A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee

NCT04229225 | Completed Phase 1 FDA Drug

• 1 other identifier: UBX0101-MUS-102
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a single and repeat dose intra-articular administration of UBX0101 evaluated by the incidence of serious and non-serious adverse events

  Baseline to Week 24

Secondary Outcomes (5)

• Plasma UBX0101 drug concentrations following IA administration

  1, 2, and 4 hours post-dose for both cohorts on Day 1 and at 1, 2, and 4 hours post-dose at Week 4 for Cohort 2 only

• Change from baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index pain subscale (WOMAC-A) score in patients receiving UBX0101 versus those receiving placebo

  Baseline to Week 12

• Change from baseline to Week 24 of the WOMAC-A score over time in patients receiving UBX0101 versus those receiving placebo

  Baseline to Week 24

• Change from baseline to Week 12 of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale (WOMAC-C) score in patients receiving 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 UBX0101 versus those receiving placebo

  Baseline to Week 12

Study Arms (2)

UBX0101 single dose (SD)

EXPERIMENTAL

Cohort 1 (n=18): UBX0101 8.0 mg or placebo IA at Week 0 Patients will be randomized in a 2:1 ratio to UBX0101 and placebo

Drug: UBX0101; Other: Placebo

UBX0101 repeat dose (RD)

EXPERIMENTAL

Cohort 2 (n=18): UBX0101 4.0 mg or placebo IA at Weeks 0 and 4 Patients will be randomized in a 2:1 ratio to UBX0101 and placebo

Drug: UBX0101; Other: Placebo

Interventions

UBX0101 DRUG

Investigational drug intra-articular (IA) injection

UBX0101 repeat dose (RD); UBX0101 single dose (SD)

Placebo OTHER

Placebo intra-articular (IA) injection

UBX0101 repeat dose (RD); UBX0101 single dose (SD)

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 moderate to severe knee pain as measured on the 11-point (0-10) average daily pain NRS.
• 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.
• 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 in the target knee.
• 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 (7)

Premier Medical Associates

The Villages, Florida, 32159, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine

North Charleston, South Carolina, 29406, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Medical Monitor

  Unity Biotechnology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: January 9, 2020
• First Posted: January 18, 2020
• Study Start: January 23, 2020
• Primary Completion: September 18, 2020
• Study Completion: September 18, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-04

Locations

US (7)