2024-513155-32-00尚未招募2 期
Tildrakizumab, an Anti-IL-23 Antibody for the Treatment of Refractory Chronic Spontaneous Urticaria – a single-arm, open-label, phase II study (TAILOR-CSU)
Philipps-Universitaet Marburg1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Difference in the UAS7 score from baseline to week 20.
研究概览
简要总结
To assess the change in UAS (Urticaria Activity Score) 7 from baseline to week 20.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Difference in the UAS7 score from baseline to week 20.
Difference in the UAS7 score from baseline to week 20.
次要结局
- Difference of VAS pruritus score between baseline and week 20.
- Difference in the UCT score between baseline and week 20.
- Difference in the VAS disease activity score from baseline to week 20.
- Proportion of patients achieving a ≥50% reduction in UAS7 score from baseline to week 20.
- Proportion of patients achieving a UAS7 score < 6 at week 20.
- Proportion of patients achieving a UCT7 score > 12 at week 20.
- Difference in the overall CU-Q2oL score from baseline to week 20.
- Difference in variables from baseline to weeks 4, 8, 12, 16, 20, 24, and 28 during and after tildrakizumab treatment.
- Frequency and severity of adverse and serious adverse events.
- Proportion of patients achieving a complete response (UAS7 = 0) at the specified timepoint
- Percentage of angioedema-free days (measured by AAS) in patients with angioedema specified follow-up period.
- 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.
- Proportion of patients achieving at least a 50% reduction compared to baseline in UAS7 at week 28.
- 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)
研究者
Study Coordinator
Scientific
Philipps-Universitaet Marburg
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Extending omalizumab treatment intervals in patients with chronic spontaneous urticaria (EXOTIC trial)2023-506187-14-00Bispebjerg Hospital40
招募中
3 期
Study to see how good and safe Tildrakizumab is in children aged 6 to under 18 years of age with skin patches2023-504447-14-00Sun Pharmaceutical Industries Limited57
已完成
2 期
TUL01101 软膏特应性皮炎Ⅱ期研究CTR20240878250
进行中（未招募）
2 期
在中重度特应性皮炎患者中评价试验性化合物的疗效和安全性的平台研究CTR2025328714
进行中（未招募）
2 期
在中重度特应性皮炎患者中评价试验性化合物的疗效和安全性的平台研究CTR2025328714