Tildrakizumab for Chronic spontaneous urticaria

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- CSU for ≥ 6 weeks, hives and itching for ≥ 6 weeks despite H1 antihistamine treatment at screening\n- Must be on stable co-medication with H1 blockers\n- IL-17-mediated T-cellular immune profile as determined by ELISPOT assay\n- UAS7 (range 0–42) of ≥ 16\n- Signed written informed consent\n- Negative pregnancy test for women of child bearing potential (WOCBP) at screening\n- 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.\n- 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

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

Primary endpoints

• {"endpoint_text":"- Difference in the UAS7 score from baseline to week 20.","definition_or_measurement_approach":"To assess the change in UAS (Urticaria Activity Score) 7 from baseline to week 20."}

Secondary endpoints

• {"endpoint_text":"- Difference of VAS pruritus score between baseline and week 20.","definition_or_measurement_approach":"Change in VAS pruritus score from baseline to week 20."}
• {"endpoint_text":"- Difference in the UCT score between baseline and week 20.","definition_or_measurement_approach":"Change in Urticaria Control Test (UCT) score from baseline to week 20."}
• {"endpoint_text":"- Difference in the VAS disease activity score from baseline to week 20.","definition_or_measurement_approach":"Change in VAS disease activity score from baseline to week 20."}
• {"endpoint_text":"- Proportion of patients achieving a ≥50% reduction in UAS7 score from baseline to week 20.","definition_or_measurement_approach":"Proportion of participants with ≥50% reduction in UAS7 at week 20 compared to baseline."}
• {"endpoint_text":"- Proportion of patients achieving a UAS7 score < 6 at week 20.","definition_or_measurement_approach":"Proportion of participants with UAS7 < 6 at week 20."}
• {"endpoint_text":"- Proportion of patients achieving a UCT7 score > 12 at week 20.","definition_or_measurement_approach":"Proportion of participants with UCT7 > 12 at week 20."}
• {"endpoint_text":"- Difference in the overall CU-Q2oL score from baseline to week 20.","definition_or_measurement_approach":"Change in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) total score from baseline to week 20."}
• {"endpoint_text":"- Difference in variables from baseline to weeks 4, 8, 12, 16, 20, 24, and 28 during and after tildrakizumab treatment.","definition_or_measurement_approach":"Longitudinal analysis of specified variables at weeks 4, 8, 12, 16, 20, 24 and 28 compared to baseline."}
• {"endpoint_text":"- Frequency and severity of adverse and serious adverse events.","definition_or_measurement_approach":"AE/SAE collection and reporting per study safety monitoring procedures."}
• {"endpoint_text":"- Proportion of patients achieving a complete response (UAS7 = 0) at the specified timepoint","definition_or_measurement_approach":"Proportion of participants with UAS7 = 0 at specified assessment timepoint(s)."}
• {"endpoint_text":"- Percentage of angioedema-free days (measured by AAS) in patients with angioedema specified follow-up period.","definition_or_measurement_approach":"Percentage of angioedema-free days over the specified follow-up period measured by Angioedema Activity Score (AAS)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Time-to-event measure from first ≥50% reduction to subsequent ≥50% increase from nadir UAS7."}
• {"endpoint_text":"- Proportion of patients achieving at least a 50% reduction compared to baseline in UAS7 at week 28.","definition_or_measurement_approach":"Proportion of participants with ≥50% reduction in UAS7 at week 28 vs baseline."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Immunological markers assessed by ELISPOT, flow cytometry and histology at specified weeks (0,4,8,16,20,28 and histology at 0 and 20) per protocol-specified assays."}

Germany

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

05-05-2026

Processing Time Days

258

Number Of Sites

1

Number Of Participants

18

Primary sponsor

Full Name

Philipps-Universitaet Marburg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Almirall Hermal GmbH","duties_or_roles":"Codes: 13; 14 (as listed in CTIS thirdParty sponsorDuties)","organisation_type":"Pharmaceutical company"}