drugset / Trial / NCT00258713
A 36-Week Extension to Protocol ISA04-03
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
Timeline
- Start
- 2005-09
- Primary completion
- 2006-07
- Completion
- 2006-07
Publications
- Background Gregory CR, Kyles AE, Bernsteen L, Wagner GS, Tarantal AF, Christe KL, Brignolo L, Spinner A, Griffey SM, Paniagua RT, Hubble RW, Borie DC, Morris RE. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation. 2004 Sep 15;78(5):681-5. doi: 10.1097/01.tp.0000131950.75697.71.
- Background Stalder M, Birsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003 Dec;22(12):1343-52. doi: 10.1016/s1053-2498(03)00033-0.
- Background Abel MD, Aspeslet LJ, Freitag DG, Naicker S, Trepanier DJ, Kneteman NM, Foster RT, Yatscoff RW. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001 Feb;20(2):161. doi: 10.1016/s1053-2498(00)00290-4. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Voclosporin | Other / unclassified | 0.2 mg/kg | — |
| Comparator | Voclosporin | Other / unclassified | 0.3 mg/kg | — |
| Comparator | Voclosporin | Other / unclassified | 0.4 mg/kg | — |