2024-515172-12-00招募中2 期
A Randomized, Double-blind, Vehicle-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Topically Applied TCP-25 in Patients with Epidermolysis Bullosa
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Xinnate AB
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Efficacy of TCP-25 gel as compared with the vehicle in terms of open index wound area until Day 56 relative to the baseline.
研究概览
简要总结
Evaluate efficacy of TCP-25 gel in promoting wound healing and improving EB symptoms in patients with DEB or JEB Safety Objective: Evaluate safety and tolerability, including local tolerability of TCP-25 gel in patients with DEB or JEB
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Safety-Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 65+ years（0-17 Years, 18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patients with documented diagnosis of DEB or JEB, confirmed by genetic testing and/or by a skin biopsy with immunofluorescence mapping. • Patients ≥4 years old. Note: Initially, patients ≥12 years will be enrolled. Enrollment will be open to 4 to 11 year old pediatric patients (both inclusive), after a DMC reviews and provides a positive opinion regarding the safety and tolerability of the IMP in at least 3 patients 12 to 18 years old who have completed at least 4 weeks of IMP use. • The patient has the presence of a well-matched index wound pair which will be included in two respective treatment areas, with a minimum distance of at least 5 cm (2 inches) between the treatment areas.
排除标准
- •The patient has any subtype of EB other than DEB or JEB. • The patient is currently being treated or planned to be treated with systemic antibiotics. Note: Use of preventive and/or anti-inflammatory antibiotic treatment, including doxycycline, on an established treatment regimen (stable dose for ≥6 weeks before the Baseline Visit) is permitted. Use of topical antibiotics on the index wounds within 7 days before the Baseline Visit is prohibited. • Use of systemic corticosteroids >0.2 mg/kg prednisone dose equivalent per day within 30 days or use of topical corticosteroids on index wounds within 7 days before the Screening Visit. Note: Corticosteroids for inhalation, ophthalmic, or intranasal use are permitted. • The patient has a history of any of the following treatments: a. Local topical Filsuvez on the study treatment areas within 1 month before the Screening Visit, b. Local topical gene therapy with Vyjuvek on the study treatment areas within 3 months before the Screening Visit, c. Systemic mesenchymal stem cell treatment, including Ebesenar, within 6 months before the Screening Visit, or d. Cell-gene (graft) therapy, Zevaskyn, for the treatment of EB affecting the treatment areas any time before the Screening Visit. • The patient has a history of or current malignancy over any study treatment area, eg, basal cell carcinoma or squamous cell carcinoma.
结局指标
主要结局
Efficacy of TCP-25 gel as compared with the vehicle in terms of open index wound area until Day 56 relative to the baseline.
Efficacy of TCP-25 gel as compared with the vehicle in terms of open index wound area until Day 56 relative to the baseline.
次要结局
- Key secondary point: Efficacy of TCP-25 gel as compared with the vehicle in terms of proportions of index wounds achieving complete closure of index wound (defined as 100% re-epithelialization without drainage), within Day 56.
- Change in procedural pain using the Wong Baker FACES® Pain Rating Scale Change from baseline in clinical impression of the index wound using the CGI-S scale and the CGI-C score
- TCP-25 plasma concentrations Frequency, intensity, and seriousness of Adverse Events in all treated patients Local tolerability assessment at the area of IMP application Clinically significant changes from baseline in vital signs (systolic and diastolic blood pressure and pulse rate) and physical examination
研究者
Matilda Hugerth
Scientific
Xinnate AB
研究点 (10)
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