2025-523266-24-00招募中2 期
“A phase 2 multi-center study investigating the efficacy, safety and tolerability of pioglitazone in adult participants with non-segmental vitiligo”
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- - Proportion of subjects achieving F-VASI50 (defined as at least 50% improvement in F-VASI from baseline) at Week 16
研究概览
简要总结
The specific object of the present clinical trial is the use of a PPARγ selective activator for the treatment of vitiligo, such as non-segmental vitiligo. The selective PPARγ activator chosen is a thiazolidinediones (TZDs), the pioglitazone (PGZ) will be used simultaneously to the phototherapy treatment.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all the following inclusion criteria at both screening and baseline to be eligible for enrollment into the study: i) Adults between 18 years and 65 years of all genders; ii) Has a clinical diagnosis of non-segmental vitiligo with depigmented areas; iii) Has a face involvement BSA ≥0.3% at screening and baseline. The face will not include the scalp, ears, neck, or surface area of the lips but will include the nose and the eyelids; iv) Has a Total Vitiligo Scoring Index (T-VASI) ≥3 at screening and baseline; v) Has a Facial Vitiligo Area Scoring Index (F-VASI) ≥0.3 at screening and baseline. vi) Previous failure of at least one first-line treatment (e.g. topical corticosteroids or calcineurin inhibitors). vii) Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; viii) Agree to discontinue all other vitiligo treatments from screening until the final follow-up visit in accordance with the washout times reported below in Table
- •ix) Female subjects of childbearing potential (WOCBP) and at risk for pregnancy must agree to use a highly effective method of contraception (confirmed by the investigator) throughout the study and for at least 30 days after the last PGZ dose of assigned treatment and have a negative pregnancy test result on visit 1 and each 4 weeks during the entire study; x) Female subjects of non-childbearing potential must meet at least 1 of the following criteria: • Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state; • Have undergone a documented hysterectomy and/or bilateral oophorectomy; • Have medically confirmed ovarian failure. • All other female subjects (including female subjects with tubal ligations) are considered childbearing potential.
排除标准
- •i. Unable to consent (adults lacking capacity); ii. Participants that have a diagnosis of other types of vitiligo including segmental and mixed vitiligo; iii. Has ≥50% leukotrichia on face or body; iv. Unable to return for follow-up visits; v. Pregnant women and/or breastfeeding, or those who have recently delivered a baby within the past 6 months; vi. Has any other dermatological diseases that would interfere with vitiligo assessments; vii. History of type I or II diabetes viii. Has a transplanted organ, which requires continued immunosuppression; ix. Has a history of any oncological malignancy; x. Familiar atypical multiple mole and melanoma (FAMMM) syndrome; xi. Systemic lupus erythematosus; xii. Dermatomyositis; xiii. Genetic conditions that predispose an individual to skin cancer (Gorlin syndrome, xeroderma pigmentosum); xiv. Bloom syndrome or Cockayne syndrome; xv. Has had major surgery within 3 months before Screening OR has a major surgery planned during the study; xvi. Has hypersensitivity to the active substance or to any of the excipients; xvii. Has cardiac failure or history of cardiac failure (NYHA stages I to IV); xviii. Has current bladder cancer or a history of bladder cancer xix. Has uninvestigated macroscopic haematuria. xx. Any evidence of fluid overload xxi. Prior/Concurrent investigational clinical study experience; xxii. Enrolled in a clinical study of any other investigational drug or device; xxiii. Liver disease, or kidney disease; xxiv. Hypoglycemia as defined by fasting blood glucose <70 mg/dL assessed at a fasting study visit; xxv. ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary: xxvi. Absolute neutrophil count of <2.5 x 109/L (<2500/mm3); xxvii. Hemoglobin <10.0 g/dL or hematocrit <30%; xxviii. Platelet count below the lower limit of normal (LLN) at Screening; xxix. Absolute lymphocyte count of <0.8 x 109 /L (<800/mm3); xxx. Serum creatinine > upper limit of normal (ULN) or eGFR <60 ml/min/1.73m2 based on the age-appropriate calculation. xxxi. Enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 times the ULN; xxxii. Total bilirubin 1.5 times the ULN; subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is ULN; xxxiii. Creatine kinase (CK) >3 times the ULN and positive urine myoglobin; xxxiv. In the opinion of the investigator, have any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject’s participation in the study. xxxv. Patients who, in the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluation.
结局指标
主要结局
- Proportion of subjects achieving F-VASI50 (defined as at least 50% improvement in F-VASI from baseline) at Week 16
- Proportion of subjects achieving F-VASI50 (defined as at least 50% improvement in F-VASI from baseline) at Week 16
次要结局
未报告次要终点
研究者
PRINCIPAL INVESTIGATOR
Scientific
I.F.O. Istituti Fisioterapici Ospitalieri
研究点 (2)
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