Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain

NCT03245008 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MT-5547-J01
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 27

Brief Summary

The objective of this study is to verify the superiority of 16 weeks of MT-5547 treatment to placebo, as evidenced by the WOMAC pain score (the efficacy outcome measure), in patients with osteoarthritis of the knee or hip. Additional objectives of the study are to investigate the efficacy, safety, and pharmacokinetics of MT-5547 in long-term use.

Conditions

Osteoarthritis, Knee / Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• WOMAC Pain Score (Change From Baseline at Week 16)

  The WOMAC is a scale that is used to assess the activities of daily living in osteoarthritis, the WOMAC pain subscale score was defined as the average of 5 items (during walking, using stairs, in bed, sitting or lying, and standing). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicated worse pain.

  Baseline to Week 16

Secondary Outcomes (8)

• WOMAC Physical Function Score (Change From Baseline at Week 16)

  Baseline to Week 16

• WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)

  Baseline to Week 68

• WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)

  Baseline to Week 68

• WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)

  Baseline to Week 68

• WOMAC Total Score (Change From Baseline at Each Assessment Time Point)

  Baseline to Week 68

Study Arms (3)

MT-5547 dosing regimen 1

EXPERIMENTAL

MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16.

Drug: MT-5547

MT-5547 dosing regimen 2

EXPERIMENTAL

MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16.

Drug: MT-5547; Drug: MT-5547-matching placebo

MT-5547-matching placebo

PLACEBO COMPARATOR

MT-5547-matching placebo SC dosing. Naproxen oral after Week 16.

Drug: MT-5547-matching placebo

Interventions

MT-5547-matching placebo DRUG

Solution for injection in pre-filled syringe

MT-5547 dosing regimen 2; MT-5547-matching placebo

MT-5547 DRUG

Solution for injection in pre-filled syringe

Also known as: Fasinumab

MT-5547 dosing regimen 1; MT-5547 dosing regimen 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Additional screening criteria check may apply for qualification:
• Male and female Japanese patients, 40 years to 85 years at the time written informed consent is obtained.
• Patients who have been diagnosed with osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology (ACR) criteria.
• Patients with an evaluated joint (knee or hip) with a K-L (Kellgren-Lawrence) score of ≥2 based on the X-ray test performed.
• Moderate to severe pain in the evaluated joint, defined as a WOMAC pain score of ≥4 (mean of the 5 items), on the WOMAC assessments.
• Patients who satisfy both 1) and 2) below.
• Inadequate OA pain relief from at least 1 oral NSAID.
• Intolerance to or inadequate OA pain relief from at least 1 opioid (including combination drugs), or unwillingness to take opioid therapy.
• Patients who agree to not change their current lifestyle (daily living activities and exercise) throughout the study.
• Patients who are able to complete post-operative follow-up for any joint replacement surgery that is performed during the study.
• Body mass index at screening ≤39.
• Patient who are able to understand and answer endpoint questions used in the study.

You may not qualify if:

• Additional screening criteria check may apply for qualification:
• Presence of symptoms of carpal tunnel syndrome within 6 months before screening.
• Patients who cannot undergo MRI.
• Trauma to the index joint within 3 months prior to screening.
• Presence or history of inflammatory joint diseases other than OA, Paget's disease of the spine, pelvis or femur, multiple sclerosis, fibromyalgia, vertebral tumors or infections, or renal osteodystrophy.
• Presence or history, confirmed by imaging, of arthropathy, neuropathic joint arthropathy, hip dislocation, knee dislocation, extensive subchondral cyst, marked bone destruction or bone loss, or pathologic fractures.
• Autonomic neuropathy diagnosed in the assessment of autonomic nerve symptoms performed at screening, or baseline.
• Presence or history of orthostatic hypotension at the orthostatic hypotension assessments performed at screening, prerandomization, or baseline.
• Presence or history of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy such as reflex sympathetic dystrophy at screening.
• Presence or history of chronic familial dysautonomia.
• Intolerance to naproxen.
• Systemic (excluding topical, intranasal, ophthalmic, and inhaled formulations) corticosteroids within 4 weeks prior to screening.
• Intra-articular corticosteroids in the evaluated joint within 12 weeks prior to screening, or in any other joint within 4 weeks prior to screening.
• Received an intra-articular injection of hyaluronic acid in any joint within the period specified for each medicine prior to screening.
• Resting heart rate of \<50 bpm or \>100 bpm at screening, or baseline.

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (27)

Investigational Site

Aichi, Japan

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Investigational Site

Aomori, Japan

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Chiba, Japan

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Ehime, Japan

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Fukui, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Kagoshima, Japan

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Kanagawa, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mie, Japan

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Miyagi, Japan

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Miyazaki, Japan

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Osaka, Japan

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Ōita, Japan

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Saitama, Japan

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Shiga, Japan

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Shizuoka, Japan

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Tokyo, Japan

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Yamagata, Japan

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Yamaguchi, Japan

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

fasinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Please email

Study Officials

• General Manager

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: August 7, 2017
• First Posted: August 10, 2017
• Study Start: September 8, 2017
• Primary Completion: December 14, 2019
• Study Completion: March 9, 2021
• Last Updated: January 7, 2026
• Results First Posted: May 17, 2023

Record last verified: 2025-12

Locations

JP (27)