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

NCT03513016 | Completed Phase 1 FDA Drug

• 1 other identifier: UBX0101-OAR-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 7

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis; Painful Osteoarthritis; Osteoarthritis, Knee; Senescence

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (6)

• Part A: Plasma concentration of UBX0101 over 24 hrs following a single intra-articular injection

  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

  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

  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.

  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).

  Baseline to Week 4

Study Arms (4)

Part A: UBX0101

EXPERIMENTAL

Part A: UBX0101, single intra-articular injection, ascending dose

Drug: UBX0101

Part A: Placebo

PLACEBO COMPARATOR

Part A: Placebo, single intra-articular injection, ascending dose

Other: Placebo

Part B: UBX0101

EXPERIMENTAL

Part B: UBX0101, single intra-articular injection, fixed dose

Drug: UBX0101

Part B: Placebo

PLACEBO COMPARATOR

Part B: Placebo, single intra-articular injection, fixed dose

Other: Placebo

Interventions

UBX0101 DRUG

Investigational drug intra-articular injection

Part A: UBX0101; Part B: UBX0101

Placebo OTHER

Diluent intra-articular injection

Part A: Placebo; Part B: Placebo

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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Biotechnology, Inc.: lead

Study Sites (7)

TriWest Research Associates

El Cajon, California, 92020, United States

Location

BioSolutions Clinical Research Center

La Mesa, California, 91942, United States

Location

Well Pharma Medical Research

Miami, Florida, 33132, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

Clinical Research Consortium

Las Vegas, Nevada, 89119, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jamie Dananberg, MD

  UNITY Biotechnology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 1, 2018
• Study Start: May 16, 2018
• Primary Completion: March 29, 2019
• Study Completion: April 12, 2019
• Last Updated: April 20, 2020

Record last verified: 2020-04

Locations

US (7)