Dose-ranging study evaluating the efficacy and safety of EVO756 in adults with Chronic Spontaneous Urticaria.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Evommune Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

Decision date (initial)

2025-06-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Evommune Inc.

External identifiers

EU CT number

2024-518786-10-01

WHO UTN

U1111-1316-2157

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Dose response, Safety, Efficacy

To evaluate the efficacy of EVO756 at multiple dose levels compared with placebo

Secondary objectives 2

1. To evaluate the safety of EVO756
2. Explore changes in quality of life, biomarkers, and genetic variations correlated with disease activity and activity of EVO756

Conditions and MedDRA coding

Moderate to Severe Chronic Spontaneous Urticaria

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

Individual participant data will not be shared.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Male or female, ages ≥ 18 at Screening
2. Capable of providing written informed consent and willing and able to comply with study requirements
3. Confirmed CSU diagnosis for ≥ 3 months with an inadequate response to H1 antihistamines
4. 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
5. Subjects taking H1 antihistamines must be on a stable regimen 4 weeks prior to Day 1 and while on study.

Exclusion criteria 4

1. 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).
2. 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.
3. Any other skin disease that might confound the assessment of CSU in the Investigator's opinion.
4. AST, ALT, alkaline phosphatase, or total bilirubin above the ULN at Screening.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Mean change from baseline in UAS7 at Week 12

Secondary endpoints 6

1. Percent change from baseline in UAS7 at Week 12
2. Mean and percent change from baseline in UAS7 at Weeks 1, 2, 4, 8
3. Mean and percent change from baseline in ISS7 at Weeks 1, 2, 4, 8, 12
4. Mean and percent change from baseline in HSS7 at Weeks 1, 2, 4, 8, 12
5. Mean and percent change from baseline in AAS7 at Weeks 1, 2, 4, 8, 12
6. Proportion of subjects achieving UAS7 ≤ 6 and UAS7 = 0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Evommune Inc.

Sponsor organisation

Evommune Inc.

Address

1891 Page Mill Road

City

Palo Alto

Postcode

94304-1211

Country

United States

Scientific contact point

Organisation

Evommune Inc.

Contact name

Sponsor Physician

Public contact point

Organisation

Evommune Inc.

Contact name

Sponsor Physician

Third parties 11

Locations

6 EU/EEA countries · 38 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 107 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications