Trial record 1 of 1 for:
NCT04129944
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 |
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Recruitment Status :
Completed
First Posted : October 17, 2019
Results First Posted : December 29, 2021
Last Update Posted : December 29, 2021
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Sponsor:
Unity Biotechnology, Inc.
Information provided by (Responsible Party):
Unity Biotechnology, Inc.
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis, Knee | Drug: UBX0101 Other: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 183 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of UBX0101 in Moderate to Severe, Painful Osteoarthritis of the Knee |
| Actual Study Start Date : | October 30, 2019 |
| Actual Primary Completion Date : | May 20, 2020 |
| Actual Study Completion Date : | August 7, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo intra-articular injection |
| Experimental: UBX0101 0.5 mg |
Drug: UBX0101
Investigational drug intra-articular injection |
| Experimental: UBX0101 2.0 mg |
Drug: UBX0101
Investigational drug intra-articular injection |
| Experimental: UBX0101 4.0 mg |
Drug: UBX0101
Investigational drug intra-articular injection |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 ]
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 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.
Average Daily Pain (ADP) is assessed by Numerical Rating Score (NRS) on a range from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating higher levels of pain.
- Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 24 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 40 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129944
Locations
Show 20 study locations
Sponsors and Collaborators
Unity Biotechnology, Inc.
Investigators
| Study Director: | Medical Monitor | UNITY Biotechnology |
Study Documents (Full-Text)
Documents provided by Unity Biotechnology, Inc.:
Documents provided by Unity Biotechnology, Inc.:
Study Protocol and Statistical Analysis Plan [PDF] March 17, 2020
| Responsible Party: | Unity Biotechnology, Inc. |
| ClinicalTrials.gov Identifier: | NCT04129944 |
| Other Study ID Numbers: |
UBX0101-MUS-201 |
| First Posted: | October 17, 2019 Key Record Dates |
| Results First Posted: | December 29, 2021 |
| Last Update Posted: | December 29, 2021 |
| Last Verified: | November 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Unity Biotechnology, Inc.:
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Osteoarthritis Painful Osteoarthritis Osteoarthritis, Knee Senescence |
Additional relevant MeSH terms:
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Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |