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Tildrakizumab, an Anti-IL-23 Antibody for the Treatment of Refractory Chronic Spontaneous Urticaria – a single-arm, open-label, phase II study (TAILOR-CSU)
EU CTIS ID: 2024-513155-32-00
What this study is testing
To assess the change in UAS (Urticaria Activity Score) 7 from baseline to week 20.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- CSU for ≥ 6 weeks, hives and itching for ≥ 6 weeks despite H1 antihistamine treatment at screening
- Must be on stable co-medication with H1 blockers
- IL-17-mediated T-cellular immune profile as determined by ELISPOT assay
- UAS7 (range 0–42) of ≥ 16
- Signed written informed consent
You likely can't join if
- Primarily subtype of inducible chronic urticaria (e.g. cold, pressure)
- Participation in other clinical trials
- Current/active autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematodes, multiple sclerosis etc.
- Immunosuppressive or -modulatory treatments, including omalizumab, the latter for less than 3 half-lives (that means 3 months) before starting treatment at baseline
- History of malignancy (with the exception of adequately treated non-melanoma skin cancer)
- Active or latent tuberculosis
See the full eligibility criteria
- Age ≥ 18 years
- CSU for ≥ 6 weeks, hives and itching for ≥ 6 weeks despite H1 antihistamine treatment at screening
- Must be on stable co-medication with H1 blockers
- IL-17-mediated T-cellular immune profile as determined by ELISPOT assay
- UAS7 (range 0–42) of ≥ 16
- Signed written informed consent
- Negative pregnancy test for women of child bearing potential (WOCBP) at screening
- 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.
- 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.
- Primarily subtype of inducible chronic urticaria (e.g. cold, pressure)
- Participation in other clinical trials
- Current/active autoimmune diseases, such as rheumatoid arthritis, systemic lupus erythematodes, multiple sclerosis etc.
- Immunosuppressive or -modulatory treatments, including omalizumab, the latter for less than 3 half-lives (that means 3 months) before starting treatment at baseline
- History of malignancy (with the exception of adequately treated non-melanoma skin cancer)
- Active or latent tuberculosis
- Any active generalized skin disease like psoriasis or atopic eczema
- Immunization with live vaccines (planned or within 1 month prior to the study)
- Pregnant women
- Breast-feeding women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.