Efficacy, Safety, and Tolerability of Pioglitazone with NB-UVB in Adult Patients with Active Non-Segmental Vitiligo: A Phase 2 Multi-Center Study

Trial ID: 2024-515642-17-00
Sponsor: I.F.O. Istituti Fisioterapici Ospitalieri

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Diseases & Conditions

Vitiligo

Objectives

The primary objective of this phase 2 multi-center study is to evaluate the **efficacy** of Pioglitazone in combination with NB-UVB therapy compared to NB-UVB therapy alone in adult participants with active non-segmental vitiligo. This is assessed through various clinical evaluations over time. The clinical relevance of this objective lies in determining whether the addition of Pioglitazone can enhance the therapeutic outcomes for patients with non-segmental vitiligo, a condition characterized by the loss of skin pigmentation, which can significantly impact quality of life.

Participants

The clinical trial focuses on evaluating the efficacy of Pioglitazone in combination with NB-UVB therapy compared to NB-UVB alone in adult subjects with active **non-segmental vitiligo**. The study population comprises adults aged between 18 and 65 years, inclusive of all genders. Participants are required to have a clinical diagnosis of non-segmental vitiligo for at least six months, with a body surface area involvement of at least 0.5% on the face, confirmed by photographs at screening and baseline. The trial does not include a vulnerable population. Lifestyle considerations such as diet, physical activity, or habits are not specified. The sponsor has not provided information regarding the total number of participants or the selection process for the trial population.

Plans and Procedures

The clinical trial is a **phase 2** multi-center study designed to evaluate the efficacy, safety, and tolerability of **pioglitazone** in adult participants with **non-segmental vitiligo**. The trial employs a randomized, double-blind, controlled design to compare the effects of **pioglitazone** in combination with narrowband ultraviolet B (NB-UVB) therapy against NB-UVB therapy alone. The primary objective is to assess the proportion of subjects achieving VASI-50, defined as at least a 50% improvement in the Vitiligo Area Scoring Index (VASI) from baseline at Week 32. Secondary endpoints include changes in vitiligo-specific quality of life and dermatology quality life index at designated time points.

The trial is expected to last until August 31, 2026, with recruitment starting on November 1, 2024. Participants will be involved in the study for a maximum treatment period of 32 weeks. The sequence of study visits includes an initial screening visit to confirm eligibility, followed by regular follow-up visits to monitor progress and assess treatment efficacy and safety. The end-of-study visit will conclude the participant's involvement, during which final assessments will be conducted. Participants are required to provide informed consent and meet specific inclusion criteria, such as being between 18 and 65 years of age and having a clinical diagnosis of non-segmental vitiligo for at least six months. Conditions that may lead to early termination from the study include withdrawal of consent, non-compliance with study procedures, or adverse events that compromise participant safety.

Treatment

The clinical trial involves the administration of **Pioglitazone Morningside 15mg Tablets** as the experimental medication. Pioglitazone is a chemical substance classified under the ATC code A10BG03. The pharmaceutical form of the medication is a tablet, and it is administered orally. The dosage is set at 15 mg per tablet, with a maximum daily dose of one tablet. The treatment period is limited to a maximum of 32 weeks. The medication is manufactured by Morningside Healthcare Ltd and is not a pediatric formulation. The trial aims to evaluate the efficacy of Pioglitazone in combination with NB-UVB therapy in adult participants with active non-segmental vitiligo.

In addition to the experimental treatment, the study includes a comparator treatment involving NB-UVB therapy alone. NB-UVB, or narrowband ultraviolet B, is a standard-of-care therapy for vitiligo and serves as the control treatment in this trial. The combination of Pioglitazone with NB-UVB will be compared to NB-UVB monotherapy to assess the added benefit of the experimental medication. Participant compliance with the dosing schedule will be monitored throughout the study to ensure adherence to the treatment protocol.

Efficacy

The efficacy of Pioglitazone in the treatment of **non-segmental vitiligo** will be assessed through a series of clinical endpoints. The primary endpoint is the proportion of subjects achieving VASI-50, defined as at least a 50% improvement in the Vitiligo Area Scoring Index (VASI) from baseline, measured at Week 32. Additional efficacy parameters include the percent change from baseline in VASI, facial-VASI, vitiligo extent score (VES), and self-assessment VES (SA-VES), as well as the absolute change from baseline in VASI at designated time points. Changes from baseline in vitiligo-specific quality of life, as measured by the VitiQoL, and the dermatology quality of life index (DLQI) will also be evaluated at specified intervals.

Inclusion and Exclusion Criteria

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Inclusion Criteria

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study; • Adults between 18 Years and 65 Years of all genders; • 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 30 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 cause; status may be confirmed with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state; b. Have undergone a documented hysterectomy and/or bilateral oophorectomy; c. Have medically confirmed ovarian failure. All other female subjects (including female subjects with tubal ligations) are considered childbearing potential. Has a clinical diagnosis of non-segmental vitiligo for at least 6 months BSA ≥0.5% involvement on the face at screening and baseline (confirmed by photographs);

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Exclusion Criteria

Unable to consent (adults lacking capacity); • Partecipants that have diagnosis of other type of vitiligo including segmental and mixed vitiligo; • Has ≥50% leukotrichia on face or body; • Unable to return for follow-up visits; • Pregnant women and/or breastfeeding, or those who have recently delivered a baby within the past 6 months; • Has any other dermatological diseases that would interfere with vitiligo assessments; • History of type I or II diabetes • Has a transplanted organ, which requires continued immunosuppression; • Systemic immunosuppressive medication (oral corticosteroids) within prior 4 weeks; • Currently undergoing UVB light therapy or history of light therapy within the past 8 weeks; • Has a history of any malignancy, except for localized in situ skin carcinoma; • Has had major surgery within 3 months prior to Screening OR has a major surgery planned during the study; • Prior/Concurrent investigational clinical study experience; • Enrolled in a clinical study of any other investigational drug or device; • Diabetes, liver disease, or kidney disease; • Hypoglycemia as defined by fasting blood glucose <70 mg/dL assessed at a fasting study visit; • 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: • Absolute neutrophil count of <2.5 x 109/L (<2500/mm3); • Hemoglobin <10.0 g/dL or hematocrit <30%; • Platelet count below the lower limit of normal (LLN) at Screening; • Absolute lymphocyte count of <0.8 x 109 /L (<800/mm3); • Serum creatinine > upper limit of normal (ULN) or eGFR <60 ml/min/1.73m2 based on the age appropriate calculation. • Enzymes aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >2 times the ULN; • 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; • Creatine kinase (CK) >3 times the ULN and positive urine myoglobin; • 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. • In the investigator's judgment, any concomitant diseases or therapies that might interfere with the reliability of the study analyses.