A phase 2 multi-center study investigating the efficacy, safety and tolerability of pioglitazone in adult participants with non-segmental vitiligo

Overview

Sponsor-declared trial summary

Key facts

Sponsor

I.F.O. Istituti Fisioterapici Ospitalieri

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-10-09

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others, Efficacy

To evaluate the efficacy of Pioglitazone in association with NB-UVB compared to NB-UVB alone as measured by other clinical assessments over time in adult subjects with active non-segmental vitiligo.

Conditions and MedDRA coding

non-segmental vitiligo

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

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; • 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);

Exclusion criteria 1

1. • 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of subjects achieving VASI-50 (defined as at least 50% improvement in VASI from baseline) at Week 32. - 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 - Change from baseline in vitiligo specific quality of life (VitiQoL) and dermatology quality life index (DLQI) at designated time points.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

I.F.O. Istituti Fisioterapici Ospitalieri

Sponsor organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Address

Via Elio Chianesi N 53

City

Rome

Postcode

00144

Country

Italy

Scientific contact point

Organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Contact name

Massimo Zeuli

Public contact point

Organisation

I.F.O. Istituti Fisioterapici Ospitalieri

Contact name

Massimo Zeuli

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications