A PHASE 2 MONOCENTRIC PILOT STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PIOGLITAZONE IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO

INTERVENTION: Product Name: Pioglitazone Product Code: [PTZ] Pharmaceutical Form: Tablet INN or Proposed INN: PIOGLITAZONE CLORIDRATO Current Sponsor code: PTZ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ CONDITION: NON SEGMENTAL VITILIGO WITH BSA BETWEEN 2% AND 50% AND A NON‐SATISFACTORY RESPONSE (LESS THAN 10%) TO A PREVIOUS PHOTOTHERAPY CYCLE ; MedDRA version: 21.1 Level: LLT Classification code 10047643 Term: Vitiligo vulgaris System Organ Class: 100000004858 Therapeutic area: Diseases [C] ‐ Skin and Connective Tissue Diseases [C17] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of Pioglitazone alone or in association with nbUVB in adult subjects with non‐segmental vitiligo. Primary end point(s): vitiligo area scoring index (VASI) at Week 12 Secondary Objective: To evaluate the safety and tolerability of Pioglitazone over time in adult subjects with active non‐segmental vitiligo.; To evaluate the efficacy of Pioglitazone alone or in association with nbUVB as measured by other clinical assessments over time in adult subjects with active non‐segmental vitiligo Timepoint(s) of evaluation of this end point: At week 12 SECONDARY OUTCOME: Secondary end point(s): • Incidence of treatment‐emergent adverse events (AEs) and serious adverse events (SAEs) up to Week 16.; • Percent change from baseline in VASI, facial‐VASI, vitiligo extent score (VES), and self‐assessment VES (SA‐VES) and absolute change from baseline in VASI at designated time points Timepoint(s) of evaluation of this end point: At weeks 16; at week 12 INCLUSION CRITERIA: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 3. Male or female subjects between 18‐65 years of age, inclusive, at time of informed consent. 4. Female subjects of childbearing potential and at risk for pregnancy must agree to use one method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non‐childbearing potential must meet at least 1 of the following criteria: a. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological caus