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Trial record 1 of 1 for:    (NCT04229225)
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A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT04229225
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

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).

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: UBX0101 Other: Placebo Phase 1

Detailed Description:

This is a randomized, double-blind, placebo-controlled study conducted as two parallel cohorts to assess the safety, tolerability, and clinical effects of single dose (SD) and repeat dose (RD) intra-articular (IA) administration of UBX0101 in patients with symptomatic knee osteoarthritis (OA).

Approximately 36 patients will be randomly assigned to either Cohort 1 (SD) or Cohort 2 (RD) (18 patients per treatment cohort) and further randomized in a 2:1 ratio to UBX0101 and placebo in each cohort.

The primary objective of the study is to evaluate the safety and tolerability of SD and RD IA administration of UBX0101 over 24 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of Single and Repeat Dose Administration of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee
Actual Study Start Date : January 23, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: UBX0101 single dose (SD)

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
Investigational drug intra-articular (IA) injection

Other: Placebo
Placebo intra-articular (IA) injection

Experimental: UBX0101 repeat dose (RD)

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
Investigational drug intra-articular (IA) injection

Other: Placebo
Placebo intra-articular (IA) injection




Primary Outcome Measures :
  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 [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Plasma UBX0101 drug concentrations following IA administration [ Time Frame: 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 ]
  2. 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 [ 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

  3. Change from baseline to Week 24 of the WOMAC-A score over time in patients receiving 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

  4. 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 [ 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

  5. 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 [ Time Frame: Baseline to Week 12 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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.

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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229225


Contacts
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Contact: Clinical Trials at UNITY 650-416-1192 clinicaltrials@unitybiotechnology.com

Locations
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United States, Florida
Premier Medical Associates Recruiting
The Villages, Florida, United States, 32159
United States, Georgia
Drug Studies America Recruiting
Marietta, Georgia, United States, 30060
United States, Missouri
Sundance Clinical Research, LLC Recruiting
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Rochester Clinical Research, Inc. Recruiting
Rochester, New York, United States, 14609
United States, South Carolina
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine Recruiting
North Charleston, South Carolina, United States, 29406
United States, Texas
First Surgical Hospital Recruiting
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
Unity Biotechnology, Inc.
Investigators
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Study Director: Medical Monitor Unity Biotechnology

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Responsible Party: Unity Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04229225    
Other Study ID Numbers: UBX0101-MUS-102
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Biotechnology, Inc.:
Osteoarthritis
Painful Osteoarthritis
Osteoarthritis, Knee
Senescence
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases