drugset / Trial / NCT02718716
Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia.
Timeline
- Start
- 2016-03-02
- Primary completion
- 2019-02-04
- Completion
- 2019-02-04
Publications
- Results Robak T, Kazmierczak M, Jarque I, Musteata V, Trelinski J, Cooper N, Kiessling P, Massow U, Woltering F, Snipes R, Ke J, Langdon G, Bussel JB, Jolles S. Phase 2 multiple-dose study of an FcRn inhibitor, rozanolixizumab, in patients with primary immune thrombocytopenia. Blood Adv. 2020 Sep 8;4(17):4136-4146. doi: 10.1182/bloodadvances.2020002003.
- Smith B, Kiessling A, Lledo-Garcia R, Dixon KL, Christodoulou L, Catley MC, Atherfold P, D'Hooghe LE, Finney H, Greenslade K, Hailu H, Kevorkian L, Lightwood D, Meier C, Munro R, Qureshi O, Sarkar K, Shaw SP, Tewari R, Turner A, Tyson K, West S, Shaw S, Brennan FR. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018 Oct;10(7):1111-1130. doi: 10.1080/19420862.2018.1505464. Epub 2018 Sep 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rozanolixizumab | Monoclonal antibody | 4 mg/kg | Subcutaneous |
| Subject | Rozanolixizumab | Monoclonal antibody | 7 mg/kg | Subcutaneous |
| Subject | Rozanolixizumab | Monoclonal antibody | 10 mg/kg | Subcutaneous |
| Subject | Rozanolixizumab | Monoclonal antibody | 15 mg/kg | Subcutaneous |
| Subject | Rozanolixizumab | Monoclonal antibody | 20 mg/kg | Subcutaneous |