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Trial record 3 of 4 for:    ubx0101

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

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ClinicalTrials.gov Identifier: NCT04129944
Recruitment Status : Completed
First Posted : October 17, 2019
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE October 15, 2019
First Posted Date  ICMJE October 17, 2019
Last Update Posted Date June 23, 2021
Actual Study Start Date  ICMJE October 30, 2019
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
Change from baseline to Week 12 of the WOMAC-A score in patients receiving a single dose of UBX0101 versus those receiving placebo [ Time Frame: Baseline to Week 12 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2019)
  • 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
  • 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 ]
    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
  • 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 ]
  • Incidence of AEs as well as change from baseline through Weeks 12 and 24 in vital signs and selected laboratory safety parameters (as deemed clinically appropriate) in patients receiving a single dose of UBX0101 versus those receiving placebo [ Time Frame: Baseline to Week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 15, 2019)
  • Change from baseline to Week 12 of the WOMAC-C function subscale score in patients receiving a single dose of UBX0101 versus those receiving placebo [ Time Frame: Baseline to Week 12 ]
  • Change from baseline to Week 12 of the weekly mean of the average daily pain intensity scores on the 11-point NRS in patients receiving a single dose of UBX0101 versus those receiving placebo [ Time Frame: 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 [ Time Frame: Baseline to Week 24 ]
  • Incidence of AEs as well as change from baseline through Weeks 12 and 24 in vital signs and selected laboratory safety parameters (as deemed clinically appropriate) in patients receiving a single dose of UBX0101 versus those receiving placebo [ Time Frame: Baseline to Week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Efficacy of a Single Dose of UBX0101 in Patients With Osteoarthritis of the Knee
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: UBX0101
    Investigational drug intra-articular injection
  • Other: Placebo
    Placebo intra-articular injection
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: UBX0101 0.5 mg
    Intervention: Drug: UBX0101
  • Experimental: UBX0101 2.0 mg
    Intervention: Drug: UBX0101
  • Experimental: UBX0101 4.0 mg
    Intervention: Drug: UBX0101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2020)
183
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2019)
180
Actual Study Completion Date  ICMJE August 7, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04129944
Other Study ID Numbers  ICMJE UBX0101-MUS-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Unity Biotechnology, Inc.
Study Sponsor  ICMJE Unity Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor UNITY Biotechnology
PRS Account Unity Biotechnology, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP