A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis - 09/08/11
, Kim Papp, MD, PhD, FRCPC b, Yves Poulin, MD, FRCPC c, Gilles Lauzon, MD, PhD, FRCPC d, Launa Aspeslet, PhD, RAC, COO e, Robert Huizinga, RN, NNC, MSc(Epi), CNeph(C) e, Patrick Mayo, BSc, PhD e, Robert T. Foster, PhD, MPharm e, Randall W. Yatscoff, PhD, FCACB e, Walter P. Maksymowych, BSc, MDChB, LMCC, MRCP, FRCP don behalf of the ISA247 Psoriasis Study Group
Reprint requests: Dr Robert Bissonnette, 1851 Sherbrooke St East, Ste 502, Montreal Qc H2K 4L5.Montreal, Waterloo, Québec City, and Edmonton, Canada
Abstract |
Background |
Use of current oral calcineurin inhibitors for the treatment of psoriasis is limited by toxicity.
Objective |
Evaluate the safety and efficacy of ISA247, a new oral calcineurin inhibitor, in plaque psoriasis patients.
Methods |
This 12-week, randomized, double-blind, placebo-controlled, parallel-group study included 201 plaque psoriasis patients with ≥ 10% body surface area involvement. Patients were randomized to placebo, ISA247 0.5 mg/kg/d, and ISA247 1.5 mg/kg/d groups. End points included a 2-point reduction in the Static Global Assessment score and a 75% reduction in the Psoriasis Area and Severity Index.
Results |
A 2-point SGA reduction was achieved in 0% (placebo), 15.6% (0.5 mg/kg/d), and 45.1% (1.5 mg/kg/d) (P < .0001). A 75% reduction in the Psoriasis Area and Severity Index was achieved in 0% (placebo), 18.2% (0.5 mg/kg/d), and 66.7% (1.5 mg/kg/day) (P < .0001). While serum creatinine increased in patients treated with ISA247 1.5 mg/kg/d, it remained within the normal range.
Limitations |
Longer-term studies are needed to evaluate the effect of ISA247 on renal function.
Conclusion |
ISA247 appears safe and effective for treating moderate to severe psoriasis.
Le texte complet de cet article est disponible en PDF.Abbreviations used : ACE, BSA, CNi, ITT, PASI, SGA
Plan
| Funding sources: This research was funded entirely by the study sponsor, Isotechnika International Inc. Conflict of interest: Drs Yatscoff and Foster are employees of and hold shares in Isotechnika, and have applied for patents for ISA247. Dr Aspeslet is an employee of and holds shares in Isotechnika. Dr Maksymowych holds shares in Isotechnika, and has acted as a consultant for and received honoraria from Isotechnika. Dr Mayo and Mr Huizinga are employees of Isotechnika, while Dr Lauzon has acted as a consultant for Isotechnika. Drs Bissonnette, Papp, and Poulin declare no conflict of interest. |
Vol 54 - N° 3
P. 472-478 - mars 2006 Retour au numéro
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