- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04129944
A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Central Research Associates
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Mobile, Alabama, United States, 36608
- Coastal Clinical Research, LLC.
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Arizona
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Tempe, Arizona, United States, 85283
- Fiel Family and Sports Medicine
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Tucson, Arizona, United States, 85712
- Tucson Orthopaedic Institute
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California
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La Mesa, California, United States, 91942
- Biosolutions Clinical Research Center
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Walnut Creek, California, United States, 94598
- Diablo Clinical Research
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Florida
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Lady Lake, Florida, United States, 32159
- Charter Research
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Miami, Florida, United States, 33143
- Well-Pharma Medical Research
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Sunrise, Florida, United States, 33351
- Precision Clinical Research
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The Villages, Florida, United States, 32159
- Premier Medical Associates
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Illinois
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Chicago, Illinois, United States, 60607
- Chicago Clinical Research Institute
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Kansas
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Wichita, Kansas, United States, 67207
- The Alliance for Multispecialty Research
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Kentucky
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Lexington, Kentucky, United States, 40509
- Alliance for Multispecialty Research-Lexington
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Missouri
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Kansas City, Missouri, United States, 64114
- The Alliance for Multispecialty Research
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New Jersey
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Berlin, New Jersey, United States, 08009
- Hassman Research Institute
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- Albuquerque Clinical Trials
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New York
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Hartsdale, New York, United States, 10530
- Drug Trials America
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Rochester, New York, United States, 14609
- Rochester Clinical Research
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Pennsylvania
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Duncansville, Pennsylvania, United States, 16635
- Altoona Center For Clinical Research
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South Carolina
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North Charleston, South Carolina, United States, 29406
- Coastal Carolina Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key 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.
Key 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Placebo
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Placebo intra-articular injection
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Experimental: UBX0101 0.5 mg
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Investigational drug intra-articular injection
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Experimental: UBX0101 2.0 mg
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Investigational drug intra-articular injection
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Experimental: UBX0101 4.0 mg
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Investigational drug intra-articular injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline to Week 12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: Baseline to Week 12
|
WOMAC-C is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of physical disability
|
Baseline to Week 12
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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
Time Frame: Baseline to Week 12
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ADP is assessed by NRS on a range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating higher levels of pain
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Baseline to Week 12
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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
Time Frame: Baseline to Week 24
|
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 WOMAC-C is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of physical disability. Average Daily Pain (ADP) is assessed by Numerical Rating Score (NRS) on a range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating higher levels of pain. |
Baseline to Week 24
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Incidence of Treatment Emergent Adverse Events (TEAEs)
Time Frame: Baseline to Week 24
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Baseline to Week 24
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBX0101-MUS-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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