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Official Title: A Phase 2B randomized, double-blind, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy and safety profile of PF-06651600 with a partially blinded extension period to evaluate efficacy and safety of PF-06651600 and PF-06700841 in subjects with active non-segmental vitiligo.
In Brief: 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.
In Plain English: This trial represents the fruition of years of scientific research to develop this promising drug candidate. The aim of the trial is to evaluate the efficacy and safety of an investigational drug for vitiligo. You may qualify for this study if you:
- Aged 18-65
- Have generalized vitiligo for 3 months or more
- Have active vitiligo lesions on the face or the body.
If you qualify, enrollment will last for up to 60 weeks, or about one year. As part of the study, you will receive all study-related medication and care at no cost to you. You’ll also have appointments at a study clinic near you during your participation. Teams at the trial locations will constantly monitor your health situation to assess the drug safety and see how you’re responding to study drug. A spirit of collaboration binds different institutions and researchers that are conducting the trial in multiple centers across the USA and Canada, and other countries.
Ages Eligible: 18 Years to 65 Years
Start Date: November 26, 2018
Completion Date (estimated): December 14, 2020
Status: Active, recruiting
Study ID from ClinicalTrials.gov: NCT03715829
Other Study ID Numbers: B7981019; 2018-001271-20 (EudraCT Number)
Location: 91 locations across the United States, as well as Australia, Belgium, every province of Canada, Germany, Japan, Republic of Korea, Spain, Taiwan.
Contact: To learn more about this study, you or your doctor may contact Pfizer Clinical Trials Contact Center by phone 1-800-718-1021 or email ClinicalTrials.gov_Inquiries@pfizer.com. Please refer to this study by its NCT number.
FAQOther Questions
- What are risks of oral and topical corticosteroids?
Corticosteroid drugs (like hydrocortisone, and others) are often used for treating vitiligo. By mimicing the effects of hormones your body produces naturally in your adrenal gla...
- Which diseases most commonly accompany vitiligo?
Vitiligo is an autoimmune disease and is frequently associated with other autoimmune diseases, acccording to a 10-year study. The exact diseases that accompany vitiligo can vary...
- Isn't it just a cosmetic disorder?
Contrary to popular belief, vitiligo is not a cosmetic disorder but a systemic disease affecting the largest body organ and other vital systems, with multiple comorbidities. Fo...
Though it is not always easy to treat vitiligo, there is much to be gained by clearly understanding the diagnosis, the future implications, treatment options and their outcomes.
Many people deal with vitiligo while remaining in the public eye, maintaining a positive outlook, and having a successful career.
Copyright (C) Bodolóczki JúliaBy taking a little time to fill in the anonymous questionnaire, you can help researchers better understand and fight vitiligo.