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

Osteoarthritis, Knee Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04129944
• Other study ID #: UBX0101-MUS-201
• Status: Completed
• Phase: Phase 2
• Start date: October 30, 2019
• Est. completion date: August 7, 2020

Study information

• Verified date: November 2021
• Source: Unity Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: August 7, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• UBX0101
Investigational drug intra-articular injection

Other:
• Placebo
Placebo intra-articular injection

Locations

Country	Name	City	State
United States	Albuquerque Clinical Trials	Albuquerque	New Mexico
United States	Hassman Research Institute	Berlin	New Jersey
United States	Central Research Associates	Birmingham	Alabama
United States	Chicago Clinical Research Institute	Chicago	Illinois
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Drug Trials America	Hartsdale	New York
United States	The Alliance for Multispecialty Research	Kansas City	Missouri
United States	Biosolutions Clinical Research Center	La Mesa	California
United States	Charter Research	Lady Lake	Florida
United States	Alliance for Multispecialty Research-Lexington	Lexington	Kentucky
United States	Well-Pharma Medical Research	Miami	Florida
United States	Coastal Clinical Research, LLC.	Mobile	Alabama
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Rochester Clinical Research	Rochester	New York
United States	Precision Clinical Research	Sunrise	Florida
United States	Fiel Family and Sports Medicine	Tempe	Arizona
United States	Premier Medical Associates	The Villages	Florida
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	Diablo Clinical Research	Walnut Creek	California
United States	The Alliance for Multispecialty Research	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Unity Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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	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	Baseline to Week 12
Secondary	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	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
Secondary	Incidence of Treatment Emergent Adverse Events (TEAEs)		Baseline to Week 24