Overview
Sponsor-declared trial summary
Chronic spontaneous urticaria
To investigate if adult patients with well controlled chronic spontaneous urticaria (CSU) treated with omalizumab can extend treatment intervals and maintain disease control.
Key facts
- Sponsor
- Bispebjerg Hospital
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 12 Jan 2024 → 9 Jan 2026
- Decision date (initial)
- 2023-11-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506187-14-00
- ClinicalTrials.gov
- NCT05916937
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate if adult patients with well controlled chronic spontaneous urticaria (CSU) treated with omalizumab can extend treatment intervals and maintain disease control.
Conditions and MedDRA coding
Chronic spontaneous urticaria
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- A diagnosis of CSU according to the EAACI/GA2LEN/EDF/WAO guidelines
- Age ≥ 18 years
- A UCT score ≥ 12 at week 12 after initiating treatment with 300 mg omalizumab every four weeks.
- Omalizumab naïve prior to initiating treatment with omalizumab.
- Background treatment of 4 antihistamines daily
- Type 1 CSU (negative BHRA)
- Candidate for omalizumab treatment according to Danish practice
Exclusion criteria 8
- Pregnant or breastfeeding women
- Planned pregnancy within 6 months
- Body mass index (BMI) ≥ 100 kilograms
- Any other active skin disease or condition that may interfere with assessment of CSU e.g., atopic dermatitis, bullous pemphigoid, senile pruritus, or psoriasis.
- Use of immunosuppressive drugs e.g., prednisolone, azathioprine, methotrexate, and cyclosporine.
- Predominantly symptoms from chronic inducible urticaria (CIndU)
- Positive BHRA
- Inability to complete study or comply with study procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Absolute difference in average urticaria control test (UCT) score between treatment arms at week 36.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Xolair 150 mg solution for injection in pre-filled syringe
PRD3944941 · Product
- Active substance
- Omalizumab
- Substance synonyms
- IGE-025A, SYN008
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 2700 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03DX05 — OMALIZUMAB
- Marketing authorisation
- EU/1/05/319/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bispebjerg Hospital
- Sponsor organisation
- Bispebjerg Hospital
- Address
- Borgmester Ib Juuls Vej 31
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Bispebjerg Hospital
- Contact name
- Ditte Georgina Zhang
Public contact point
- Organisation
- Bispebjerg Hospital
- Contact name
- Ditte Georgina Zhang
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 40 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-01-12 | 2026-01-09 | 2024-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol - EXOTIC trial 2023-506187-14-00 CLEAN | 1 |
| Protocol (for publication) | D1_Protocol 2023-506187-14-00 | 1 |
| Protocol (for publication) | Protocol - EXOTIC trial NOT FOR PUBLICATION | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Xolair | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-23 | Denmark | Acceptable 2023-10-20
|
2023-11-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Denmark | Acceptable 2025-06-13
|
2025-06-13 |