Efficacy and Safety of MW031 in PMO Subjects

NCT05215977 | Completed Phase 3 DMC

• 1 other identifier: MW031-2019-CP301
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW031 in Chinese postmenopausal osteoporotic subjects with increased bone fracture risk .

Conditions

Osteoporosis, Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months

  Dual energy x-ray absorptiometry (DXA) is applied for Bone mineral density (BMD) assessment.

  Baseline and Month 12

Secondary Outcomes (3)

• Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months

  Baseline and Month 6

• Percent change in BMD at the total hip, femoral neck from Baseline up to 6 months and 12 months

  Baseline, Month 6 and Month 12

• Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 12 months

  Baseline, Month 1, Month 3, Month 6, Month 9 and Month 12

Study Arms (2)

MW031

EXPERIMENTAL

MW031 injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial, according to the investigator's assessment.

Drug: MW031

placebo

PLACEBO COMPARATOR

Placebo was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.

Drug: Placebo

Interventions

MW031 DRUG

The active ingredient of MW031 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU

Also known as: Recombinant anti-RANKL human monoclonal antibody injection

MW031

Placebo DRUG

subcutaneous injection of 60 mg (1.0 mL)every 6 months for a maximum of 2 consecutive doses throughout the trial. Dietary Supplement: Elemental Calcium Oral, at least1000 mg Dietary Supplement: Vitamin D Oral, 400 IU

placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMD -4.0\<T-score ≤-2.5 at either the lumbar spine or total hip or femoral neck
• All subjects must have at least one of following additional the risk factors:history of fracture, parental history of hip fracture, increased bone turnover rate at screening, low body weight, elderly (age≥65year)，current smoker
• Postmenopausal is defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea, or bilateral oophorectomy \>2 years after surgery. If bilateral oophorectomy status is unknown, use follicle-stimulating hormone (FSH) levels \> 40 mIU/mL to confirm surgical postmenopausal status.

You may not qualify if:

• Bone/metabolic disease
• Hyperparathyroidism or hypoparathyroidism
• Thyroid condition: Hyperthyroidism or hypothyroidism
• Rheumatoid arthritis
• Malignant tumors
• Malabsorption syndrome
• Oral bisphosphonates

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (1)

Peking Union Hospital

Beijing, Beijing Municipality, 100000, China

Location

Related Publications (1)

• Jiang Y, Huo Y, Li Y, Kong X, Wang B, Liu F, Zheng X, Li Y, Yang Y, Xu Y, Xue Q, Hu Z, Xiao Y, Ma W, Guo Y, Yu W, Xia W. Randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of the denosumab biosimilar MW031 in Chinese postmenopausal women with osteoporosis. Expert Opin Biol Ther. 2024 Jul;24(7):665-672. doi: 10.1080/14712598.2024.2352587. Epub 2024 May 16.

  PMID: 38752402 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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: January 18, 2022
• First Posted: January 31, 2022
• Study Start: December 27, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)