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TerminatedPhase 2

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

Key facts

Who runs it
Escient Pharmaceuticals, Inc
Where
Asheville, Baltimore, Birmingham, Boise, Cincinnati, Destin, Fountain Valley, Horseheads, Huntington Beach, Indianapolis, Johnston, Little Rock, Los Angeles, Miami, Missoula, Murray, New Albany, New York, North Charleston, North Las Vegas, Overland Park, Owensboro, Pittsburgh, Plainfield, Pompano Beach, San Antonio, Scottsdale, St Louis, Tampa, Toledo, Tulsa, and White Marsh, United StatesSee the 34 sitesAlso in 5 other countries, 14 sites
Trial code
Status
Terminated
Phase
Phase 2
People taking part
113 people enrolled
Started
25 Sept 2023
Ended
16 Jan 2025
Type of study
Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Oral EP262
  • Placebo
Record updated
19 December 2025
Why it stopped
Strategic Business Decision

Who can take part

Age
18 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • Documented history of chronic spontaneous urticaria (CSU) with a UAS7 greater than or equal to 16 despite stable treatment with H1 antihistamine consistent with standard of care
  • Must be on a stable dose of H1 antihistamine up to 4 times the approved dose per local treatment guidelines

Who cannot take part

  • Other active skin diseases associated with chronic pruritus (eg, atopic dermatitis, bullous pemphigoid, prurigo nodularis, dermatitis herpetiformis)
  • Urticaria with a clear underlying etiology other than CSU
  • Urticaria with a clearly defined or sole trigger (chronic inducible urticaria)

Where in United States

Also in 5 other countries, 14 sites

  • Allergy Partners Clinical ResearchAsheville, United States
  • Johns Hopkins UniversityBaltimore, United States
  • AllerVie Clinical ResearchBirmingham, United States
  • Treasure Valley Medical ResearchBoise, United States
  • Bernstein Clinical Research Center, LLCCincinnati, United States
  • Allervie Clinical ResearchDestin, United States
  • First Oc Dermatology Research IncFountain Valley, United States
  • Corning Center For Clinical ResearchHorseheads, United States
  • Allergy and Asthma Specialists Medical GroupHuntington Beach, United States
  • Dawes Fretzin Clinical Research Group, LLCIndianapolis, United States
  • Clinical Partners LLCJohnston, United States
  • Little Rock Allergy & Asthma Clinical Research CenterLittle Rock, United States
  • Antelope Valley Clinical TrialsLos Angeles, United States
  • Florida Center for Allergy and Asthma ResearchMiami, United States
  • University of Miami Itch CenterMiami, United States
  • Montana Medical Research, IncMissoula, United States
  • Allergy Associates of UtahMurray, United States
  • Southern Indiana Clinical trialsNew Albany, United States
  • Bobby Buka MD, PCNew York, United States
  • National Allergy and Asthma Research, LLCNorth Charleston, United States
  • Las Vegas Clinical TrialsNorth Las Vegas, United States
  • Velocity Clinical Research, Overland Park, KC Asthma & AllergyOverland Park, United States
  • Allergy & Asthma Specialists, P.S.C.Owensboro, United States
  • Allergy and Clinical Immunology AssociatesPittsburgh, United States
  • The Indiana Clinical Trials CenterPlainfield, United States
  • NuLine Clinical Trial CenterPompano Beach, United States
  • Progressive Clinical Research, PASan Antonio, United States
  • Scottsdale Clinical TrialsScottsdale, United States
  • The Clinical Research Center, LLCSt Louis, United States
  • Advanced Clinical Research InstituteTampa, United States
  • University of South FloridaTampa, United States
  • Toledo Institute of Clinical Research Inc.Toledo, United States
  • Vital Prospects Clinical Research Institute., PCTulsa, United States
  • Chesapeake Clinical Research, Inc.White Marsh, United States

About the trial

What the trial wants to find out

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

The 4 groups in the trial

  • EP262 50 mgTreatment being tested

    Treatment: Oral EP262

  • EP262 150 mgTreatment being tested

    Treatment: Oral EP262

  • PlaceboPlacebo, for comparison
  • EP262 25 mgTreatment being tested

    Treatment: Oral EP262

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria (CALM-CSU)
Record updated
19 December 2025