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Oral difelikefalin phase 2 trial begins for treatment of pruritus in atopic dermatitis

Cara Therapeutics announced the commencement of a phase 2 trial for oral Korsuva for the treatment of pruritus in patients with atopic dermatitis.

The randomized, double-blind, placebo-controlled study will evaluate Korsuva (CR845/difelikefalin) in moderate to severe pruritis in approximately 240 adults with atopic dermatitis, according to a press release.

Difelikefalin is a kappa opioid receptor agonist that targets the peripheral nervous system as well as certain immune cells, according to the release.

Participants will be randomly assigned to three doses of oral difelikefalin, 0.25 mg, 0.5 mg and 1 mg for twice-daily administration, compared with placebo for 12 weeks, along with a 4-week active extension phase.

The primary endpoint is the change from baseline of the daily 24-hour Itch Numeric Rating Scale (I-NRS) score weekly mean at week 12.

Secondary endpoints include change from baseline in itch-related quality of life scores at the end of week 12, as well as the percentage of patients with an improvement from baseline of at least 4 points with respect to the weekly mean of the daily 24-hour I-NRS score at week 12, according to the release.

In phase 2 and 3 trials, Korsuva injection showed statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate to severe chronic kidney disease-associated pruritus, according to the release.

Oral Korsuva is currently in phase 2 trials for the treatment of pruritus in patients with chronic kidney disease and in patients with primary biliary cholangitis.