drugset / Trial / NCT01405196
Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The objective of this study is to evaluate and compare efficacy of 3 dose levels of PF-04236921 to placebo in subjects with generalized lupus using a measure called the Systemic Lupus Erythematosus (SLE) Responder Index. The study will evaluate secondary and exploratory measures as well.
Timeline
- Start
- 2011-12
- Primary completion
- 2014-03
- Completion
- 2014-03
Outcome
Missed primary endpoint
paper CONCLUSIONS: PF-04236921 was not significantly different from placebo for the primary efficacy end point in patients with SLE. PMID 27672124 ↗
registry PF-04236921 10 Milligram (10 mg) vs Placebo; p = 0.076 NCT01405196 ↗
registry PF-04236921 50 mg vs Placebo; p = 0.528 NCT01405196 ↗
Publications
- Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
- Wallace DJ, Strand V, Merrill JT, Popa S, Spindler AJ, Eimon A, Petri M, Smolen JS, Wajdula J, Christensen J, Li C, Diehl A, Vincent MS, Beebe J, Healey P, Sridharan S. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial. Ann Rheum Dis. 2017 Mar;76(3):534-542. doi: 10.1136/annrheumdis-2016-209668. Epub 2016 Sep 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PACIBEKITUG | Monoclonal antibody | 10 mg | Subcutaneous |
| Subject | PACIBEKITUG | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | PACIBEKITUG | Monoclonal antibody | 200 mg | Subcutaneous |