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A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03513016
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 1, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE May 16, 2018
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2018)
Safety and tolerability of a single intra articular injection of UBX0101 evaluated by the incidence of serious and non-serious adverse events [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
To evaluate the safety and tolerability of a single intra articular injection of UBX0101 evaluated by the incidence of serious and non-serious adverse events [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT03513016 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Part A: Plasma concentration of UBX0101 over 24 hrs following a single intra-articular injection [ Time Frame: 24 hrs ]
  • Part A: The change from baseline to Week 12 of the weekly mean of the average daily pain intensity score as obtained using the 11-point numerical rating scale [0-10] where 0 represents no pain and 10 represents worst pain imaginable [ Time Frame: Baseline to Week 12 ]
  • Part A: The change from baseline to Week 12 for the Western Ontario and McMaster Universities (WOMAC) index total score and the pain and function subscales using the 5-point Likert scale [ Time Frame: Baseline to Week 12 ]
  • Part B: The change from baseline to Week 4 of selected senescence-associated secretory phenotype factors in plasma samples and in synovial fluid aspirates in patients receiving a single intra-articular injection of UBX0101 versus those receiving placebo. [ Time Frame: Baseline to Week 4 ]
  • Part B: The change from baseline to Week 4 for the Western Ontario and McMaster Universities (WOMAC) index pain subscale using as derived from Knee injury and Osteoarthritis Outcome Score (KOOS). [ Time Frame: Baseline to Week 4 ]
  • Part B: Plasma concentration of UBX0101 following a single intra-articular injection [ Time Frame: 24 hrs ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • To characterize the plasma concentration of UBX0101 over 24 hrs following a single intra-articular injection [ Time Frame: 24 hrs ]
  • To assess change from baseline to week 12 of the mean weekly, average daily pain intensity score [ Time Frame: 12 weeks ]
  • To assess change from baseline to week 12 in Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index pain score [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee
Official Title  ICMJE A Phase 1, Double-Blind, Randomized, Placebo Controlled, Single Ascending Dose Study to Assess the Safety and Tolerability of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee
Brief Summary A study to evaluate safety, tolerability, and pharmacokinetics of a single intra-articular injection of UBX0101 in patients diagnosed with painful osteoarthritis of the knee.
Detailed Description

This study is a phase 1, randomized, double-blind, placebo-controlled single ascending dose study that will evaluate safety, tolerability, and pharmacokinetics of UBX0101 in patients diagnosed with painful femoro-tibial osteoarthritis. The study consists of 2 parts: Part A is a single ascending dose study, whereas Part B is a single-dose study at a dose that has been determined to be safe and tolerable in Part A of the study.

In Part A, subjects will be randomly allocated to receive UBX0101 or placebo in 3:1 randomization by dose level (cohort), whereas in Part B subjects will be randomly allocated to receive UBX0101 or placebo in a 2:1 randomization.

The primary objective is to establish the safety and tolerability of UBX0101 given as a single intra-articular injection into the femoro-tibial joint of patients with osteoarthritis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE
  • Drug: UBX0101
    Investigational drug intra-articular injection
  • Other: Placebo
    Diluent intra-articular injection
Study Arms  ICMJE
  • Experimental: Part A: UBX0101
    Part A: UBX0101, single intra-articular injection, ascending dose
    Intervention: Drug: UBX0101
  • Placebo Comparator: Part A: Placebo
    Part A: Placebo, single intra-articular injection, ascending dose
    Intervention: Other: Placebo
  • Experimental: Part B: UBX0101
    Part B: UBX0101, single intra-articular injection, fixed dose
    Intervention: Drug: UBX0101
  • Placebo Comparator: Part B: Placebo
    Part B: Placebo, single intra-articular injection, fixed dose
    Intervention: Other: Placebo
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: April 26, 2019)
78
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
40
Actual Study Completion Date  ICMJE April 12, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have the capacity to give informed consent and who are willing to comply with all study related procedures and assessments. Patients who do not have the legal capacity or medical competency to give written informed consent are not eligible for this study; consent via legally authorized representative will not be accepted
  • Patients must be ≥ 40 and ≤ 85 years of age
  • Patients using non-steroidal anti-inflammatory agent must be on a consistent regimen, dose, and medication for at least 8 weeks prior to enrollment
  • Part A only: Ambulatory persons with osteoarthritis (OA) of the knee and baseline pain with a mean of ≥ 4 and ≤ 9 points on the 24-hour mean pain score (on the 11-point Numeric Rating Scale) for at least five of the seven days during the screening period.
  • Part B only: Ambulatory persons with painful osteoarthritis (OA) of the knee for at least six months.
  • Part B only: Patients with OA must have Kellgren-Lawrence scores 1 through 4 in the target knee
  • Part B only: Patients must have a baseline pain ≥6 on the WOMAC Index pain subscale as derived from the KOOS.

Exclusion Criteria:

  • Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the Investigator 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 clinically significant co-existing conditions of the cardiovascular, renal, gastrointestinal, respiratory, nervous, metabolic, or hematologic/ immune systems
  • Patients with a history of diabetes mellitus according to the American Diabetes Association criteria or patients previously diagnosed by a qualified physician as having diabetes (American Diabetes Association Standards of Medical Care in Diabetes 2016)
  • Patients with a history of cardiac rhythm disturbances, abnormal ECG intervals, or use of medications known to impact ECG intervals
  • Patients who have undergone diagnostic arthroscopy of the Target Knee in the previous six months
  • Patients who have undergone arthroscopic surgery in the last two years prior to the screening visit (including microfracture and menisectomy) on the Target Knee.
  • Patients anticipated to have arthroscopic surgery on either knee at any time during the study period
  • History of previous total or partial knee arthroplasty in either knee
  • Part A only: 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 received intra-articular treatment with steroids or hyaluronic acid derivatives within the last 16 weeks prior to screening
  • Patients who use, or have used in the 8 weeks prior to screening, opioid analgesics (with exception of mild opioid analgesics)
  • Patients who have had regenerative joint procedures on any joint including, but not limited to, platelet-rich plasma injections, mesenchymal stem cell transplantation, autologous chondrocyte transplantation, or mosaicplasty
  • Current or history of other joint diseases such as joint dysplasia, crystal-induced arthropathy (such as gout, or calcium pyrophosphate deposition disease evidenced by clinical and/or radiographic means), aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, or neuropathic arthropathy of any cause
  • Any active known or suspected systemic autoimmune disease (except for vitiligo, residual auto-immune hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment for two years, conditions not expected to recur in the absence of an external trigger) or any history of a systemic inflammatory arthritis such as psoriatic, rheumatoid, ankylosing spondylitis or reactive arthritis
  • Patients diagnosed presently and symptomatic with fibromyalgia based on American College of Radiology (ACR) Criteria
  • Patients with a BMI ≥ 40 kg/m2, or whose size exceed the limits of the of the MRI equipment (coil and gantry)
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 NCT03513016
Other Study ID Numbers  ICMJE UBX0101-OAR-101
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 Not Provided
Responsible Party Unity Biotechnology, Inc.
Study Sponsor  ICMJE Unity Biotechnology, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jamie Dananberg, MD UNITY Biotechnology
PRS Account Unity Biotechnology, Inc.
Verification Date May 2019

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