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

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Osteoarthritis, Knee
• Intervention: Drug: MIV-711
• Enrollment: 50

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Group A	Group B
Arm/Group Description	Study Group A was recruited from patients treated with 200 mg MIV-711 once daily in Study MIV-711-201 (NCT02705625) and whose symptoms did not clinically significantly deteriorate as defined by an increase in the Numeric Rating Scale (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.	Study Group B was recruited from patients receiving placebo in Study MIV-711-201 (NCT02705625) 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.
Period Title: Overall Study
Started	46	4
Completed	39	4
Not Completed	7	0
Reason Not Completed
Adverse Event	4	0
Withdrawal by Subject	3	0

Baseline Characteristics

Arm/Group Title		Group A	Group B	Total
Arm/Group Description		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.	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.	Total of all reporting groups
Overall Number of Baseline Participants		46	4	50
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	4 participants	50 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	30 65.2%	2 50.0%	32 64.0%
	>=65 years	16 34.8%	2 50.0%	18 36.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	46 participants	4 participants	50 participants
		61.5 (7.52)	65.5 (5.51)	61.8 (7.42)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	4 participants	50 participants
	Female	31 67.4%	3 75.0%	34 68.0%
	Male	15 32.6%	1 25.0%	16 32.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	46 participants	4 participants	50 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	46 100.0%	4 100.0%	50 100.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	46 participants	4 participants	50 participants
Moldova		21	3	24
Georgia		3	0	3
Bulgaria		9	0	9
Germany		13	1	14

Outcome Measures

1. Primary Outcome

Title	Safety and Tolerability of MIV-711 in Osteoarthritis (OA) Patients
Description	Number of Participants with Treatment Emergent Adverse Events (TEAEs); Number of Participants with Serious Adverse Events (SAEs); Number of Participants with TEAEs related to treatment; Number of Participants with mild TEAEs; Number of Participants with moderate TEAEs; Number of Participants with severe TEAEs; Number of Participants with TEAEs leading to early discontinuation
Time Frame	Group A: 0-56 weeks; Group B: 0-30 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	46	4
Measure Type: Count of Participants; Unit of Measure: Participants
TEAEs	21 45.7%	2 50.0%
SAEs	2 4.3%	0 0.0%
Related TEAEs	1 2.2%	0 0.0%
Mild TEAEs	6 13.0%	1 25.0%
Moderate TEAEs	14 30.4%	1 25.0%
Severe TEAEs	1 2.2%	0 0.0%
TEAEs leading to early discontinuation	4 8.7%	0 0.0%

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.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Group A		Group B
Arm/Group Description	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.		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.
All-Cause Mortality
	Group A		Group B
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/46 (0.00%)		0/4 (0.00%)
Serious Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/46 (4.35%)		0/4 (0.00%)
Cardiac disorders
Angina pectoris † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Atrial fibrillation † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Cardiac failure † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Ischaemic cardiomyopathy † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Gastrointestinal disorders
Duodenitis † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Gastritis † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Bronchiectasis † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Bronchitis chronic † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Interstitial lung disease † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
Respiratory failure † 1	1/46 (2.17%)	1	0/4 (0.00%)	0
1 Term from vocabulary, MedDRA (18.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	4%
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/46 (28.26%)		2/4 (50.00%)
Gastrointestinal disorders
Chronic gastritis † 1	2/46 (4.35%)	2	0/4 (0.00%)	0
Duodenal ulcer † 1	2/46 (4.35%)	2	0/4 (0.00%)	0
Infections and infestations
Nasopharyngitis † 1	4/46 (8.70%)	4	1/4 (25.00%)	1
Upper respiratory tract infection † 1	2/46 (4.35%)	2	0/4 (0.00%)	0
Musculoskeletal and connective tissue disorders
Joint swelling † 1	2/46 (4.35%)	2	0/4 (0.00%)	0
Nervous system disorders
Headache † 1	1/46 (2.17%)	1	1/4 (25.00%)	1
1 Term from vocabulary, MedDRA (18.1); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Linda Basse, Cheif Medical Officer
• Organization: Medivir AB
• Phone: +46 8 546 831 00
• EMail: linda.basse@medivir.com

• Responsible Party: Medivir
• ClinicalTrials.gov Identifier: NCT03037489
• Other Study ID Numbers: MIV-711-202
• First Submitted: December 22, 2016
• First Posted: January 31, 2017
• Results First Submitted: November 26, 2018
• Results First Posted: March 18, 2019
• Last Update Posted: March 18, 2019