- Patient enrollment increased approximately 28% to maintain >80% statistical power for primary endpoint and key registration endpoint of >4-point improvement responder analysis -
- Full trial enrollment expected in fourth quarter of 2020 -
Based on the Independent Data Monitoring Committee’s (IDMC) recommendation, KARE’s trial size will be increased by approximately 28%, from an original enrollment target of 320 patients to 410 patients, to maintain the prespecified statistical power of 80 percent or greater on the trial’s primary endpoint of change from baseline in the weekly mean of the daily 24-hour Itch Numeric Rating Scale (Itch NRS) and key secondary endpoint of proportion of patients achieving a >4 point improvement in Itch NRS score at week 12. The IDMC’s recommendation was based on the results of a prespecified interim conditional power assessment conducted after approximately 50% of the originally targeted patient number completed the designated 12-week treatment period.
“We are pleased with this IDMC recommendation that, with a modest increase in target patient enrollment, keeps us on track for our trial’s conservative statistical power goals for the key secondary >4-point responder endpoint, which is the accepted clinically meaningful endpoint for regulatory approval of therapeutics for pruritic dermatological indications,” said
KARE Phase 2 Trial Design
The KARE Phase 2 trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 410 adult subjects with atopic dermatitis. Subjects are randomized to three tablet strengths of Oral KORSUVA: 0.25mg, 0.5mg and 1mg taken twice daily (BID) versus placebo for 12 weeks followed by 4 weeks of an active extension phase.
KARE’s primary efficacy endpoint is the change from baseline in the weekly mean of the daily 24-hour Itch NRS score at week 12 of the treatment period. The key secondary endpoint for KARE is the assessment of proportion of patients achieving an improvement from baseline of ≥4 points with respect to the weekly mean of the daily 24-hour Itch NRS score at week 12. Itch-related quality of life scores at the end of week 12 are assessed by the total
The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
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 ongoing trials and future development of Oral KORSUVA for pruritus in patients with atopic dermatitis and the potential for Oral KORSUVA to be a first-in-class anti-pruritic product with a favorable safety profile for these 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 Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Stern Investor Relations, Inc.
Source: Cara Therapeutics, Inc.