A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee

NCT ID: NCT04129944

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2020-08-07

Brief Summary

A study to assess efficacy, safety, and tolerability of a single-dose intra-articular administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).

Detailed Description

This is a randomized, double-blind, placebo-controlled, single-dose, parallel-group study to assess the efficacy, safety, and tolerability of a single-dose intra-articular (IA) administration of UBX0101 in patients with moderate to severe painful knee osteoarthritis (OA).

Approximately 180 patients will be randomized (1:1:1:1) to one of four treatment groups (three dose levels of UBX0101 and Placebo; approximately 45 patients per group), all administered by IA route at Week 0. The four treatment groups will be enrolled concurrently.

The primary objective of the study is to evaluate the effect of IA administration of UBX0101 on the change from baseline to Week 12 of pain in the target knee.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo intra-articular injection

UBX0101 0.5 mg

Group Type: EXPERIMENTAL

UBX0101

Intervention Type: DRUG

Investigational drug intra-articular injection

UBX0101 2.0 mg

Group Type: EXPERIMENTAL

UBX0101

Intervention Type: DRUG

Investigational drug intra-articular injection

UBX0101 4.0 mg

Group Type: EXPERIMENTAL

UBX0101

Intervention Type: DRUG

Investigational drug intra-articular injection

Interventions

UBX0101

Investigational drug intra-articular injection

Intervention Type: DRUG

Placebo

Placebo intra-articular injection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients who are ambulatory with a diagnosis of OA of the knee and who have baseline pain with a mean of ≥ 4 and ≤ 9 on the 11-point (0-10) average daily pain NRS for at least five of seven days during the Screening period.
• Kellgren-Lawrence grade of 1-4 on a weight-bearing radiograph of target knee.
• Patients aged ≥ 40 and ≤ 85 years.
• Patients are permitted but not required to use an oral NSAID, serotonin and norepinephrine reuptake inhibitors (SNRIs), tramadol, or acetaminophen, provided that they have been taking a stable dose and regimen of medication for at least 4 weeks prior to Screening.

Exclusion Criteria

• Patients with any condition, including laboratory or imaging findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator or the Medical Monitor constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study.
• Patients with a body mass index (BMI) ≥40 kg/m2 or a body habitus that precludes the MRI.
• Patients with fibromyalgia
• Systemic autoimmune disease with musculoskeletal involvement or any history of a systemic inflammatory arthritis
• Patients who have received IA treatment in the target knee with steroids or hyaluronic acid derivatives within the last 16 weeks prior to Screening, or with extended-release corticosteroid (e.g., Zilretta®) within the last 20 weeks
• Patients who are using a topical NSAID or topical analgesics on the target knee.
• Patients who have used opioid analgesics (other than tramadol), marijuana or marijuana-derived products (e.g., cannabidiol), and topical capsaicin on the target knee within 8 weeks prior to Screening
• Patients with a history of traumatic knee injury to the target knee, including, but not limited to, patients with meniscal root tear, within 2 years of study entry.
• Patients who have undergone diagnostic arthroscopy to the target knee in the previous 6 months.
• Patients who have undergone arthroscopic surgery (including microfracture and meniscectomy) on the target knee in the last 2 years prior to the Screening visit or are anticipated to have arthroscopic surgery on either knee at any time during the study period.
• Patients with a history of previous total or partial knee arthroplasty.
• Patients with an effusion at the Screening visit, which, in the opinion of the Investigator following examination and discussions with the patient, requires drainage for symptom relief.
• Patients who have had regenerative joint procedures on any joint, including, but not limited to, platelet-rich plasma injections, stem cell transplantation, autologous chondrocyte transplantation, or mosaicplasty.
• Patients with secondary arthritis that involves the target knee or would confound assessments of knee OA

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

UNITY Biotechnology

Locations

Central Research Associates

Birmingham, Alabama, United States

Coastal Clinical Research, LLC.

Mobile, Alabama, United States

Fiel Family and Sports Medicine

Tempe, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

Biosolutions Clinical Research Center

La Mesa, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Charter Research

Lady Lake, Florida, United States

Well-Pharma Medical Research

Miami, Florida, United States

Precision Clinical Research

Sunrise, Florida, United States

Premier Medical Associates

The Villages, Florida, United States

Chicago Clinical Research Institute

Chicago, Illinois, United States

The Alliance for Multispecialty Research

Wichita, Kansas, United States

Alliance for Multispecialty Research-Lexington

Lexington, Kentucky, United States

The Alliance for Multispecialty Research

Kansas City, Missouri, United States

Hassman Research Institute

Berlin, New Jersey, United States

Albuquerque Clinical Trials

Albuquerque, New Mexico, United States

Drug Trials America

Hartsdale, New York, United States

Rochester Clinical Research

Rochester, New York, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UBX0101-MUS-201

Identifier Type: -

Identifier Source: org_study_id