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

NCT04757376 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: CT-P41 3.12020-005974-91
• Study Type: interventional
• Target: 479
• Locations: 4 countries
• Sites: 20

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

Conditions

Postmenopausal Women With Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52 - Full Analysis Set (FAS)

  Bone mineral density was assessed by dual-energy X-ray absorptiometry (DXA) and assessments of the lumbar spine (L1 to L4) were performed at a central imaging vendor. To evaluate the difference between 2 groups in the primary efficacy endpoint, the percent change from baseline in BMD for lumbar spine (L1 to L4) by DXA at Week 52 was analyzed using an analysis of covariance (ANCOVA) model coupled with multiple imputation assuming the data to be missing at random (MAR).

  baseline (screening), Week 52 predose

Secondary Outcomes (13)

• Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 52 - FAS

  baseline (screening), Week 52 predose

• Percent Change From Baseline in Lumbar Spine, Total Hip, and Femoral Neck BMD at Week 78 - FAS-TP II Subset

  baseline (screening), Week 78

• Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP I - FAS

  up to Week 52 predose

• Incidence of New Vertebral, Nonvertebral, and Hip Fractures During TP II - FAS-TP II Subset

  from Week 52 to Week 78

• Trough Serum Concentration (Ctrough) of Denosumab at Weeks 0 and 26 - Pharmacokinetic (PK) Set

  Week 0 Day 1 predose, Week 26 predose

Study Arms (2)

CT-P41

EXPERIMENTAL

60 mg/mL single dose administration, Solution for injection in prefilled syringe(PFS)

Biological: CT-P41

US-licensed Prolia

ACTIVE COMPARATOR

60 mg/mL single dose administration, Solution for injection in PFS

Biological: US-licensed Prolia

Interventions

CT-P41 BIOLOGICAL

60 mg/mL single dose, Solution for injection in PFS

CT-P41

US-licensed Prolia BIOLOGICAL

60 mg/mL single dose, Solution for injection in PFS

US-licensed Prolia

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women, 50 to 80 years of age, both inclusive.
• Body weight between 40.0 and 99.9 kg, both inclusive, when rounded to the nearest tenth.
• Postmenopausal
• 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.
• 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.
• Patient with albumin-adjusted total serum calcium ≥ 8.5 mg/dL (≥ 2.125 mmol/L) at Screening.

You may not qualify if:

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

Sponsors & Collaborators

• Celltrion: lead

Study Sites (20)

Center For Clinical And Basic Research

Tallinn, Harju, 10128, Estonia

Location

East Tallinn Central Hospital-Ravi 18

Tallinn, Harju, 11312, Estonia

Location

Clinical Research Centre Ltd

Tartu, Tartu, 50106, Estonia

Location

KLV Arstikabinet

Pärnu, 80010, Estonia

Location

Health Center Association, Medical Center Liepaja

Liepāja, 3401, Latvia

Location

Health Center 4-117 K. Barona Str

Riga, 1012, Latvia

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, 60-702, Poland

Location

Centrum Medyczne Poznan - PRATIA - PPDS

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Krakowskie Centrum Medyczne

Krakow, Lesser Poland Voivodeship, 31-501, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

Location

SOMED CR Sp. z o.o. Sp. Komandytowa - Lodz

Lódz, Lódzkie, 90-368, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Masovian Voivodeship, 01-192, Poland

Location

SOMED CR Sp. z o.o. Sp. Komandytowa - Warszawa

Warsaw, Masovian Voivodeship, 01-737, Poland

Location

NZOZ Osteo Medic SC Artur Racewicz Jerzy Supronik

Bialystok, Podlaskie Voivodeship, 15-351, Poland

Location

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, Pomeranian Voivodeship, 81-537, Poland

Location

MCM Krakow - PRATIA - PPDS

Krakow, 30-510, Poland

Location

AES - AS - Medical Center of Edelweiss Medics LLC

Kyiv, 02002, Ukraine

Location

Clinic of SI Institute of Gerontology n.a. D.F.Chebotaryov of NAMS of Ukraine

Kyiv, 04114, Ukraine

Location

AES - AS - Medical Center of Medbud - Clinic LLC

Kyiv, Ukraine

Location

Clinic of SRI of Invalid Rehab. (ESTC) of VNMU n.a. M.I.Pyrohov

Vinnytsia, 21029, Ukraine

Location

Results Point of Contact

• Title: Head of Clinical Planning Department
• Organization: CELLTRION, Inc.

jeehye.suh@celltrion.com

+82 32 850 4167

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: June 17, 2021
• Primary Completion: May 18, 2023
• Study Completion: November 16, 2023
• Last Updated: June 14, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Locations

ES (4); PL (10); UA (4); LA (2)