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

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

ArmDescriptionAssigned 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
  • Drug: PF-06651600
    Induction dose 1. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
  • Drug: PF06700841
    Oral tablet taken QD
Experimental
Cohort 2
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
  • Drug: PF-06651600
    Induction dose 2. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
  • Device: narrow-band UVB phototherapy
    Phototherapy will be combined with PF-06651600
Experimental
Cohort 3
Maintenance dose A given QD for 24 weeks
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
Experimental
Cohort 4
Maintenance dose B given QD for 24 weeks
  • Drug: PF-06651600
    Maintenance Dose B. Oral tablet taken QD
Experimental
Cohort 5
Maintenance dose C given QD for 24 weeks
  • Drug: PF-06651600
    Maintenance Dose C. Oral tablet taken QD
Placebo Comparator
Cohort 6
Placebo given QD for 24 weeks
  • Drug: placebo
    placebo
Experimental
Extension Cohort 1
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
  • Drug: PF06700841
    Oral tablet taken QD
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
  • Drug: PF-06651600
    Induction dose 1. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
  • Device: narrow-band UVB phototherapy
    Phototherapy will be combined with PF-06651600
Experimental
Extension Cohort 3
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
  • Drug: PF-06651600
    Induction dose 1. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
Experimental
Extension Cohort 4
Maintenance dose A given QD for 24 weeks
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
Experimental
Extension Cohort 5
Maintenance dose B given QD for 24 weeks
  • Drug: PF-06651600
    Maintenance Dose B. Oral tablet taken QD
No Intervention
Extension Cohort 6
Observation period for 24 weeks

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030

More Details

NCT ID
NCT03715829
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.