Osteoarthritis, Knee
Conditions
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).
Interventions
DRUGMIV-711
MIV-711 administered orally once daily
Sponsors
Medivir
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 81 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | 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 |
Countries
Bulgaria, Georgia, Germany, Moldova
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 and whose symptoms did not clinically significantly deteriorate as defined by an increase in the NRS of ≤2 compared to baseline. Patients in Study Group A continued the same dosing with 200 mg MIV-711 once daily for 26 additional weeks. | 46 |
| Group B Study Group B was recruited from patients receiving placebo in Study MIV-711-201 having experienced a clinical worsening as defined by an increase in NRS of ≥2 versus baseline. Patients in Study Group B were treated with 200 mg MIV-711 once daily for the next 26 weeks. | 4 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Group B | Group A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 16 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 30 Participants | 32 Participants |
| Age, Continuous | 65.5 years STANDARD_DEVIATION 5.51 | 61.5 years STANDARD_DEVIATION 7.52 | 61.8 years STANDARD_DEVIATION 7.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 46 Participants | 50 Participants |
| Region of Enrollment Bulgaria | 0 participants | 9 participants | 9 participants |
| Region of Enrollment Georgia | 0 participants | 3 participants | 3 participants |
| Region of Enrollment Germany | 1 participants | 13 participants | 14 participants |
| Region of Enrollment Moldova | 3 participants | 21 participants | 24 participants |
| Sex: Female, Male Female | 3 Participants | 31 Participants | 34 Participants |
| Sex: Female, Male Male | 1 Participants | 15 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 4 |
| other Total, other adverse events | 13 / 46 | 2 / 4 |
| serious Total, serious adverse events | 2 / 46 | 0 / 4 |
Outcome results
Primary
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
Time frame: Group A: 0-56 weeks; Group B: 0-30 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Related TEAEs | 1 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Moderate TEAEs | 14 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | SAEs | 2 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Severe TEAEs | 1 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Mild TEAEs | 6 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | TEAEs leading to early discontinuation | 4 Participants |
| Group A | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | TEAEs | 21 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | TEAEs leading to early discontinuation | 0 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | TEAEs | 2 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | SAEs | 0 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Related TEAEs | 0 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Mild TEAEs | 1 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Moderate TEAEs | 1 Participants |
| Group B | Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients | Severe TEAEs | 0 Participants |