KPL-716-C201: A Phase 2A/B, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects with Prurigo Nodularis

Study Details

Main inclusion criteria:

  1. Clinical diagnosis of PN for at least 6 months.
     
  2. Have at least 20 nodules of approximately 0.5 to 2 cm. The nodules must be pruritic and present on at least 2 different anatomical locations (not be localized), involve the extremities, with extensor extremity involvement greater than the flexor extremity involvement. Nodules on the head (face and scalp) are not counted as an anatomical location for eligibility criteria. Each arm, each leg, and trunk are considered different anatomical locations. IGA score of ≥3.
     
  3. Subject has moderate to severe pruritus, defined as WI-NRS ≥7.
Sponsor(s)
Kiniksa
Principal Investigator(s)
Dr. Jonathan Silverberg
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