A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
NCT03715829 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 366
Last updated 2022-03-25
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.
Conditions
- Active Non-segmental Vitiligo
Interventions
- DRUG
-
PF-06651600
Induction dose 1. Oral tablet taken QD
- DRUG
-
PF-06651600
Induction dose 2. Oral tablet taken QD
- DRUG
-
PF-06651600
Maintenance dose A. Oral tablet taken QD
- DRUG
-
PF-06651600
Maintenance Dose B. Oral tablet taken QD
- DRUG
-
PF-06651600
Maintenance Dose C. Oral tablet taken QD
- DRUG
-
placebo
- DRUG
-
PF06700841
Oral tablet taken QD
- DEVICE
-
narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-26
- Primary Completion
- 2021-02-05
- Completion
- 2021-02-05
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Germany
- Italy
- Japan
- South Korea
- Spain
- Taiwan
Study Locations
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