Knee OsteoarthritisPhase 1NCT04229225
A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the Knee
A Phase 1 study testing UBX0101 in people with Knee Osteoarthritis, run by Unity Biotechnology, Inc. at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- 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
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Jan 2020to 18 Sep 2020
- 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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
First Surgical Hospital
Bellaire, Texas, 77401
Hassman Research Institute
Berlin, New Jersey, 08009
Drug Studies America
Marietta, Georgia, 30060
Arcis Healthcare LLC dba Lowcountry Orthopaedics and Sports Medicine
North Charleston, South Carolina, 29406
Rochester Clinical Research, Inc.
Rochester, New York, 14609
Sundance Clinical Research, LLC
St Louis, Missouri, 63141
Premier Medical Associates
The Villages, Florida, 32159
About this study
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
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).
Read the 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.
- Conditions
- Knee Osteoarthritis
- 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 (IA) injection
PlaceboOther
Placebo intra-articular (IA) injection
| Study group | Role | What they receive |
|---|---|---|
| UBX0101 single dose (SD) | Experimental | 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 Receives: Drug: UBX0101; Other: Placebo |
| UBX0101 repeat dose (RD) | Experimental | 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 Receives: Drug: UBX0101; 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 and repeat dose intra-articular administration of UBX0101 evaluated by the incidence of serious and non-serious adverse events
Measured: Baseline to Week 24
Secondary outcomes (5)
Plasma UBX0101 drug concentrations following IA administration
Measured: 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
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
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
Measured: Baseline to Week 12
Change from baseline to Week 24 of the WOMAC-A score over time in patients receiving UBX0101 versus those receiving placebo
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
Measured: Baseline to Week 24
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
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
Measured: Baseline to Week 12
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
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
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start23 Jan 2020
- Primary completion18 Sep 2020
- Study completion18 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Unity Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229225
- Sponsor's protocol ID
- UBX0101-MUS-102
- Status last verified
- Apr 2020
- First submitted
- 9 Jan 2020
- Last updated
- 19 Oct 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04229225
- Acronym / sponsor ID
- UBX0101-MUS-102
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Painful Osteoarthritis, Osteoarthritis, Knee, Senescence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Unity Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- 18 Sep 2020 (actual)
- First posted
- 18 Jan 2020 (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 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBX0101 single dose (SD) | Experimental | Drug: UBX0101, Other: PlaceboCohort 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 |
| UBX0101 repeat dose (RD) | Experimental | Drug: UBX0101, Other: PlaceboCohort 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 |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (14 listed)
- 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.
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 (IA) injection | Drug | UBX0101 repeat dose (RD), UBX0101 single dose (SD) |
| PlaceboPlacebo intra-articular (IA) injection | Other | UBX0101 repeat dose (RD), UBX0101 single dose (SD) |
Primary outcome
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
5 secondary outcomes
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
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
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
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
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
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 19 Oct 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.
Medical Monitor study director
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 Knee Osteoarthritis, 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 4 inclusion and 14 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 19 Oct 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. 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 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). 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 19 Oct 2020.