Frontlight ResearchEarly access
CompletedPhase 2
Dose-ranging study evaluating the efficacy and safety of EVO756 in adults with Chronic Spontaneous Urticaria.
Key facts
- Who runs it
- Evommune Inc.
- Where
- Bulgaria, Germany, Hungary, Italy, Poland, and Spain38 sites in 6 countriesChoose a country to see its sites
- Trial code
- EU 2024-518786-10-01
- U1111-1316-2157
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 63 people enrolled
- Started
- 1 May 2025
- Ended
- 5 Jun 2026
- Type of study
- Interventional
- Record updated
- 4 June 2026
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 9 criteriaShow less
Who can take part
- Male or female, ages ≥ 18 at Screening
- Capable of providing written informed consent and willing and able to comply with study requirements
- Confirmed CSU diagnosis for ≥ 3 months with an inadequate response to H1 antihistamines
- Urticaria Activity Score (UAS7) ≥ 16 at Day 1, with completed UAS entries for a minimum of 4 out of the 7 days prior to Day 1
- Subjects taking H1 antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study
Who cannot take part
- Use of the following medications for the timeframes specified below and while on study: o Biologics (e.g., omalizumab, dupilumab, tezepelumab, ligelizumab) for 120 days or 5 half-lives (whichever is longer) prior to Day 1, o Cyclosporine, methotrexate, sulfonamides, systemic glucocorticoids (e.g., prednisone), or mycophenolate for 28 days prior to Day 1, o Leukotriene inhibitors (e.g., montelukast, zafirlukast) for 14 days prior to Day 1 (if taken for CSU), o H2-receptor antagonists (e.g., ranitidine, famotidine) for 14 days prior to Day 1 (if taken for CSU)
- History of diseases with urticaria or angioedema symptoms, other than CSU and symptomatic dermographism, such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa), and hereditary or acquired angioedema
- Any other skin disease that might confound the assessment of CSU in the Investigator's opinion
- AST, ALT, alkaline phosphatase, or total bilirubin above the ULN at Screening
This trial has no sites in United States.
It has sites in 6 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
To evaluate the efficacy of EVO756 at multiple dose levels compared with placebo
Data and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of EVO756 in Adults with Moderate to Severe Chronic Spontaneous Urticaria.
- Record updated
- 4 June 2026