Osteoarthritis, Knee / Osteoarthritis, HipPhase 2/3NCT03245008
Efficacy and Safety of MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
A Phase 2/3 study testing MT-5547 in people with Osteoarthritis, Knee / Osteoarthritis, Hip, run by Tanabe Pharma Corporation at 27 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee / Osteoarthritis, Hip
- What is being tested?
- MT-5547
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 626 participants
- Where
- 27 sitesJapan
- Study dates
- 8 Sep 2017to 9 Mar 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Japan27 sites
Investigational Site
Aichi
Investigational Site
Aomori
Investigational Site
Chiba
Investigational Site
Ehime
Investigational Site
Fukui
Investigational Site
Fukuoka
Investigational Site
Fukushima
Investigational Site
Gunma
Investigational Site
Hiroshima
Investigational Site
Hokkaido
Investigational Site
Hyōgo
Investigational Site
Ibaraki
Investigational Site
Kagoshima
Investigational Site
Kanagawa
Investigational Site
Kumamoto
Investigational Site
Kyoto
Investigational Site
Mie
Investigational Site
Miyagi
Investigational Site
Miyazaki
Investigational Site
Ōita
Investigational Site
Osaka
Investigational Site
Saitama
Investigational Site
Shiga
Investigational Site
Shizuoka
Investigational Site
Tokyo
Investigational Site
Yamagata
Investigational Site
Yamaguchi
About this study
Official title: A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
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.
Read the detailed description
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.
- Being tested
- MT-5547, MT-5547-matching placebo
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-5547Drug
Also called Fasinumab
Solution for injection in pre-filled syringe
MT-5547-matching placeboDrug
Solution for injection in pre-filled syringe
| Study group | Role | What they receive |
|---|---|---|
| MT-5547 dosing regimen 1 | Experimental | MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16. Receives: Drug: MT-5547 |
| MT-5547 dosing regimen 2 | Experimental | MT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16. Receives: 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. Receives: Drug: MT-5547-matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (8)
WOMAC Physical Function Score (Change From Baseline at Week 16)
The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
Measured: Baseline to Week 16
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)
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.
Measured: Baseline to Week 68
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
The WOMAC physical function subscale score was defined as the average of 17 items(the level of difficulty of activities of daily living: stair use, rising from sitting, standing, bending, walking, getting in and out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, heavy household duties, light household duties). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no difficulty) to 10(extremely difficult), where higher scores indicated worse function limitation.
Measured: Baseline to Week 68
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
The WOMAC stiffness subscale score was defined as the average of 2 items(after first waking and later in the day). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where higher scores indicated worse stiffness.
Measured: Baseline to Week 68
WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
The WOMAC total subscale score was defined as the average of 24 items(5 pain subscale items, 17 physical functioning subscale items, and 2 stiffness subscale items). The participants assessed the past 48 hours on an 11-point numeric rating scale, from 0 (no stiffness) to 10(extremely stiffness), where smaller values being better.
Measured: Baseline to Week 68
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)
Patient Global Assessment(PGA) was a measure whereby the participant assessed global improvement in OA using the 5-level scale(1=very well; 2=well; 3=fair; 4=poor; and 5=very poor).
Measured: Baseline to Week 68
Number of Participants With Adverse Events and Adverse Drug Reactions
Measured: Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
Number of Participants With a Joint Replacement Procedure is Scheduled
All the Joint Replacement surgeries that were performed within 20 weeks from the day after the end date of the treatment period were reported and tabulated in this study in order to assess the outcome of joint damage regardless of the presence or absence of related adjudicated arthropathy. The subjects who were going to undergo JR surgery were to be withdrawn from study treatment.
Measured: Baseline to Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start8 Sep 2017
- Primary completion14 Dec 2019
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, Knee / Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245008
- Sponsor's protocol ID
- MT-5547-J01
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2017
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 (Placebo-Controlled, Double-Blind, Comparative) Study on MT-5547 in Patients With Osteoarthritis Accompanied by Moderate to Severe Pain
- ClinicalTrials.gov ID
- NCT03245008
- Acronym / sponsor ID
- MT-5547-J01
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Posted 17 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The blind will be maintained, including for the study sponsor, until the key code is opened after the data have been fixed for all subjects in Week 24. In addition, in order to eliminate any bias that could affect the study assessments, to the extent possible, the blind will be maintained with respect to the study site and the subject even after the opening of the study sponsor key code.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-5547 dosing regimen 1 | Experimental | Drug: MT-5547MT-5547 Subcutaneous (SC) dosing regimen 1. Naproxen-matching placebo oral after Week 16. |
| MT-5547 dosing regimen 2 | Experimental | Drug: MT-5547, Drug: MT-5547-matching placeboMT-5547 SC dosing regimen 2. Naproxen-matching placebo oral after Week 16. |
| MT-5547-matching placebo | Placebo comparator | Drug: MT-5547-matching placeboMT-5547-matching placebo SC dosing. Naproxen oral after Week 16. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-5547Also: FasinumabSolution for injection in pre-filled syringe | Drug | MT-5547 dosing regimen 1, MT-5547 dosing regimen 2 |
| MT-5547-matching placeboSolution for injection in pre-filled syringe | Drug | MT-5547 dosing regimen 2, MT-5547-matching placebo |
Primary outcome
WOMAC Pain Score (Change From Baseline at Week 16)
Time frame: Baseline to 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.
8 secondary outcomes
WOMAC Physical Function Score (Change From Baseline at Week 16)
Time frame: Baseline to Week 16
WOMAC Pain Score (Change From Baseline at Each Assessment Time Point)
Time frame: Baseline to Week 68
WOMAC Physical Function Score (Change From Baseline at Each Assessment Time Point)
Time frame: Baseline to Week 68
WOMAC Stiffness Score (Change From Baseline at Each Assessment Time Point)
Time frame: Baseline to Week 68
WOMAC Total Score (Change From Baseline at Each Assessment Time Point)
Time frame: Baseline to Week 68
Patient Global Assessment (PGA) (Change From Baseline at Each Assessment Time Point)
Time frame: Baseline to Week 68
Number of Participants With Adverse Events and Adverse Drug Reactions
Time frame: Baseline to Week 68 (Treatment period=48 weeks, Post-treatment Observation Period=20weeks)
Number of Participants With a Joint Replacement Procedure is Scheduled
Time frame: Baseline to Week 68
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MT-5547 in people with Osteoarthritis, Knee / Osteoarthritis, Hip, run by Tanabe Pharma Corporation at 27 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC Pain Score (Change From Baseline at Week 16) (time frame: Baseline to Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.