A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Purpose
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.
Condition
- Active Non-segmental Vitiligo
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Dose ranging period is a parallel design. Extension period is a sequential design.
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
- Masking Description
- Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Cohort 1 |
Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks |
|
Experimental Cohort 2 |
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks |
|
Experimental Cohort 3 |
Maintenance dose A given QD for 24 weeks |
|
Experimental Cohort 4 |
Maintenance dose B given QD for 24 weeks |
|
Experimental Cohort 5 |
Maintenance dose C given QD for 24 weeks |
|
Placebo Comparator Cohort 6 |
Placebo given QD for 24 weeks |
|
Experimental Extension Cohort 1 |
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks |
|
Experimental Extension Cohort 2 |
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy |
|
Experimental Extension Cohort 3 |
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks |
|
Experimental Extension Cohort 4 |
Maintenance dose A given QD for 24 weeks |
|
Experimental Extension Cohort 5 |
Maintenance dose B given QD for 24 weeks |
|
No Intervention Extension Cohort 6 |
Observation period for 24 weeks |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer