临床试验/NCT04647240

NCT04647240招募中2 期

A Two Part, Randomized Study of MTX-001 for the Treatment of Non-Healing Venous Stasis Ulcers

Merakris Therapeutics17 个研究点分布在 1 个国家目标入组 80 人开始时间: 2022年2月26日最近更新: 2026年8月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方
入组人数: 80
试验地点: 17
主要终点: Safety and tolerability

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

DL-VSU-201 is a randomized, double-blind, placebo-controlled study in subjects with a non-infected venous stasis ulcer (VSU) that has failed to demonstrate improvement after receiving at least 4 weeks of standard, conventional wound therapy to evaluate the efficacy and safety of MTX-001.

详细描述

DL-VSU-201 is a multi-center, two-part study in patients with VSU (n=80). The lead-in phase of the study (Part 1) enrolled 11 eligible patients. In Part 1, patients were allocated to receive active MTX-001 once weekly or once every two weeks with standard of care. After completion of Part 1, the data was reviewed to determine the administration frequency of Study Product in Part 2 of the Study.

In Part 2, approximately 70 patients will be randomized 1:1 to receive MTX-001 or placebo (0.9% NaCl) with standard of care. Patients will be administered study treatment weekly, as needed.

Patients will receive localized subcutaneous injection of MTX-001 or placebo into and/or around the wound bed during weekly clinic visits over a 12-week period and assessed for safety and efficacy measures at Screening, Baseline, and Weeks 4, 8, and 12. Percent reduction of the wound surface area will be formally collected at Baseline, Weeks 4, 8, and 12. To assess healing, the ulcer will be evaluated by assessing the change in the surface area from Baseline. Overall change in VAS from Baseline to Week 12 will be evaluated and total wound closure will be evaluated at Week 12.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

•Patients who voluntarily give written informed consent to participate in study
•Males and female patients aged 18 to 75 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 1 only
•Males and female patients aged 18 to 90 years inclusive at Screening (date the patient provides written informed consent to participate in study) for Part 2 only
•Patients having a full thickness ulcer that meets the following criteria:
•Ulcer surface area ≥ 4 cm2 and < 25 cm2
•Ulcer surface area hasn't increased or decreased by 40% or more, as assessed within 28 days prior to Baseline
•Ulcer depth ≥ 0.2 cm at the deepest point of the wound, as measured by gently inserting a pre-moistened cotton tipped applicator into the deepest part of the wound.
•Ulcer age < 36 months (1095 days) prior to Baseline (for Part 2 only)
•Received ≥ 28 days of standard, conventional wound therapy with a therapeutic high-compression (≥40 mmHg), multilayer bandaging (e.g. compression hose, custom garments, commercial kits, etc.) prior to the Baseline visit. If clinically necessary, patients may have received other wound treatments as needed (e.g., surgical debridement, pressure offloading, negative pressure and/or hyperbaric oxygen therapy).
•Patient must have previously undergone venous hemodynamic correction via therapeutic compression (≥40 mmHg), surgical venous stripping, sclerotherapy, endovenous laser ablation, and/or endovenous radiofrequency ablation.
•Patient must have adequate circulation to the affected extremity as demonstrated by the most recently measured ankle-brachial index (ABI) greater than or equal to 0.8 and less than or equal to 1.2 or triphasic or biphasic Doppler arterial waveforms at the ankle of the affected leg (as applicable). If patient has undergone lower extremity stenting or bypass where ABI would be considered unreliable to assess microvascular circulation, patients must have transcutaneous oximetry (TcPO2) > 40 mmHg.
•Patient must have VSU caused by underlying venous reflux disease with physiological reflux lasting greater than or equal to 500 milliseconds for superficial veins OR 1.0 seconds for deep veins, as confirmed by most recent Doppler ultrasound venous mapping from Baseline; historical results/confirmation within the previous three years allowed.
•Patients who agree to follow the specified precautions to avoid pregnancy as follows:
•Patients who are female of childbearing potential include any female patient who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea for at least 12 consecutive months). For female patients of childbearing potential, a negative urine pregnancy test is required at Screening and Baseline prior to initiating Study Product. Female patients of childbearing potential must follow 1 of the following approaches:
•Practice actual abstinence from intercourse
•Have a partner with a vasectomy
•Have an intrauterine device
•Must use 2 different forms of highly effective contraception for the duration of the study, and for at least 48 hours after discontinuing study drug. Medically acceptable forms of effective contraception include approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm).
•Male patients with a partner of childbearing potential must use a condom during intercourse for the duration of the study, and for 48 hours after discontinuing study drug.
•Patients who, in the opinion of the Investigator, are capable of communicating effectively with study personnel and are considered reliable, willing, and likely to be cooperative with protocol requirements and attend all required study visits.
•Patients who have the capability to answer surveys and questionnaires written in English.

排除标准

•Patient must not be currently receiving topical antimicrobials and ulcer must not be infected as determined by clinical assessment according to The International Wound Infection Institute (IWII) criteria (e.g. odor, color, visual appearance) rather than culture.
•Ulcer must not have exposed bone, tendon, or ligament.
•Patient must not have another ulcer within 2 cm from the ulcer receiving investigational treatment.
•Female patients who are pregnant, lactating, or planning to become pregnant during the study.
•Patients actively receiving or received any skin graft substitute within 30 days prior to Baseline.
•Patients receiving oral, systemically administered, or lower extremity injectable corticosteroid therapy within 60 days prior to Baseline.
•Patients with angiographic or clinical signs of peripheral arterial disease (PAD)
•Patients with underlying osteomyelitis.
•Patients with an active infection or condition that would interfere with interpretation of study assessments.
•Patients with an HbA1c > 7.0% (Part 1 only) or HbA1c > 10.0% (Part 2 only), as collected at Screening or in the previous 90 days prior to Screening.
•Patients with current deep vein thrombosis (DVT) (Part 2 only)
•Patients with chronic musculoskeletal disorder or any other disease that would limit ambulation.
•Patients with a history of alcohol abuse or illicit drug abuse within 6 months of Baseline which, in the Investigator's opinion, would make the patient inappropriate for enrollment in a clinical study.
•Patients with any other concomitant disease with life expectancy of <12 months from Baseline
•Patients with an unstable psychiatric condition or those not capable of understanding the objectives, nature, or consequences of the study, or who have any condition which, in the Investigator's opinion, would constitute an unacceptable risk to the patient's safety.
•Patients who are currently receiving an investigational drug, have an investigational device in place, or who have participated in an investigational drug or device study within 90 days prior to Baseline. Participation in an observational study within 90 days prior to Baseline does not disqualify a patient from enrolling.
•Patients who have received another regenerative therapy within 30 days prior to Baseline.
•Patients with a Body Mass Index (BMI) > 45 (Part 2 only) or other clinical symptoms (e.g. edema) that do not allow for adequate therapeutic compression.

研究组 & 干预措施

MTX-001

Active Comparator

MTX-001 (human amniotic fluid) solution 0.2 mL/sqcm weekly

干预措施: MTX-001 (human amniotic fluid) (Biological)

Placebo (0.9% saline)

Placebo Comparator

Matching placebo solution 0.2mL/sqcm weekly

干预措施: MTX-001 (human amniotic fluid) (Biological)

结局指标

主要结局

Safety and tolerability

时间窗: Baseline to Week 12

Evaluated via patient and/or Investigator reported adverse events that occur during the study

Preliminary efficacy

时间窗: Baseline to Week 4

Assessed by percentage area reduction of the ulcer surface area from Baseline to Week 4.

次要结局

Total wound closure(Baseline to Week 12)
Ulcer size(Baseline to Week 12)
Change in pain(Baseline to Weeks 4, 8 and 12)
Change in health-related quality of life(Baseline to Week 12)
Change in rate of wound closure(Screening (Day -28) to Week 4.)
Patient Global Impression of Change(Baseline to Week 12)

研究者

发起方

Merakris Therapeutics

申办方类型

Industry

责任方

Sponsor

研究点 (17)

Loading locations...

相似试验

已完成

2 期

A Study of Adalimumab to Treat Sarcoidosis of the SkinSarcoidosis

NCT00274352Pariser, Robert J., M.D.16

Unknown

2 期

Study of DC Vaccination Against GlioblastomaNeoplasmsGliomaGlioblastoma Multiforme

NCT01567202Huashan Hospital100

已完成

2 期

Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic DermatitisAtopic Dermatitis

NCT04504279Forte Biosciences, Inc.154

已完成

2 期

Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS VaccinesCOVID-19

NCT05925127Novavax994

Unknown

3 期

Evaluation of Efficacy and Safety of Specific Immunotherapy With Modified Allergen Extracts of House Dust MitesAllergic Rhinitis

NCT01013116Roxall Medizin120