“Pruritus is a primary, defining feature of atopic dermatitis that significantly impacts patients’ quality of life and remains challenging to manage with current standard of care,” said
Phase 2 Trial Design
The Phase 2 randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 240 adult subjects with AD. Subjects will be randomized to three tablet strengths of Oral KORSUVA: 0.25 mg, 0.5 mg and 1 mg taken twice daily (BID) vs. placebo for 12 weeks followed by a 4-week active extension phase.
The primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Itch Numeric Rating Scale (I-NRS) score at Week 12 of the treatment period. Secondary endpoints include change from baseline in itch-related quality of life scores at the end of Week 12 as assessed by the total Skindex-10 and 5-D itch scales, as well as the proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour I-NRS score at Week 12.
About Pruritus Associated with Atopic Dermatitis
The point prevalence of chronic pruritus in AD ranges from 87% to 100%. Both quality of life and psychosocial well-being are known to negatively correlate with itch severity. The associated psychosocial co-morbidities of pruritus include sleep disruption, altered eating habits, reduced self-esteem, agitation, anxiety and depression.2,3
- Boguniewicz M. Immunol Allergy Clin N Am. 2005; 25(2):333–51; Eichenfeld L et al. Am Acad Dermatol. 2014; 70(2): 338–351; Barbarot S et al. Allergy. 2018; 73(6):1284-1293.
- Mochizuki H, et al. Allergol Int:
Official Journalof the Japanese Society of Allergology. 2017; 66(1):14-21.
- Farmer WS, Marathe KS. Adv Exp Med Biol. 2017; 1027:161-177.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential of Oral KORSUVA (CR845/difelikefalin) as a treatment for patients with AD, or the potential of Oral KORSUVA (CR845/difelikefalin) to be a treatment option for such patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.