Phase 2 N=364 Randomized Triple-blind Treatment

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

Active Non-segmental Vitiligo

Bottom Line

View on ClinicalTrials.gov: NCT03715829 ↗

Enrolled (actual)

364

Serious AEs

0.9%

Results posted

Mar 2022

Primary outcome: Primary: Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period — -21.2; -21.2; -18.5; -14.6 Percent Change — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: PF-06651600 (Drug); placebo (Drug); PF06700841 (Drug); narrow-band UVB phototherapy (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period	-21.2; -21.2; -18.5; -14.6; -3.0; 2.1	<0.0001 sig
PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period	56; 45; 54; 30; 40; 52	—
PRIMARY Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period	0; 0; 0; 0; 0; 0	—
PRIMARY Number of Participants With TEAEs and SAEs - Extension (Ext) Period	38; 32; 119; 3; 2; 20	—
PRIMARY Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period	0; 0; 0; 1; 0; 1	—
PRIMARY Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period	0; 0; 0; 0; 0	—
PRIMARY Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period	12.1; 8.5; 7.7; 2.7; 2.3; 0	—
SECONDARY Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period	7.9; 4.6; 4.6; 10.6; 4.1; 9.1	—
SECONDARY Percent Change From Baseline in T-VASI at Designated Time Points - DR Period	-2.4; -3.0; -2.6; -5.1; -2.9; -1.4	—
SECONDARY Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period	0.1; 0.4; -0.2; -1.2; 0.0; 0.6	—
SECONDARY Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period	-4.9; 3.1; -5.0; 0.4; -5.3; -6.3	—
SECONDARY Percent Change From Baseline in SA-VES at Designated Time Points - DR Period	2.7; 1.1; -1.1; 4.9; 4.9; 50.4	—
SECONDARY Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period	-0.3; -0.5; -0.6; -1.0; -0.4; -0.2	—
SECONDARY Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period	1.6; 1.5; 0; 2.0; 0; 0	—
SECONDARY Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period	0; 0; 0; 2.2; 0; 0	—
SECONDARY Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period	3.1; 3.0; 1.5; 2.0; 0; 3.0	—
SECONDARY Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 1.5	—
SECONDARY Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period	-3.9; -2.9; -4.4; -4.4; -3.5; -5.1	—
SECONDARY Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period	-1.2; -1.1; -1.7; -1.8; -1.0; -2.5	—
SECONDARY Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period	-1.9; -1.6; -2.4; -1.7; -1.7; -1.8	—
SECONDARY Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period	-0.8; -0.3; -0.2; -0.9; -0.7; -0.7	—
SECONDARY Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period	0; 0; 0; 0; 0; 0	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03715829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.