Efficacy of Tildrakizumab in Difficult-to-treat Areas in Psoriasis - ZODIPSO Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Clin4all
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Specific response to Tildrakizumab at W28
研究概览
简要总结
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population.Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis.
Real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
The aim of the ZODIPSO study is to evaluate the efficacy and safety of Tildrakizumab in patients presented difficult to treat locations in psoriasis : nail, scalp, genital and palmoplantar.
The main objective is to assess the overall response and the specific response to Tildrakizumab at these specific areas up to W52.
详细描述
Psoriasis is a chronic inflammatory disease that affects between 2% and 4% of the French population. Some specific localizations are more difficult to manage, such as the scalp, nails, genital region and palmoplantar localizations. They are reported at least once during the course of psoriatic disease in more than 80%, 50%, 60%, 12% of patients, respectively.
Despite recent progress in the management of the disease, these localizations remain a challenge for psoriasis patients because of their impact on quality of life and the difficulty of treating them.
Tildrakizumab, an anti-interleukin-23 (IL-23) monoclonal antibody, has already demonstrated efficacy and safety in the treatment of patients with moderate to severe psoriasis in two international multicenter randomized clinical trials : reSURFACE 1 and reSURFACE 2. However, real-life data on the efficacy of Tildrakizumab in unselected patients with these difficult-to-treat locations are still limited.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a diagnosis of moderate to severe chronic plaque psoriasis documented in the medical record,
- •Disease diagnosis > 6 months (regardless of severity at diagnosis)
- •Involvement of at least one of the following areas: nails, scalp, genital, palmoplantar (non-pustular)
- •Indication for treatment by IL-23 inhibitor. Tildrakizumab must be the selected IL-23 inhibitor therapy prior to enrolling the patient in the study. Patients who have previously received previous treatment by IL-23 inhibitors may be included.
- •Patient 18 years of age or older at the inclusion visit
- •French social security beneficiary
排除标准
- •Patient unable to comply with study requirements (i.e.complete study questionnaires)
- •Patient who, in the opinion of the investigator, should not participate in the study. This opinion should be documented in the patient's record.
- •Patient included in an interventional clinical trial at inclusion.
- •Vulnerable patient or patient under court protection
- •Patients with known hypersensitivity to IL-23 inhibitors
- •Patients with HIV or active HBV or HCV infection at the time of inclusion
- •Patient with a history of untreated latent tuberculosis or active tuberculosis at inclusion
- •Patient with any other serious active infection present at inclusion that contraindicates IL23 inhibitors use.
- •Pregnant or lactating woman
结局指标
主要结局
Specific response to Tildrakizumab at W28
时间窗: Week 28
Percentage of response based on specific assessment on target area (75% improvement of the specific score compared to Baseline visit)
次要结局
- Evaluation of pruritus under treatment(Each visit (Baseline,Week 16, Week 28, Week 52))
- Overall response to Tildrakizumab(Each visit (Week16-Week 28-Week 52))
- Specific response to Tildrakizumab(Week 16, week 28 and week 52)
- Adverse events(From baseline visit to Week 52)
- Evaluation of quality of life under treatement(Each visit (Baseline, Week16, Week 28, Week 52))
- Evaluation of satisfaction under treatement(Each follow-up visit (Week 16, Week 28, Week 52))