A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

• ClinicalTrials.gov Identifier: NCT04757376
• Recruitment Status: Active, not recruiting
• First Posted: February 17, 2021
• Last Update Posted: August 15, 2023
• Sponsor: Celltrion
• Information provided by (Responsible Party): Celltrion

Study Description

Brief Summary:

This study is a Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women with Osteoporosis

Condition or disease	Intervention/treatment	Phase
Postmenopausal Women With Osteoporosis	Biological: CT-P41; Biological: US-licensed Prolia	Phase 3

Detailed Description:

This is a double-blind, randomized, active-controlled, Phase 3 study to evaluate the efficacy, PK, PD, and safety including immunogenicity of CT-P41 compared with US-licensed Prolia in postmenopausal women with osteoporosis. All patients will also receive daily supplementation containing at least 1,000 mg of elemental calcium and at least 400 IU vitamin D from randomization to EOS visit and the data will be collected via patient's diary.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 479 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Active-controlled, Phase 3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics, and Safety of CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis
• Actual Study Start Date: June 17, 2021
• Actual Primary Completion Date: May 18, 2023
• Estimated Study Completion Date: November 16, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: CT-P41; 60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS)	Biological: CT-P41; 60 mg/mL single dose, Solution for injection in PFS
Active Comparator: US-licensed Prolia; 60 mg/mL single dose administration, Solution for injection in PFS	Biological: US-licensed Prolia; 60 mg/mL single dose, Solution for injection in PFS

Outcome Measures

Primary Outcome Measures :

1. demonstrate efficacy equivalence [ Time Frame: Week 52 ]
   percent change from baseline in bone mineral density (BMD) for lumbar spine (L1 to L4)
2. demonstrate pharmacodynamics(PD) similarity [ Time Frame: from Day 1 predose to Week 26 predose ]
   area under the effect curve (AUEC) of serum carboxy-terminal cross-linking telopeptide of type I collagen (s-CTX)

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Women, 50 to 80 years of age, both inclusive.
2. Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
3. Postmenopausal
4. Bone mineral density T-score ≤ - 2.5 and ≥ - 4.0 at the lumbar spine (L1 to L4) as assessed by the central imaging vendor based on dual-energy X-ray absorptiometry(DXA) scan.
5. Patients must have at least 3 vertebrae considered evaluable at the lumbar spine (L1 to L4) and at least 1 hip considered evaluable by DXA scan assessed by the central imaging vendor. Patients with unilateral metal in hips that would be allowed for the other side of 1 evaluable hip are included.
6. Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

Exclusion Criteria:

1. Patient previously received denosumab, any other monoclonal antibodies, or biologic agents for osteoporosis
2. Patient confirmed or suspected with infection of COVID-19 at Screening, or has contact with COVID-19 patient within 14 days from Screening
3. Patient with history and/or presence of one severe or > 2 moderate vertebral fractures as determined by central reading of lateral spine X-ray
4. Patient with history and/or presence of hip fracture
5. Patient with history and/or presence of hyperparathyroidism or hypoparathyroidism, irrespective of current controlled or uncontrolled status
6. Patient with current hyperthyroidism (unless well controlled on stable antithyroid therapy)
7. Patient with current hypothyroidism (unless well controlled on stable thyroid replacement therapy)
8. Patient with history and/or presence of bone disease and metabolic disease (except for osteoporosis) that may interfere with the interpretation of the results

Contacts and Locations

Locations

Estonia

KLV Arstikabinet

Parnu, Estonia, 80010

Sponsors and Collaborators

Celltrion

More Information

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04757376
• Other Study ID Numbers: CT-P41 3.1; 2020-005974-91 ( EudraCT Number )
• First Posted: February 17, 2021
• Last Update Posted: August 15, 2023
• Last Verified: August 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Denosumab; Bone Density Conservation Agents; Physiological Effects of Drugs