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CompletedPhase 2

This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Spontaneous Urticaria (CSU) to assess if it is effective and safe.

Key facts

Who runs it
Escient Pharmaceuticals Inc.
Where
Germany, Netherlands, Poland, and Spain16 sites in 4 countriesChoose a country to see its sites
Status
Completed
Phase
Phase 2
People taking part
44 people enrolled
Started
20 Feb 2024
Ended
3 Mar 2025
Type of study
Interventional
Record updated
24 February 2025

Who can take part

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

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Age 18 to 80 years
  • 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)

This trial has no sites in United States.

It has sites in 4 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

To evaluate the efficacy of EP262 compared to placebo in participants with CSU.

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria
Record updated
24 February 2025