drugset / Trial / NCT02309359
A Dose-Range Finding Study for ALX-0061 Combination Therapy in Subjects With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to assess the efficacy and safety of dose regimens of ALX-0061 administered subcutaneously (s.c.) in combination with methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) despite MTX therapy, compared with placebo. To assess the effects of ALX-0061 on quality of life, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ALX-0061, and to define the optimal dose regimen for ALX-0061, based on safety and efficacy, for further clinical development.
Timeline
- Start
- 2015-01
- Primary completion
- 2016-08
- Completion
- 2016-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vobarilizumab | Protein / enzyme biologic | 75 mg | Subcutaneous |
| Subject | Vobarilizumab | Protein / enzyme biologic | 150 mg | Subcutaneous |
| Subject | Vobarilizumab | Protein / enzyme biologic | 225 mg | Subcutaneous |
| Background | Methotrexate | Small molecule | — | — |