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A clinical research study of 28 weeks to test the safety/tolerability and effectiveness of an investigational study medication (subcutaneous SCH 900222/MK-3222) in improving the signs and symptoms of ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-001740-54

A clinical research study of 28 weeks to test the safety/tolerability and effectiveness of an investigational study medication (subcutaneous SCH 900222/MK-3222) in improving the signs and symptoms of moderate-to-severe chronic plaque psoriasis, and to compare it to an approved medication for the treatment of psoriasis called etanercept. 28 hetes, 3. fázisú, randomizált, aktív komparátor és placebo kontrollos, párhuzamos elrendezésű vizsgálat a subcutan alkalmazású SCH 900222/MK-3222 hatásosságának és biztonságosságának/tolerálhatóságának a felmérésére, amelyet opcionális, a hosszú távú biztonságosságot érintő, kiterjesztett vizsgálat követ, középsúlyos-súlyos, krónikus, plakk típusú pikkelysömörben szenvedő betegeknél

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Extrait

Primary Efficacy Objective: To assess the efficacy of SCH 900222/MK-3222, hereafter referred to as MK-3222, compared to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index from baseline (PASI 75 response) and the proportion of subjects with a Physician’s Global Assessment (PGA) score of “clear” or “minimal” with at least a 2 grade reduction from baseline at Week 12. Primary Safety/Tolerability Objective: To assess the safety/tolerability of MK-3222 in subjects with moderateto-severe chronic plaque psoriasis at Week 12. Extension Study: To assess long-term safety/tolerability of MK-3222 in subjects with moderate-to-severe chronic plaque psoriasis over 4 years.

Critère d'inclusion

  • Moderate To Severe Chronic Plaque Psoriasis

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