Tildrakizumab, an Anti-IL-23 Antibody for the Treatment of Refractory Chronic Spontaneous Urticaria – a single-arm, open-label, phase II study (TAILOR-CSU)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Philipps-Universitaet Marburg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

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

Trial duration

2 Mar 2026 → ongoing

Decision date (initial)

2025-09-15

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Almirall Hermal GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To assess the change in UAS (Urticaria Activity Score) 7 from baseline to week 20.

Secondary objectives 14

1. To assess the change in VAS (visual analogue scale) Pruritus from baseline to week 20.
2. To assess the change in UCT (Urticaria Control Test) from baseline to week 20.
3. To assess the change in VAS disease activity from baseline to week 20.
4. To determine the proportion of patients with at least a 50% reduction in UAS7 at week 20.
5. To determine the proportion of patients with UAS7 < 6 at week 20.
6. To determine the proportion of patients with UCT7 > 12 at week 20.
7. To assess the change in the overall CU-Q2oL score from baseline to week 20.
8. To determine the Longitudinal analysis of all the above variables at week 4, 8, 12, 16, 20, 24, and 28 (follow up).
9. To evaluate the safety of tildrakizumab therapy.
10. To determine the proportion of patients with a complete response (UAS7=0)
11. To determine the percentage of angioedema-free days in patients with angioedema.
12. To determine the time to relapse.
13. To determine the proportion of patients with at least a 50% reduction in UAS7 at week 28.
14. To describe immunological changes over time, assessed through specific markers at defined timepoints.

Conditions and MedDRA coding

chronic spontaneous urticaria

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Age ≥ 18 years
2. CSU for ≥ 6 weeks, hives and itching for ≥ 6 weeks despite H1 antihistamine treatment at screening
3. Must be on stable co-medication with H1 blockers
4. IL-17-mediated T-cellular immune profile as determined by ELISPOT assay
5. UAS7 (range 0–42) of ≥ 16
6. Signed written informed consent
7. Negative pregnancy test for women of child bearing potential (WOCBP) at screening
8. WOCBP must agree to use highly effective method of contraception during the entire period from the time of informed consent until at least 17 weeks after the last administration of study medication.
9. Male participants with female partner(s) of childbearing potential are eligible to participate in the study if they agree to the following during treatment and until 90 days after the last administration of study medication: • Inform any and all partner(s) of their participation in a clinical drug study and the need to comply with contraception instructions as directed by the investigator. • Male participants are required to use a condom during treatment and until 90 days after the last administration of study medication. • Female partners of male participants who have not undergone a vasectomy or a bilateral orchiectomy should consider use of effective methods of contraception during treatment and until 90 days after the last administration of study medication. • Sperm donation is not allowed during treatment and until 90 days after the last administration of study medication.

Exclusion criteria 10

1. Primarily subtype of inducible chronic urticaria (e.g. cold, pressure)
2. Current/active autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematodes, multiple sclerosis etc.
3. Immunosuppressive or -modulatory treatments, including omalizumab, the latter for less than 3 half-lives (that means 3 months) before starting treatment at baseline
4. History of malignancy (with the exception of adequately treated non-melanoma skin cancer)
5. Active or latent tuberculosis
6. Any active generalized skin disease like psoriasis or atopic eczema
7. Immunization with live vaccines (planned or within 1 month prior to the study)
8. Pregnant women
9. Breast-feeding women
10. Participation in other clinical trials

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Difference in the UAS7 score from baseline to week 20.

Secondary endpoints 14

1. Difference of VAS pruritus score between baseline and week 20.
2. Difference in the UCT score between baseline and week 20.
3. Difference in the VAS disease activity score from baseline to week 20.
4. Proportion of patients achieving a ≥50% reduction in UAS7 score from baseline to week 20.
5. Proportion of patients achieving a UAS7 score < 6 at week 20.
6. Proportion of patients achieving a UCT7 score > 12 at week 20.
7. Difference in the overall CU-Q2oL score from baseline to week 20.
8. Difference in variables from baseline to weeks 4, 8, 12, 16, 20, 24, and 28 during and after tildrakizumab treatment.
9. Frequency and severity of adverse and serious adverse events.
10. Proportion of patients achieving a complete response (UAS7 = 0) at the specified timepoint
11. Percentage of angioedema-free days (measured by AAS) in patients with angioedema specified follow-up period.
12. Duration from the first occurrence of a ≥50% reduction from baseline UAS7 to the point at which the patient experiences a ≥50% increase from the nadir UAS7 achieved after treatment initiation.
13. Proportion of patients achieving at least a 50% reduction compared to baseline in UAS7 at week 28.
14. Immunological data: blood test at week 0, 4, 8, 16, 20, 28, (ELISPOT IL-17, IL-5, IFN-y, IL-10; flow cytometry: IL-23 and skin homing panel), histology at weeks 0, 20 (flow cytometry: skin panel incl. IL-4, IL-17, IFN-y)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Philipps-Universitaet Marburg

Sponsor organisation

Philipps-Universitaet Marburg

Address

Karl-Von-Frisch-Strasse 4

City

Marburg

Postcode

35043

Country

Germany

Scientific contact point

Organisation

Philipps-Universitaet Marburg

Contact name

Study Coordinator

Public contact point

Organisation

Philipps-Universitaet Marburg

Contact name

Study Coordinator

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 10 files

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

Application history

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