Study record
UBX0101 Phase 2 in painful knee osteoarthritis — failed primary endpoint (UNITY Biotechnology, 2020)
Verdict
This randomized Phase 2 trial found no statistically significant benefit of any UBX0101 dose over placebo on 12-week WOMAC-A pain in 183 adults with knee osteoarthritis. UNITY discontinued development of UBX0101 for this indication.
Study facts
| Study | UNITY Biotechnology UBX0101 Phase 2 (NCT04129944) |
| Year | 2020 |
| Model / population | Adults with painful moderate-to-severe knee osteoarthritis. |
| Intervention | Single intra-articular injection of dose-ranging UBX0101 versus placebo. |
| Sample size | 183 |
| Primary endpoint | Change from baseline in WOMAC-A pain at 12 weeks. |
| Main finding | No UBX0101 arm differed significantly from placebo on the primary endpoint; development for knee osteoarthritis was discontinued. |
| PMID / DOI / Registry | PMID not reported; DOI not reported; Registry NCT04129944 |
○ Evidence tier 2 — Human RCT — disease or biomarker endpoint
Record verify: verified against primary source
| Design | Phase 2 randomized double-blind placebo-controlled |
| N | 183 |
| Registry | NCT04129944 |
| Citation status | verified via ClinicalTrials.gov v2 API: NCT04129944 Phase 2 randomized double-blind placebo-controlled single-dose, n=183 ACTUAL, COMPLETED, results posted 2021-12. Follow-up NCT04349956 TERMINATED ('inability to achieve primary or secondary study objectives') |
Identifiers: DOI not reported; PMID not reported; trial registry id verified. Record-level verification and identifier-level status are separate: a record can be fully verified against its primary publication while an identifier that cannot apply to the study type — a trial registry ID for an animal study, for instance — is marked not applicable. No identifier is fabricated, and none is left in a “pending” state.
Five-qualifier claim
| Species / population | Adults with painful moderate-to-severe knee osteoarthritis (n=183). |
| Exposure, route, schedule | Single intra-articular injection of UBX0101 (dose-ranging) vs placebo. |
| Comparator / duration | Randomized, double-blind, placebo-controlled; 12-week primary readout. |
| Endpoint / numeric result | No statistically significant difference vs placebo in WOMAC-A pain at 12 weeks in any UBX0101 arm. Program discontinued. |
| What it did NOT establish | A negative trial: no senolytic clinical benefit shown for knee OA. |