A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients

A Phase 2 study testing MIV-711 in people with Osteoarthritis, Knee, run by Medivir at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA). Read more about this study

Who is it for?: Ages 40 to 81 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: MIV-711
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 4 sitesin 4 countries
Study dates: Sep 2016to 28 Nov 2017
Phase: Phase 2
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 81 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by
Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

Who cannot join

The presence of any inflammatory arthritis
Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

Bulgaria1 site

MC Comac Medical
Sofia

Other trials in Bulgaria

Georgia1 site

LCC ARENSIA Exploratory Medicine
Tbilisi

Other trials in Georgia

Germany1 site

PAREXEL Berlin Early Phase Clinical Unit
Berlin

Other trials in Germany

Moldova1 site

LCC ARENSIA Exploratory Medicine
Chisinau

Other trials in Moldova

About this study

Official title: An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Conditions: Osteoarthritis, Knee
Being tested: MIV-711
Medical subject headings: Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MIV-711Drug
MIV-711 administered orally once daily

Study groups in NCT03037489
Study group	Role	What they receive
MIV-711	Experimental	MIV-711 for a total of 26 weeks Receives: Drug: MIV-711

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)
2. Number of Participants with Serious Adverse Events (SAEs)
3. Number of Participants with TEAEs related to treatment
4. Number of Participants with mild TEAEs
5. Number of Participants with moderate TEAEs
6. Number of Participants with severe TEAEs
7. Number of Participants with TEAEs leading to early discontinuation
Measured: Group A: 0-56 weeks; Group B: 0-30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201628 Nov 2017

First posted31 Jan 2017 (estimated)
Study startSep 2016
Primary completion28 Nov 2017
Study completion28 Nov 2017

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, KneeStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03037489
Sponsor's protocol ID: MIV-711-202
Status last verified: Mar 2019
First submitted: 22 Dec 2016
Last updated: 18 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, One-Arm Phase II Extension Study to Evaluate Safety and Tolerability of MIV-711 in Patients With Knee Joint Osteoarthritis
ClinicalTrials.gov ID: NCT03037489
Acronym / sponsor ID: MIV-711-202
Conditions: Osteoarthritis, Knee
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: MedivirIndustry (pharma, biotech, devices)
Study start: Sep 2016 (actual)
Primary completion: 28 Nov 2017 (actual)
Study completion: 28 Nov 2017 (actual)
First posted: 31 Jan 2017 (estimated)
Results: Posted 18 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a multicentre, open-label, one-arm Phase II extension study to evaluate the safety and tolerability of MIV-711 in patients with knee joint osteoarthritis (OA).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MIV-711	Experimental	Drug: MIV-711MIV-711 for a total of 26 weeks

Who may qualify

Ages: 40 to 81 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Previously enrolled in the MIV-711-201 study including completion of Visit 8 either by
Receiving MIV-711 200 mg and had non-significant clinical worsening on the primary endpoint as defined by a Numeric Rating Scale (NRS) increase of ≤2 OR by
Receiving placebo and had a clinically significant worsening on the primary endpoint as defined by a NRS increase of ≥2

Key exclusion criteria (4 listed)

The presence of any inflammatory arthritis
Any generalized pain condition that may interfere with the evaluation of the target knee pain (e.g., fibromyalgia) as judged by the investigator.
Any clinically severe or significant uncontrolled concurrent illness, which, in the opinion of the Investigator, would impair ability to give informed consent or take part in or complete this clinical study.
Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

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
MIV-711MIV-711 administered orally once daily	Drug	MIV-711

Primary outcome

Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Time frame: Group A: 0-56 weeks; Group B: 0-30 weeks
1. Number of Participants with Treatment Emergent Adverse Events (TEAEs) 2. Number of Participants with Serious Adverse Events (SAEs) 3. Number of Participants with TEAEs related to treatment 4. Number of Participants with mild TEAEs 5. Number of Participants with moderate TEAEs 6. Number of Participants with severe TEAEs 7. Number of Participants with TEAEs leading to early discontinuation

Results and safety

Results posted to the registry on 18 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A	46	39
Group B	4	4

Primary outcome: Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients

Time frame: Group A: 0-56 weeks; Group B: 0-30 weeks. Count of participants. Unit: Participants

Measure	Group A n = 46	Group B n = 4
TEAEs	21	2
SAEs	2	0
Related TEAEs	1	0
Mild TEAEs	6	1
Moderate TEAEs	14	1
Severe TEAEs	1	0
TEAEs leading to early discontinuation	4	0

Adverse events

Time frame: Adverse events were collected from signing the Informed Consent Form to the Follow up visit (4 weeks after end of treatment), up to 56 weeks.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A	2 of 46 (4.3%)	13 of 46 (28.3%)	0 of 46
Group B	0 of 4 (0%)	2 of 4 (50%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis, Knee

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis

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.

Philip Conaghan, Professor principal investigator

Leeds Institute of Rheumatic and Musculoskeletal Medicine

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MIV-711 in people with Osteoarthritis, Knee, run by Medivir at 4 sites in 4 countries.

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 3 inclusion and 4 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 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Bulgaria, Georgia, Germany, Moldova. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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 18 Mar 2019). 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?

Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients (time frame: Group A: 0-56 weeks; Group B: 0-30 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03037489.

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 18 Mar 2019.