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

• ClinicalTrials.gov Identifier: NCT03037489
• Recruitment Status: Completed
• First Posted: January 31, 2017
• Results First Posted: March 18, 2019
• Last Update Posted: March 18, 2019
• Sponsor: Medivir
• Information provided by (Responsible Party): Medivir

Tracking Information

• First Submitted Date: December 22, 2016
• First Posted Date: January 31, 2017
• Results First Submitted Date: November 26, 2018
• Results First Posted Date: March 18, 2019
• Last Update Posted Date: March 18, 2019
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: November 28, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2019)

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

Original Primary Outcome Measures (submitted: January 26, 2017)

Safety and tolerability of MIV-711 in OA patients [ Time Frame: 26 weeks ]

1. AE/SAE
   1. measuring the number of AEs
   2. summarizing the severities of AEs
   3. measuring the number of AEs related to treatment
   4. summarizing the severities of AEs related to treatment
   5. measuring the number and severity of SAEs
   6. measuring the number and severity of SAEs related to treatment
2. Labs
   1. Number of abnormals
   2. Number of grade 3 or 4 (if grading lab results)
   3. Change from baseline
3. ECGS
   1. Number of abnormals
   2. Change from baseline
   3. Number of pts with prolonged QTc
   4. Etc
4. PE
   1. Number of abnormals
   2. Change from baseline
5. Vitals
   1. BP
   2. Heart rate

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients
• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis, Knee

Intervention

Drug: MIV-711

MIV-711 administered orally once daily

Study Arms

Experimental: MIV-711

MIV-711 for a total of 26 weeks

Intervention: Drug: MIV-711

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 24, 2017): 50
• Original Estimated Enrollment (submitted: January 26, 2017): 80
• Actual Study Completion Date: November 28, 2017
• Actual Primary Completion Date: November 28, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years to 81 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria, Georgia, Germany, Moldova, Republic of

Administrative Information

• NCT Number: NCT03037489
• Other Study ID Numbers: MIV-711-202
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Medivir
• Study Sponsor: Medivir
• Collaborators: Not Provided

Investigators

• Principal Investigator: Philip Conaghan, Professor; Leeds Institute of Rheumatic and Musculoskeletal Medicine

• PRS Account: Medivir
• Verification Date: March 2019