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

NCT03037489 | Completed Phase 2 Results DMC

• 1 other identifier: MIV-711-202
• Study Type: interventional
• Target: 50
• Locations: 4 countries
• Sites: 4

Brief 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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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

  Group A: 0-56 weeks; Group B: 0-30 weeks

Study Arms (1)

MIV-711

EXPERIMENTAL

MIV-711 for a total of 26 weeks

Drug: MIV-711

Interventions

MIV-711 DRUG

MIV-711 administered orally once daily

MIV-711

Eligibility Criteria

• Age: 40 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medivir: lead

Study Sites (4)

MC Comac Medical

Sofia, Bulgaria

Location

LCC ARENSIA Exploratory Medicine

Tbilisi, Georgia

Location

PAREXEL Berlin Early Phase Clinical Unit

Berlin, Germany

Location

LCC ARENSIA Exploratory Medicine

Chisinau, Moldova

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

MIV-711

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Linda Basse, Cheif Medical Officer
• Organization: Medivir AB

linda.basse@medivir.com

+46 8 546 831 00

Study Officials

• Philip Conaghan, Professor

  Leeds Institute of Rheumatic and Musculoskeletal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 31, 2017
• Study Start: September 1, 2016
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: March 18, 2019
• Results First Posted: March 18, 2019

Record last verified: 2019-03

Locations

GE (1); MO (1); BU (1); DE (1)