Cara Therapeutics has started dosing patients in the KALM-2 trial, a Phase lll pivotal study of KORSUVA (CR845/difelikefalin) injection to treat haemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).
The international, multicentre, randomised, double-blind, placebo-controlled, 12-week treatment trial is expected to enrol 350 patients in the US, Europe and some countries in the Pacific Rim region.
The trial intends to examine the safety and efficacy of 0.5mcg/kg CR845/difelikefalin injection in the enrolled patients.
The primary efficacy objective of the KALM-2 trial is the proportion of patients achieving at least a three-point improvement from baseline with respect to the weekly mean of the daily 24‑hour worst itching intensity numeric rating scale (NRS) score at week 12.
The trial’s secondary objectives are evaluation of itch-related quality of life changes measured using validated self-assessment 5-D Itch and Skindex-10 scales, as well as the proportion of patients obtaining greater than four-point improvement from baseline in weekly mean of the daily 24-hour worst itching intensity NRS score at week 12.
Cara Therapeutics president and CEO Derek Chalmers said: “The initiation of our second Phase lll efficacy trial in dialysis patients with CKD-aP is an important step toward our goal of developing and commercialising KORSUVA injection as a potential novel treatment option for a patient population with significant unmet medical need.
“We will continue to focus on patient enrolment in the coming quarters and expect data readouts from both our US and global Phase lll trials in 2019.”
KORSUVA has previously received the breakthrough therapy designation from the US Food and Drug Administration (FDA) for use in the treatment of CKD-aP.
No approved therapies are currently available to treat the condition in the US or European Union (EU).
CKD-aP is a difficult systemic itch condition that occurs frequently and at high intensity in patients with chronic kidney disease undergoing hemodialysis and peritoneal dialysis.