Osteoarthritis, KneePhase 1NCT03513016
A Safety and Tolerability Study of UBX0101 in Patients With Osteoarthritis of the Knee
A Phase 1 study testing UBX0101 in people with Osteoarthritis, Knee, run by Unity Biotechnology, Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- UBX0101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 May 2018to 12 Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Metroplex Clinical Research Center
Dallas, Texas, 75231
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Associates
El Cajon, California, 92020
Center for Pharmaceutical Research
Kansas City, Missouri, 64114
BioSolutions Clinical Research Center
La Mesa, California, 91942
Clinical Research Consortium
Las Vegas, Nevada, 89119
Well Pharma Medical Research
Miami, Florida, 33132
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- UBX0101, Placebo
- Keywords
- Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UBX0101Drug
Investigational drug intra-articular injection
PlaceboOther
Diluent intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: UBX0101 | Experimental | Part A: UBX0101, single intra-articular injection, ascending dose Receives: Drug: UBX0101 |
| Part A: Placebo | Placebo comparator | Part A: Placebo, single intra-articular injection, ascending dose Receives: Other: Placebo |
| Part B: UBX0101 | Experimental | Part B: UBX0101, single intra-articular injection, fixed dose Receives: Drug: UBX0101 |
| Part B: Placebo | Placebo comparator | Part B: Placebo, single intra-articular injection, fixed dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a single intra articular injection of UBX0101 evaluated by the incidence of serious and non-serious adverse events
Measured: 12 weeks
Secondary outcomes (6)
Part A: Plasma concentration of UBX0101 over 24 hrs following a single intra-articular injection
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: Baseline to Week 4
Part B: Plasma concentration of UBX0101 following a single intra-articular injection
Measured: 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start16 May 2018
- Primary completion29 Mar 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jamie Dananberg, MD, Study chair, UNITY Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513016
- Sponsor's protocol ID
- UBX0101-OAR-101
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2018
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03513016
- Acronym / sponsor ID
- UBX0101-OAR-101
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Unity Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 May 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 1 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: UBX0101 | Experimental | Drug: UBX0101Part A: UBX0101, single intra-articular injection, ascending dose |
| Part A: Placebo | Placebo comparator | Other: PlaceboPart A: Placebo, single intra-articular injection, ascending dose |
| Part B: UBX0101 | Experimental | Drug: UBX0101Part B: UBX0101, single intra-articular injection, fixed dose |
| Part B: Placebo | Placebo comparator | Other: PlaceboPart B: Placebo, single intra-articular injection, fixed dose |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UBX0101Investigational drug intra-articular injection | Drug | Part A: UBX0101, Part B: UBX0101 |
| PlaceboDiluent intra-articular injection | Other | Part A: Placebo, Part B: Placebo |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Dananberg, MD study chair
UNITY Biotechnology
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UBX0101 in people with Osteoarthritis, Knee, run by Unity Biotechnology, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.