Long-Term Follow-Up Study of Patients With Osteoarthritis of the Knee Treated With UBX0101 or Placebo

Sponsor

Unity Biotechnology, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT04349956

Collaborator

(none)

161

Enrollment

Locations

6.4

Actual Duration (Months)

9.5

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A follow-up study to assess the long-term safety of intra-articular (IA) administration of UBX0101 in patients with painful knee osteoarthritis (OA).

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: UBX0101 or placebo

Detailed Description

This is a blinded, multi-center study to provide approximately 1 additional year of follow-up for patients with knee OA who participated in a randomized placebo-controlled study of IA UBX0101. No intervention is planned and patients will have 4 scheduled visits to collect follow-up assessments. The primary objective is to evaluate long-term safety and tolerability of IA administration of UBX0101 in patients with painful knee OA.

Study Design

Study Type:

Observational

Actual Enrollment :

161 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Long-Term Follow-Up Study of Patients With Moderate to Severe, Painful Osteoarthritis of the Knee Who Participated in a Randomized, Placebo-Controlled Study of UBX0101

Actual Study Start Date :

Apr 20, 2020

Actual Primary Completion Date :

Nov 2, 2020

Actual Study Completion Date :

Nov 2, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients from a randomized placebo-controlled study of UBX0101 Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.	Drug: UBX0101 or placebo This is an observational study. No intervention is administered.

Arm

Intervention/Treatment

Patients from a randomized placebo-controlled study of UBX0101

Patients with moderate to severe, painful OA of the knee who participated in a randomized, placebo-controlled study of UBX0101.

Drug: UBX0101 or placebo

This is an observational study. No intervention is administered.

Outcome Measures

Primary Outcome Measures

Incidence of adverse events up to 1 additional year of follow up. [52 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with knee OA who have completed a randomized placebo-controlled study of UBX0101.
Patients who are willing and able to consent to having blinded, long-term follow-up; consent via legally authorized representative is not accepted.

Exclusion Criteria:

Patients with any condition that, in the opinion of the Investigator, would likely interfere with adhering to the study schedule of visits for 12 months.
Patients who are scheduled to undergo knee arthroplasty on either knee during the study.
Patients who anticipate arthroscopic surgery on either knee at any time during the study.
Patients who plan to receive treatment with an anti-nerve growth factor agent during the study.
Patients who plan to participate in another investigational study (including interventional studies of investigational drugs and investigational treatments [e.g., braces, stem cells, and procedures]) during the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Clinical Research, LLC.	Mobile	Alabama	United States	36608
2	Fiel Family and Sports Medicine	Tempe	Arizona	United States	85283
3	Tucson Orthopaedic Institute	Tucson	Arizona	United States	85712
4	Biosolutions Clinical Research Center	La Mesa	California	United States	91942
5	Diablo Clinical Research	Walnut Creek	California	United States	94598
6	Well-Pharma Medical Research	Miami	Florida	United States	33143
7	Precision Clinical Research	Sunrise	Florida	United States	33351
8	Premier Medical Associates	The Villages	Florida	United States	32159
9	Chicago Clinical Research Institute	Chicago	Illinois	United States	60607
10	The Alliance for Multispecialty Research	Wichita	Kansas	United States	67207
11	Center for Pharmaceutical Research	Kansas City	Missouri	United States	64114
12	Hassman Research Institute	Berlin	New Jersey	United States	08009
13	Albuquerque Clinical Trials	Albuquerque	New Mexico	United States	87102
14	Drug Trials America	Hartsdale	New York	United States	10530
15	Rochester Clinical Research, Inc.	Rochester	New York	United States	14609
16	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
17	Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine	North Charleston	South Carolina	United States	29406