A PHASE 2 MONOCENTRIC PILOT STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PIOGLITAZONE IN SUBJECTS WITH VITILIGO
- Conditions
- MedDRA version: 21.1Level: LLTClassification code 10047643Term: Vitiligo vulgarisSystem Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]ON SEGMENTAL VITILIGO WITH BSA BETWEEN 2% AND 50% AND A NON-SATISFACTORY RESPONSE (LESS THAN 10%) TO A PREVIOUS PHOTOTHERAPY CYCLE
- Registration Number
- EUCTR2021-001442-35-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
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 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.
5.Must meet the following non-segmental vitiligo criteria at the Screening Visit and the Baseline Visit:
a.Have a clinical diagnosis of non-segmental vitiligo for at least 3 months; and
b.Body surface area (BSA) involvement 2% - 50%; and
c.BSA ¿0.2% involvement on the face (confirmed by photographs); and
d. Have obtained <10% response in previous phototherapy treatment.
6.If receiving concomitant medications for any reason other than vitiligo, must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days prior to Day 1. Subject must be willing to stay on a stable regimen during the duration of the study
7.Must agree to avoid prolonged exposure to the sun and not to use tanning booths, sun lamps or other ultraviolet light sources other than provided/requested by the study team during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator,
2.Subjects considered in imminent need for surgery (for example in the next 6 months) or with elective surgery scheduled to occur during the study.
3.Subjects that have other types of vitiligo (including but not limited to segmental vitiligo). Note: Mixed vitiligo is permitted.
4.Currently have active forms of other hypopigmentation . Note: Coexistence of halo nevus/nevi (also known as Sutton nevus/nevi) is permitted.
5.Currently have active forms of inflammatory skin disease(s) or evidence of skin conditions at the time of the Screening or Day 1 Visit that in the opinion of the investigator would interfere with evaluation of vitiligo or response to treatment.
6.Other acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or sponsor, would make the subject inappropriate for entry into this study.
7.Pregnant female subjects; breastfeeding female subjects; and female subjects of childbearing potential who are unwilling or unable to use one method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
8.Have current or recent history of clinically significant severe, progressive, or uncontrolled disease; or have any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results; history of severe allergic or anaphylactoid reaction; or in the opinion of the investigator, the subject is inappropriate for entry into this study, or unwilling/unable to comply with Study Procedures and Lifestyle Requirements.
9. History of type I or II diabetes
10.Have a history of any lymphoproliferative disorder such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
11.Have a history of systemic infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator within 6 months prior to Day 1.
12.Have active acute or chronic skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1, or superficial skin infections within 2 weeks prior to Day 1. NOTE: patients may be rescreened after the infection resolves.
13.Have a history of alcohol or substance abuse within 6 months prior to Day 1 that in the opinion of the investigator will preclude participation in the study or protocol adherence in the study.
14.Have a known immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.
15.Have any malignancies or have a history of malignancies including adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
16.Have undergone significant trauma or major surgery within 1 month of the first dose of IP
17.ANY specific abnorm
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Pioglitazone alone or in association with nbUVB in adult subjects with non-segmental vitiligo.;Secondary Objective: To evaluate the safety and tolerability of Pioglitazone over time in adult subjects with active non-segmental vitiligo.<br>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;Primary end point(s): vitiligo area scoring index (VASI) at Week 12;Timepoint(s) of evaluation of this end point: At week 12
- Secondary Outcome Measures
Name Time Method 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