Clinical trial NCT03715829: A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Active Non-segmental Vitiligo
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-10-23
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dose ranging period is a parallel design. Extension period is a sequential design.
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: Percent Change From Baseline in Central Read Facial-Vitiligo Area Scoring Index (F-VASI) at Week 24 - Dose Ranging (DR) Period
timeFrame: Baseline, Week 24 (Baseline was defined as the last measurement prior to Study Day 18)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) up to Week 24 - DR Period
timeFrame: 24 weeks
measure: Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - DR Period
timeFrame: Baseline up to Week 24
measure: Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile up to Week 24 - DR Period
timeFrame: Baseline up to Week 24
measure: Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - DR Period
timeFrame: 24 weeks
measure: Number of Participants With TEAEs and SAEs - Extension (Ext) Period
timeFrame: 24 weeks
measure: Number of Participants With the TEAEs of Anaemia, Neutropenia, Thrombocytopenia and Lymphopenia - Ext Period
timeFrame: 24 weeks
measure: Number of Participants With Clinically Meaningful Changes From Baseline in Lipid Profile - Ext Period
timeFrame: 24 Weeks
measure: Number of Participants With Liver Function Test Values Meeting the Protocol-Specified Discontinuation Criteria - Ext Period
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Central F-VASI75 at Week 24 - DR Period
timeFrame: Week 24
measure: Percentage of Participants Achieving T-VASI50 at Week 24 - DR Period
timeFrame: Week 24
measure: Percent Change From Baseline in T-VASI at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in Central Read F-VASI at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percent Change From Baseline in Local F-VASI at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percent Change From Baseline in SA-VES at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 16 and 24
measure: Absolute Change From Baseline in T-VASI at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving T-VASI50 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving T-VASI75 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving T-VASI90 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving T-VASI100 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Central Read F-VASI50 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percentage of Participants Achieving Central Read F-VASI75 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percentage of Participants Achieving Central Read F-VASI90 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percentage of Participants Achieving Central Read F-VASI100 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 16 and 24
measure: Percentage of Participants Achieving Local F-VASI50 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Local F-VASI75 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Local F-VASI90 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving Local F-VASI100 at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
measure: Change From Baseline in Total VitiQoL Score at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 16 and 24
measure: Change From Baseline in VitiQoL Participation Limitation Domain Score at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 16 and 24
measure: Change From Baseline in VitiQoL Stigma Domain Score at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 16 and 24
measure: Change From Baseline in VitiQoL Behaviors Domain Score at Designated Time Points - DR Period
timeFrame: Baseline, Weeks 4, 16 and 24
measure: Percentage of Participants Achieving sIGA 0 or 1 and at Least a 2-Point Improvement at Week 24 - DR Period
timeFrame: Week 24
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Marvel Research, LLC
state: California
city: Irvine
country: United States
facility: University of California, Irvine, Dermatology Clinical Research Center
state: California
city: Los Angeles
country: United States
facility: Vitiligo and Pigmentation Institute Of Southern California
state: California
city: Murrieta
country: United States
facility: Dermatology Specialist, Inc.
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Bridgeport
country: United States
facility: Brookside Dermatology Associates
state: Connecticut
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Chicago
country: United States
facility: Advanced Skin and MOHS Surgery Center, c/o TrialSpark, Inc.
state: Illinois
city: Chevy Chase
country: United States
facility: Chevy Chase Dermatology Center (TrialSpark, Inc.)
state: Maryland
city: Chevy Chase
country: United States
facility: TrialSpark - Samantha Toerge, MD
state: Maryland
city: Rockville
country: United States
facility: TrialSpark - Ronald Shore, MD
state: Maryland
city: Boston
country: United States
facility: Tobias & Battite, Inc.
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center, Hahnemann Campus
state: Massachusetts
city: Worcester
country: United States
facility: Investigational Drug Service Pharmacy
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center Ear Nose and Throat
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital Department of Dermatology
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Department of Dermatology
state: Minnesota
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Upper West Side Dermatology c/o TrialSpark, Inc
state: New York
city: New York
country: United States
facility: MDCS: Medical Dermatology & Cosmetic Surgery (TrialSpark, Inc.)
state: New York
city: Oceanside
country: United States
facility: South Nassau Dermatology
state: New York
city: Oceanside
country: United States
facility: TrialSpark, Inc. - Russell W. Cohen, MD
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Columbus
country: United States
facility: Remington-Davis, Inc. Clinical Research
state: Ohio
city: Columbus
country: United States
facility: ForeFront Dermatology
state: Ohio
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, PC
state: Oklahoma
city: Austin
country: United States
facility: University Physicians Group
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Pickens Academic Tower
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc
state: Virginia
city: Vienna
country: United States
facility: Tamjidi Skin Institute (TrialSpark, Inc.)
state: Virginia
city: Darlinghurst
country: Australia
facility: The Skin Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research Pty Ltd
state: Queensland
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Hôpital Erasme Dermatology
city: Brussel
country: Belgium
facility: UZ Brussel - Dermatology
city: Gent
country: Belgium
facility: UZ Gent - Dermatology
city: Surrey
country: Canada
facility: Dr. Chih-ho Hong Medical Inc.
state: British Columbia
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc.
state: Manitoba
city: Ajax
country: Canada
facility: CCA Medical Research
state: Ontario
city: London
country: Canada
facility: Guenther Research Inc.
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research
state: Ontario
city: North York
country: Canada
facility: North York Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K.Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ)
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim, Fachbereich Dermatologie und Allergologie, Dermatologische Ambulanz
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen Hautklinik Studienambulanz
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt, Klinik für Dermatologie, Venerologie und Allergologie
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Luebeck CCIM
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Roma
country: Italy
facility: Istituti Fisioterapici Ospitalieri, Istituto di Ricovero e Cura a Carattere Scientifico,
state: RM
city: Nagoya
country: Japan
facility: Nagoya City University Hospital - Dermatology
state: Aichi
city: Sendai
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital
state: Yamanashi
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ezzedine K, Peeva E, Yamaguchi Y, Cox LA, Banerjee A, Han G, Hamzavi I, Ganesan AK, Picardo M, Thaci D, Harris JE, Bae JM, Tsukamoto K, Sinclair R, Pandya AG, Sloan A, Yu D, Gandhi K, Vincent MS, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. J Am Acad Dermatol. 2023 Feb;88(2):395-403. doi: 10.1016/j.jaad.2022.11.005. Epub 2022 Nov 9.