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The study is formulated to evaluate the safety and efficacy of Oral KORSUVA for moderate to severe pruritus
Biopharmaceutical firm Cara Therapeutics Inc. has reportedly announced the initiation of their Phase 2 trial of Oral KORSUVATM for pruritus treatment in patients diagnosed with atopic dermatitis (AD). Evidently, AD is one of the leading chronic inflammatory diseases with occurrence rates of close to 25% in children and approximately 5% in adults.
Dr. Derek Chalmers, Cara President and CEO, was quoted saying that pruritus is a key defining feature of AD that considerably affects patients’ quality of life. He added that the company looks forward to initiating the Phase 2 trial to evaluate Oral KORSUVA as a potential oral treatment option for the treatment of pruritus.
Apparently, the Phase 2 randomized, placebo-controlled, double-blind study is formulated to evaluate the safety and efficacy of Oral KORSUVA for moderate to severe pruritus in 240 adult patients having AD. The subjects will be randomly administered with three tablet strengths of the drug, 0.25mg, 0.5mg and 1mg, taken twice daily vs. placebo for 12 weeks followed by a 4-week active extended phase.
Sources familiar with the study reported that the primary efficacy endpoint will be the change from reference point in the weekly mean of the 24hour I-NRS score at week 12. Whereas the secondary endpoints includes change from starting point in itch-related scores at the end of the 12th week as evaluated by Skindex 5-D and 10 itch scales, as well as the number of patients reaching baseline of more than or equal to 4 points with respect to the weekly mean of the daily 24 hour I-NRS score at week 12.
It has come to the fore that the point occurrence of chronic pruritus in AD ranges between 87% and 100%. Seemingly, both psychosocial well-being and quality of life are known to correlate with the severity of the itch.
Source credit: http://ir.caratherapeutics.com/news-releases/news-release-details/cara-therapeutics-announces-initiation-phase-2-trial-oral-0
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