Cara Therapeutics (CARA) Completes Enrollment in I.V. CR845 Phase 2/3 as UP Treatment

November 29, 2016 8:06 AM EST

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Cara Therapeutics, Inc. (Nasdaq: CARA) announced that it has completed patient enrollment for the multi-dose phase of its adaptive Phase 2/3 trial of I.V. CR845 in dialysis patients suffering from moderate-to-severe uremic pruritus (UP). UP is an intractable systemic itch condition in patients with chronic kidney disease (CKD), for which there are no approved therapies in the United States.

“We’re very pleased to have completed enrollment as planned for Part A of the Phase 2/3 trial in pruritus associated with chronic kidney disease, as these eight-week data will determine the optimal dosing to carry forward into planned registration trials. In our previous Phase 2 trial, I.V. CR845 significantly reduced itch and improved the quality of life for dialysis patients with this condition over a two-week treatment period,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to reporting top-line data from Part A of this trial in the first quarter of 2017 and, based on the results, initiating the planned registration phase later in the year.”

About the Phase 2/3 Adaptive Trial

The Phase 2/3 trial is being conducted in a two-part adaptive design:

  • Part A is a randomized, double-blind, placebo-controlled trial of three doses of I.V. CR845 (0.5 mcg/kg, 1.0 mcg/kg, and 1.5 mcg/kg) administered three times per week after dialysis over an eight-week treatment period in 160 patients.
  • Part B will be a randomized, double-blind, placebo-controlled trial of one optimized dose of I.V. CR845 administered three times per week after dialysis over a 12-week treatment period in up to 240 patients.

Primary and secondary endpoints will include itch intensity and quality of life measures associated with pruritus burden, using a series of previously validated self-assessment scales.



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