2024-512720-11-00进行中（未招募）3 期
A PIVOTAL, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, INTERNATIONAL PHASE III CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF ALLO-APZ2-CVU ON WOUND HEALING OF THERAPY-RESISTANT NON-HEALING CHRONIC VENOUS ULCERS (CVU)
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks
研究概览
简要总结
The aim of this clinical trial is to investigate the efficacy (by monitoring complete wound closure) and safety (by monitoring AEs) of the IP allo-APZ2-CVU, administered topically on target wounds of patients with therapy-resistant non-healing CVU compared to placebo.
详细描述
This is a pivotal, randomized, placebo-controlled, double-blind, multicenter, international phase III clinical trial to investigate the efficacy and safety of the IMP allo-APZ2-CVU on wound healing in patients with therapy-resistant non-healing CVU.
The allogeneic IMP allo-APZ2-CVU contains skin-derived ABCB5-positive dermal mesenchymal stromal cells isolated from skin tissue of healthy donors and stored in a donor cell bank.
Patients will be randomized to be treated with allo-APZ2-CVU or placebo. The patients will undergo treatment with the IMP on Day 0 (V3) and will be followed up for efficacy for 18 weeks (V4 until V14). Three safety follow-up visits will be performed at Month 6 (V15), Month 10 (V16) and Month 16 (V17).
The wound healing process will be documented by standardized photography.
The wound size measurement will start at the first Screening Visit (V1) and will be measured at each following on-site visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Safety follow-up (SFU) period
- 盲法
- Double (Analyst, Carer, Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients at least 18 years old
- •Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler-Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) ≥0.7)), physical examination and dermatological review
- •Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photography
- •If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide
- •Body mass index between 15 and 50 kg/m²
- •Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures
- •Women of childbearing potential must have a negative urine pregnancy test at Visit 1
- •During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA CTCG “Recommendations related to contraception and pregnancy testing in clinical trials", Version 1.2.
排除标准
- •Evidence of the ulcer extending to the underlying muscle, tendon, or bone
- •Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases
- •Pregnant or lactating women
- •Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo
- •Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1
- •Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase
- •Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion)
- •Employees of the sponsor, or employees or relatives of the investigator(s)
- •Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test)
- •Peripheral Artery Disease including claudication with need of treatment or intervention
- •Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis
- •Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1
- •Patients with known hypersensitivity and/or clinical contraindications to the compression systems used in the clinical trial, or inability/unwillingness to tolerate leg ulcer compression systems
- •Acute wound infection of ulcer requiring treatment as judged clinically
- •Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushing-threshold level) at investigator´s discretion
- •Patients who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is an evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment
结局指标
主要结局
Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks
Efficacy: Complete wound closure at Week 18 already persisting for at least two weeks
Safety: Adverse events
Safety: Adverse events
次要结局
- Complete wound closures at each post-baseline follow-up visit
- Wound size change in percent at each post-baseline follow-up visit
- Quality of wound healing at each post-baseline follow-up visit
- Assessment of Quality of Life using the Wound-Quality of Life Questionnaire (W-QoL) as well as the EQ-5D-5L Questionnaire and the SF-36 at V8, V11, V14, V15, V16, V17
- Pain assessment as per numerical rating scale (NRS) on each post-baseline follow-up visit
- Duration of wound closure
- Recurrence of the wound
- Time to complete wound closure
- Physical examination and vital signs at V14
- Assessment of immunogenicity
研究者
office Rheacell (clinical operation department)
Scientific
Rheacell GmbH & Co. KG
研究点 (1)
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相关资讯
RHEACELL's allo-APZ2-CVU Receives EMA Approval for Phase 3 Chronic Venous Ulcer Trial- RHEACELL has secured EMA approval for a Phase 3 trial of allo-APZ2-CVU (NCT06489028) in patients with chronic venous ulcers (CVU).
- The decision follows positive Phase 2b results and FDA approval, highlighting the potential of allo-APZ2-CVU for refractory CVU treatment.
- The trial will enroll 250 patients across 100+ sites in Europe, starting in Q1 2025, focusing on wound healing efficacy and safety.
- allo-APZ2-CVU leverages ABCB5-positive mesenchymal stem cells with immunomodulatory properties to address unmet needs in severe immune and inflammatory diseases.last yearRHEACELL's Allo-APZ2-CVU Receives FDA Approval for Phase 3 Trial in Refractory Chronic Venous Ulcers- RHEACELL's allo-APZ2-CVU, a first-in-class stem cell therapy, has received FDA approval for a Phase 3 trial (NCT06489028) to treat chronic venous ulcers (CVU).
- The pivotal, multi-center trial will enroll 250 patients across 100 sites to assess the efficacy and safety of allo-APZ2-CVU in therapy-resistant, non-healing CVU.
- Allo-APZ2-CVU leverages ABCB5-positive mesenchymal stem cells to modulate the immune response and promote wound healing in patients with severe, inflammation-driven CVU.
- The Phase 3 approval follows positive Phase 2b results, which demonstrated a favorable safety profile and preliminary efficacy compared to placebo in refractory CVU patients.last year