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Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)

Trial Profile

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs INCB 000262 (Primary)
  • Indications Chronic urticaria
  • Focus Proof of concept; Therapeutic Use
  • Acronyms CALM-CSU
  • Sponsors Escient Pharmaceuticals

Most Recent Events

  • 28 Mar 2025 Status changed from suspended to discontinued.
  • 18 Nov 2024 According to an Incyte Pharmaceuticals media release, company will pause enrollment in the ongoing Phase 2 study of MRGPRX2 (INCB000262) in chronic spontaneous urticaria (CSU). The decision was made following the observation of certain in vivo preclinical toxicology findings. These data have been shared with the U.S. Food and Drug Administration (FDA) and Incyte will work closely with the FDA to determine next steps.
  • 18 Nov 2024 Status changed from recruiting to suspended.

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