Date: 2016-05-04
Type of
information: Results
phase: 3
Announcement: Results
Company: Merck&Co (USA - NJ) Sun Pharmaceutical Industries (India)
Product: tildrakizumab (MK-3222)
Action
mechanism: monoclonal antibody. Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23.
.
Disease: psoriasis
Therapeutic
area: Autoimmune diseases - Dermatological diseases - Inflammatory diseases
Country: Australia, Canada, Japan, United Kingdom, United StatesAustria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hungary, Italy, The Netherlands, Poland, USA
Trial
details: This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. (NCT01722331 and NCT01729754)
Latest
news:
- On May 4, 2016, Sun Pharmaceutical announced that two pivotal Phase-3 clinical trials evaluating the efficacy and safety of the investigational IL-23p19 inhibitor antibody tildrakizumab (MK-3222) in patients with moderate-to-severe plaque psoriasis met their primary endpoints for both evaluated doses.
The co-primary efficacy endpoints of the placebo controlled studies (MK-3222-010 and MK-3222-011) were: the proportion of participants with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician's Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies.
- The second study (MK-3222-011) also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Tildrakizumab 200mg was superior to etanercept on both PASI 75 and PGA endpoints at week 12, while the 100 mg dose showed superiority to etanercept on PASI 75 only.
- The preparations for submission of a Biologics License Application to the FDA are proceeding. The detailed findings from the Phase-3 clinical trials will be presented at upcoming scientific meetings.
Is
general: Yes
