|
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects |
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 THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO |
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. |
Not Provided |
Interventional |
Phase 2 |
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description:
Dose ranging period is a parallel design. Extension period is a sequential design. Masking: Triple (Participant, Investigator, Outcomes Assessor) Masking Description:
Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms. Primary Purpose: Treatment |
Active Non-segmental Vitiligo |
- 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
placebo - Drug: PF06700841
Oral tablet taken QD - Device: narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
|
- Experimental: Cohort 1
Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks Interventions: - Drug: PF-06651600
- Drug: PF-06651600
- Experimental: Cohort 2
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks Interventions: - Drug: PF-06651600
- Drug: PF-06651600
- Experimental: Cohort 3
Maintenance dose A given QD for 24 weeks Intervention: Drug: PF-06651600 - Experimental: Cohort 4
Maintenance dose B given QD for 24 weeks Intervention: Drug: PF-06651600 - Experimental: Cohort 5
Maintenance dose C given QD for 24 weeks Intervention: Drug: PF-06651600 - Placebo Comparator: Cohort 6
Placebo given QD for 24 weeks Intervention: Drug: placebo - Experimental: Extension Cohort 1
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks Intervention: Drug: PF06700841 - 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 Interventions: - Drug: PF-06651600
- Drug: PF-06651600
- Device: 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 Interventions: - Drug: PF-06651600
- Drug: PF-06651600
- Experimental: Extension Cohort 4
Maintenance dose A given QD for 24 weeks Intervention: Drug: PF-06651600 - Experimental: Extension Cohort 5
Maintenance dose B given QD for 24 weeks Intervention: Drug: PF-06651600 - No Intervention: Extension Cohort 6
Observation period for 24 weeks
|
Not Provided |
|
|
|
Recruiting |
330 |
Same as current |
December 14, 2020 |
December 14, 2020 (Final data collection date for primary outcome measure) |
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)
|
Sexes Eligible for Study: | All |
|
18 Years to 65 Years (Adult, Older Adult) |
No |
|
Australia, Belgium, Canada, Germany, Japan, Korea, Republic of, Spain, Taiwan, United States |
|
|
|
NCT03715829 |
B7981019 2018-001271-20 ( EudraCT Number ) |
Not Provided |
Studies a U.S. FDA-regulated Drug Product: | Yes | Studies a U.S. FDA-regulated Device Product: | No |
|
|
Pfizer |
Pfizer |
Not Provided |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
|
Pfizer |
November 2019 |
|