A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

Pfizer

Status and phase: Completed; Phase 2

Conditions: Active Non-segmental Vitiligo

Treatments: Drug: PF06700841; Device: narrow-band UVB phototherapy; Drug: PF-06651600; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03715829

2018-001271-20 (EudraCT Number)

B7981019

Details and patient eligibility

About

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.

Enrollment: 366 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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366 participants in 12 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Cohort 2

Experimental group

Description:

Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Cohort 3

Experimental group

Description:

Maintenance dose A given QD for 24 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Cohort 4

Experimental group

Description:

Maintenance dose B given QD for 24 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Cohort 5

Experimental group

Description:

Maintenance dose C given QD for 24 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Cohort 6

Placebo Comparator group

Description:

Placebo given QD for 24 weeks

Treatment:

Drug: placebo

Extension Cohort 1

Experimental group

Description:

4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks

Treatment:

Drug: PF06700841

Extension Cohort 2

Experimental group

Description:

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

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Device: narrow-band UVB phototherapy

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Extension Cohort 3

Experimental group

Description:

Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Extension Cohort 4

Experimental group

Description:

Maintenance dose A given QD for 24 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Extension Cohort 5

Experimental group

Description:

Maintenance dose B given QD for 24 weeks

Treatment:

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Drug: PF-06651600

Extension Cohort 6

No Intervention group

Description:

Observation period for 24 weeks