Pioglitazone for Vitiligo

Inclusion criteria

• {"criterion_text":"- Subjects must meet all the following inclusion criteria at both screening and baseline to be eligible for enrollment into the study: i)\tAdults between 18 years and 65 years of all genders; ii)\tHas a clinical diagnosis of non-segmental vitiligo with depigmented areas; iii)\tHas 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)\tHas a Total Vitiligo Scoring Index (T-VASI) ≥3 at screening and baseline; v)\tHas a Facial Vitiligo Area Scoring Index (F-VASI) ≥0.3 at screening and baseline. vi)\tPrevious failure of at least one first-line treatment (e.g. topical corticosteroids or calcineurin inhibitors). vii)\tEvidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; viii)\tAgree to discontinue all other vitiligo treatments from screening until the final follow-up visit in accordance with the washout times reported below in Table 2. ix)\tFemale 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)\tFemale subjects of non-childbearing potential must meet at least 1 of the following criteria: •\tAchieved 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; •\tHave undergone a documented hysterectomy and/or bilateral oophorectomy; •\tHave medically confirmed ovarian failure. •\tAll other female subjects (including female subjects with tubal ligations) are considered childbearing potential."}

Exclusion criteria

• {"criterion_text":"- i.\tUnable to consent (adults lacking capacity); ii.\tParticipants that have a diagnosis of other types of vitiligo including segmental and mixed vitiligo; iii.\tHas ≥50% leukotrichia on face or body; iv.\tUnable to return for follow-up visits; v.\tPregnant women and/or breastfeeding, or those who have recently delivered a baby within the past 6 months; vi.\tHas any other dermatological diseases that would interfere with vitiligo assessments; vii.\tHistory of type I or II diabetes viii.\tHas a transplanted organ, which requires continued immunosuppression; ix.\tHas a history of any oncological malignancy; x.\tFamiliar atypical multiple mole and melanoma (FAMMM) syndrome; xi.\tSystemic lupus erythematosus; xii.\tDermatomyositis; xiii.\tGenetic conditions that predispose an individual to skin cancer (Gorlin syndrome, xeroderma pigmentosum); xiv.\tBloom syndrome or Cockayne syndrome; xv.\tHas had major surgery within 3 months before Screening OR has a major surgery planned during the study; xvi.\tHas hypersensitivity to the active substance or to any of the excipients; xvii.\tHas cardiac failure or history of cardiac failure (NYHA stages I to IV); xviii.\tHas current bladder cancer or a history of bladder cancer xix.\tHas uninvestigated macroscopic haematuria. xx.\tAny evidence of fluid overload xxi.\tPrior/Concurrent investigational clinical study experience; xxii.\tEnrolled in a clinical study of any other investigational drug or device; xxiii.\tLiver disease, or kidney disease; xxiv.\tHypoglycemia as defined by fasting blood glucose <70 mg/dL assessed at a fasting study visit; xxv.\tANY 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.\tAbsolute neutrophil count of <2.5 x 109/L (<2500/mm3); xxvii.\tHemoglobin <10.0 g/dL or hematocrit <30%; xxviii.\tPlatelet count below the lower limit of normal (LLN) at Screening; xxix.\tAbsolute lymphocyte count of <0.8 x 109 /L (<800/mm3); xxx.\tSerum creatinine > upper limit of normal (ULN) or eGFR <60 ml/min/1.73m2 based on the age-appropriate calculation. xxxi.\tEnzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 times the ULN; xxxii.\tTotal 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.\tCreatine kinase (CK) >3 times the ULN and positive urine myoglobin; xxxiv.\tIn 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.\tPatients who, in the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluation."}

Primary endpoints

• {"endpoint_text":"-\tProportion of subjects achieving F-VASI50 (defined as at least 50% improvement in F-VASI from baseline) at Week 16","definition_or_measurement_approach":"F-VASI50 defined as at least 50% improvement in Facial Vitiligo Area Scoring Index (F-VASI) from baseline; measured at Week 16"}

Italy

Earliest CTIS Part Ii Submission Date

20-11-2025

Latest Decision Or Authorization Date

26-11-2025

Processing Time Days

6

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

I.F.O. Istituti Fisioterapici Ospitalieri

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy