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

NCT04129944 | Completed Phase 2 Results FDA Drug

• 1 other identifier: UBX0101-MUS-201
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 20

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).

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Pain Subscale (WOMAC-A) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo

  WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain

  Baseline to Week 12

Secondary Outcomes (4)

• Change From Baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index Function Subscale (WOMAC-C) Score in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo

  Baseline to Week 12

• Change From Baseline to Week 12 of the Weekly Mean of the Average Daily Pain (ADP) Intensity Scores on the 11-point Numeric Rating Scale (NRS) in Patients Receiving a Single Dose of UBX0101 Versus Those Receiving Placebo

  Baseline to Week 12

• Change From Baseline (Over the Entire 24-week Period, Including Both the Primary Study Period and the 12-week Follow-up Period) to Week 24 for the WOMAC-A, NRS, and WOMAC-C Scores in Patients Receiving a Dose of UBX0101 Versus Those Receiving Placebo

  Baseline to Week 24

• Incidence of Treatment Emergent Adverse Events (TEAEs)

  Baseline to Week 24

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Other: Placebo

UBX0101 0.5 mg

EXPERIMENTAL

Drug: UBX0101

UBX0101 2.0 mg

EXPERIMENTAL

Drug: UBX0101

UBX0101 4.0 mg

EXPERIMENTAL

Drug: UBX0101

Interventions

UBX0101 DRUG

Investigational drug intra-articular injection

UBX0101 0.5 mg; UBX0101 2.0 mg; UBX0101 4.0 mg

Placebo OTHER

Placebo intra-articular injection

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Biotechnology, Inc.: lead

Study Sites (20)

Central Research Associates

Birmingham, Alabama, 35205, United States

Location

Coastal Clinical Research, LLC.

Mobile, Alabama, 36608, United States

Location

Fiel Family and Sports Medicine

Tempe, Arizona, 85283, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

Biosolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Charter Research

Lady Lake, Florida, 32159, United States

Location

Well-Pharma Medical Research

Miami, Florida, 33143, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Premier Medical Associates

The Villages, Florida, 32159, United States

Location

Chicago Clinical Research Institute

Chicago, Illinois, 60607, United States

Location

The Alliance for Multispecialty Research

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research-Lexington

Lexington, Kentucky, 40509, United States

Location

The Alliance for Multispecialty Research

Kansas City, Missouri, 64114, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Albuquerque Clinical Trials

Albuquerque, New Mexico, 87102, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Rochester Clinical Research

Rochester, New York, 14609, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29406, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Unity Biotechnology, Inc.

Clinicaltrials@unitybiotechnology.com

650-416-1192

Study Officials

• Medical Monitor

  UNITY Biotechnology

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 17, 2019
• Study Start: October 30, 2019
• Primary Completion: May 20, 2020
• Study Completion: August 7, 2020
• Last Updated: December 29, 2021
• Results First Posted: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)