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New injection could ease arthritis pain

NCT ID NCT03245008

Symptom relief Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called MT-5547 (fasinumab) in 626 Japanese adults with moderate to severe osteoarthritis pain in the knee or hip. Participants received either the drug or a placebo injection for 16 weeks. The goal was to see if the drug reduces pain and improves daily function better than a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MT-5547 (fasinumab) injection
What this could lead to
If successful, this could provide a new treatment option for people with osteoarthritis who have moderate to severe pain.
What could go wrong
This is an early-to-mid-stage trial, so results may not confirm long-term safety or effectiveness. The drug may cause side effects or not work better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

626 people

The number who actually took part.

Started

Sep 2017

Finished

Mar 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. 1. Inadequate OA pain relief from at least 1 oral NSAID. 2. 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. Exclusion Criteria: 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. * Presence or history of 2nd or 3rd degree heart block, 1st degree heart block with abnormal QRS, or bifascicular block by ECG assessment at screening. * Non-compliance with the Numerical rating scale (NRS) recording (average pain on walking in the evaluated joint over 1 day) during the pre-treatment observation period. * Women who are pregnant, breast-feeding, or may be pregnant. * Use of an anti-Nerve growth factor (anti-NGF) antibody in the past, or apparent hypersensitivity or intolerance to anti-NGF antibodies.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, hip osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteoarthritis, knee / osteoarthritis, hip

Contacts and locations

Locations

  • Investigational Site

    Aichi, Japan

  • Investigational Site

    Aomori, Japan

  • Investigational Site

    Chiba, Japan

  • Investigational Site

    Ehime, Japan

  • Investigational Site

    Fukui, Japan

  • Investigational Site

    Fukuoka, Japan

  • Investigational Site

    Fukushima, Japan

  • Investigational Site

    Gunma, Japan

  • Investigational Site

    Hiroshima, Japan

  • Investigational Site

    Hokkaido, Japan

  • Investigational Site

    Hyōgo, Japan

  • Investigational Site

    Ibaraki, Japan

  • Investigational Site

    Kagoshima, Japan

  • Investigational Site

    Kanagawa, Japan

  • Investigational Site

    Kumamoto, Japan

  • Investigational Site

    Kyoto, Japan

  • Investigational Site

    Mie, Japan

  • Investigational Site

    Miyagi, Japan

  • Investigational Site

    Miyazaki, Japan

  • Investigational Site

    Osaka, Japan

  • Investigational Site

    Ōita, Japan

  • Investigational Site

    Saitama, Japan

  • Investigational Site

    Shiga, Japan

  • Investigational Site

    Shizuoka, Japan

  • Investigational Site

    Tokyo, Japan

  • Investigational Site

    Yamagata, Japan

  • Investigational Site

    Yamaguchi, Japan

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