CompletedPhase 2

A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

United States, Australia, Belgium366 participantsStarted 2018-11-26

Plain-language summary

This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female subjects between 18-65 years of age, inclusive, at time of informed consent. * Must have moderate to severe active non-segmental vitiligo. Exclusion Criteria: * History of human immunodeficiency virus (HIV) or positive HIV serology at screening, * Infected with hepatitis B or hepatitis C viruses. * Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period

Timeframe: Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period

Timeframe: 24 weeks

Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period

Timeframe: Baseline up to Week 24

Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period

Timeframe: Baseline up to Week 24

Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period

Timeframe: 24 weeks

Number of Participants With TEAEs and SAEs - Extension (Ext) Period

Timeframe: 24 weeks

Trial details

NCT IDNCT03715829

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-02-05

Results submitted2022-01-10

View on ClinicalTrials.gov More Active Non-segmental Vitiligo trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period

Timeframe: Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period

Timeframe: 24 weeks

Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period

Timeframe: Baseline up to Week 24

Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period

Timeframe: Baseline up to Week 24

Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period

Timeframe: 24 weeks

Number of Participants With TEAEs and SAEs - Extension (Ext) Period

Timeframe: 24 weeks