A Phase 3 Study of Tanezumab for Chronic Low Back Pain
Summary
This study will investigate the efficacy and safety of tanezumab 5 mg and 10 mg administered by subcutaneous injection seven times at 8 week intervals (56 weeks). The primary objective of this study is to evaluate the effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. Secondary objectives are to evaluate the long-term safety and effectiveness of tanezumab 10 mg and 5 mg compared to placebo for the treatment of chronic low back pain. In addition, the study will evaluate the effectiveness and long term safety profile of tanezumab treatment for chronic low back pain compared to tramadol Prolonged Release (PR), a medication commonly utilized for the treatment of chronic low back pain.
Timeline
- Start
- 2015-08-18
- Primary completion
- 2017-10-17
- Completion
- 2018-12-20
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Tanezumab 10 mg met the primary endpoint by significantly improving LBPI at week 16 vs placebo; least squares (LS) mean (95% CI) difference = -0.40 (-0.76 to -0.04; P = 0.0281). reads as mixed primary results PMID 32453139 ↗
paper Tanezumab 5 mg did not meet the primary endpoint (LS mean [95% CI] treatment difference vs placebo = -0.30 [-0.66 to 0.07; P = 0.1117]) reads as mixed primary results PMID 32453139 ↗
release “patients with moderate-to-severe chronic low back pain. In the study, treatment with tanezumab 10 mg met the primary endpoint” reads as met primary endpoint lilly.com ↗
Publications
- Markman JD, Schnitzer TJ, Perrot S, Beydoun SR, Ohtori S, Viktrup L, Yang R, Bramson C, West CR, Verburg KM. Clinical Meaningfulness of Response to Tanezumab in Patients with Chronic Low Back Pain: Analysis From a 56-Week, Randomized, Placebo- and Tramadol-Controlled, Phase 3 Trial. Pain Ther. 2022 Dec;11(4):1267-1285. doi: 10.1007/s40122-022-00424-7. Epub 2022 Aug 13.
- Markman JD, Bolash RB, McAlindon TE, Kivitz AJ, Pombo-Suarez M, Ohtori S, Roemer FW, Li DJ, Viktrup L, Bramson C, West CR, Verburg KM. Tanezumab for chronic low back pain: a randomized, double-blind, placebo- and active-controlled, phase 3 study of efficacy and safety. Pain. 2020 Sep 1;161(9):2068-2078. doi: 10.1097/j.pain.0000000000001928.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tanezumab | Monoclonal antibody | 5 mg | Subcutaneous |
| Subject | Tanezumab | Monoclonal antibody | 10 mg | Subcutaneous |
| Comparator | Tramadol | Other / unclassified | — | Oral |
Indications
No indication recorded.