoz Investigational Site
Nadarzyn, Poland, 05-830
Sandoz Investigational Site
Torun, Poland, 87-100
Sandoz Investigational Site
Warszawa, Poland, 00-874
Sandoz Investigational Site
Warszawa, Poland, 02 118
Sandoz Investigational Site
Warszawa, Poland, 02 691
Spain
Sandoz Investigational Site
Santiago de Compostela, A Coruna, Spain, 15705
Sandoz Investigational Site
Sabadell, Barcelona, Spain, 08208
Sandoz Investigational Site
Santiago de Compostela, Galicia, Spain, 15706
Sandoz Investigational Site
Barcelona, Spain, 08041
Sandoz Investigational Site
Madrid, Spain, 28009
Sandoz Investigational Site
Sevilla, Spain, 41010
Sponsors and Collaborators
Sandoz
Hexal AG
Tracking Information
First Submitted Date  ICMJE June 3, 2019
First Posted Date  ICMJE June 4, 2019
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE July 2, 2019
Estimated Primary Completion Date October 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Percent change from baseline (%CfB) in lumbar spine Bone Mineral Density [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Area under the effect versus time curve (AUEC) after first dose, percent change from baseline in serum Collagen C-telopeptide (CTX) [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Serum PK parameter AUCinf after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Serum PK parameter Cmax after first dose [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2019)
  • Percent change from baseline in Bone Mineral Density at femoral neck and total hip by DXA [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • CTX serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Occurence of adverse events and serious adverse events [ Time Frame: Screening, Week 52 ]
    Treatment Period 1
  • Anti-drug antibodies (ADAs) serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Percent change from baseline of Bone Mineral density at lumbar spine, femoral neck and total hip by DXA [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • CTX serum concentration [ Time Frame: Week 52, week 78 ]
    Treatment Period 2
  • Adverse events and serious adverse events [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • Procollagen 1 N-terminal propeptide (P1NP) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • P1NP serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Antidrug antibodies (ADAs) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Percent change from baseline in Bone Mineral Density at femoral neck and total hip by DXA [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • CTX serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Occurence of adverse events and serious adverse events [ Time Frame: Screening, Week 52 ]
    Treatment Period 1
  • Anti-drug antibodies (ADAs) serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Percent change from baseline of Bone Mineral density at lumbar spine, femoral neck and total hip by DXA [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • CTX serum concentration [ Time Frame: Week 52, week 78 ]
    Treatment Period 2
  • Adverse events and serious adverse events [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • Progollagen 1 N-terminal propeptide (P1NP) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
  • P1NP serum concentration [ Time Frame: Baseline, Week 52 ]
    Treatment Period 1
  • Antidrug antibodies (ADAs) serum concentration [ Time Frame: Week 52, Week 78 ]
    Treatment Period 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Investigating PK, PD, Efficacy, Safety, and Immunogenicity of Biosimilar Denosumab (GP2411) in Patients With Postmenopausal Osteoporosis
Official Title  ICMJE A Randomized, Double-blind, Multicenter Integrated Phase I/III Study in Postmenopausal Women With Osteoporosis to Compare the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety and Immunogenicity of GP2411 (Proposed Biosimilar Denosumab) and Prolia® (EU-authorized)
Brief Summary

This is a multicenter, randomized, parallel arm, double-blind study with a total duration up to 82 weeks. Approximately 522 postmenopausal patients with osteoporosis will be randomized at the beginning of Treatment Period 1 (Baseline to Week 52) to receive 2 doses of either GP2411 or EU-authorized Prolia.

At the beginning of Treatment Period 2 (Week 52 to Week 78) patients in Treatment Period 1 Prolia group will be re-randomized 1:1 to either continue with a third dose of EU- authorized Prolia, or transition to GP2411. All patients in the GP2411 group will continue the treatment with a third dose of GP2411.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
double blind
Primary Purpose: Treatment
Condition  ICMJE Postmenopausal Women With Osteoporosis
Intervention  ICMJE
  • Biological: GP2411
    60 mg /mL subcutaneous injection every 6 months
  • Biological: EU authorized Prolia
    60 mg /mL subcutaneous injection every 6 months
Study Arms  ICMJE
  • Experimental: GP2411
    60 mg /mL subcutaneous injection every 6 months
    Intervention: Biological: GP2411
  • Active Comparator: EU authorized Prolia
    60 mg /mL subcutaneous injection every 6 months
    Intervention: Biological: EU authorized Prolia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 26, 2021) 		527
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2019) 		522
Estimated Study Completion Date  ICMJE July 20, 2022
Estimated Primary Completion Date October 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Postmenopausal women, diagnosed with osteoporosis
  • Aged ≥ 55 and ≤ 80 years at screening
  • Body weight ≥ 50 kg and ≤ 90 kg at screening
  • Absolute bone mineral density consistent with T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine as measured by DXA
  • At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA

Exclusion Criteria:

  • Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab)
  • History and/or presence of one severe or more than two moderate vertebral fractures or hip fracture
  • History and/or presence of bone metastases, bone disease or metabolic disease
  • Ongoing use of any osteoporosis treatment or use of prohibited treatment
  • Other bone active drugs
  • History and/or current hypoparathyroidism or hyperparathyroidism, hypocalcemia or hypercalcemia

Other Inclusion/exclusion criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Postmenopausal women, diagnosed with osteoporosis
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Japan,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03974100
Other Study ID Numbers  ICMJE CGP24112301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Sandoz
Study Sponsor  ICMJE Sandoz
Collaborators  ICMJE Hexal AG
Investigators  ICMJE Not Provided
PRS Account Sandoz
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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