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

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ClinicalTrials.gov Identifier: NCT03715829
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 19, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE November 26, 2018
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Percent change from baseline of vitiligo area scoring index (VASI) at Week 24. [ Time Frame: baseline, 24 weeks ]
    assessment of overall vitiligo to measure efficacy of PF-06651600
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: baseline up to end of study (56 weeks) ]
  • Number of subjects with change from baseline in laboratory tests results [ Time Frame: baseline to end of study (56 weeks) ]
  • Number of subjects reporting TEAEs [ Time Frame: baseline up to end of study (56 weeks) ]
  • Number of specific clinical laboratory abnormalities [ Time Frame: baseline to end of study (56 weeks) ]
  • Number of treatment emergent serious adverse events (TESAEs) [ Time Frame: baseline to end of study (56 weeks) ]
  • number of subjects who experienced TESAEs [ Time Frame: baseline to end of study (56 weeks) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03715829 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • Percentage of subjects achieving at least 50% improvement in VASI from baseline (VASI50) at Week 24. [ Time Frame: 24 weeks ]
  • Percent change from baseline in VASI [ Time Frame: baseline to week 20 ]
  • Percent change from baseline in facial VASI [ Time Frame: baseline to week 24 ]
  • Percent change from baseline in vitiligo extent score (VES) [ Time Frame: baseline to week 24 ]
  • Percent change from baseline in self assessment vitiligo extent score (SA-VES) [ Time Frame: baseline to week 24 ]
  • Absolute change from baseline in VASI [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving VASI50 [ Time Frame: baseline to week 20 ]
  • Percentage of subjects achieving at least 75% improvement in VASI from baseline (VASI75) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 90% improvement in VASI from baseline (VASI90) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 100% improvement in VASI from baseline (VASI100) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI50 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI75 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI90 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI100 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 50% improvement in VES (VES50) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 75% improvement in VES (VES75) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 90% improvement in VES (VES90) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 100% improvement in VES (VES100) [ Time Frame: baseline to week 24 ]
  • Change from baseline in vitiligo specific quality of life (VitiQoL) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving a static investigator global assessment (sIGA) 0 or 1 and at least 2- point improvement [ Time Frame: week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
  • Percentage of subjects achieving at least 50% improvement in VASI from baseline (VASI50) at Week 24. [ Time Frame: 24 weeks ]
  • Percent change from baseline in VASI [ Time Frame: baseline to week 20 ]
  • Percent change from baseline in facial VASI [ Time Frame: baseline to week 24 ]
  • Percent change from baseline in vitiligo extent score (VES) [ Time Frame: baseline to week 24 ]
  • Percent change from baseline in self assessment vitiligo extent score (SA-VES) [ Time Frame: baseline to week 24 ]
  • Absolute change from baseline in VASI [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving VASI50 [ Time Frame: baseline to week 20 ]
  • Percentage of subjects achieving at least 75% improvement in VASI from baseline (VASI75) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 90% improvement in VASI from baseline (VASI90) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 100% improvement in VASI from baseline (VASI100) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI50 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI75 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI90 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving facial VASI100 [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 50% improvement in VES (VES50) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 75% improvement in VES (VES75) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 90% improvement in VES (VES90) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving at least 100% improvement in VES (VES100) [ Time Frame: baseline to week 24 ]
  • Change from baseline in vitiligo specific quality of life (VitiQoL) [ Time Frame: baseline to week 24 ]
  • Percentage of subjects achieving a static investigator global assessment (sIGA) 0 or 1 and 2 point or greater improvement [ Time Frame: week 24 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Active Non-segmental Vitiligo
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)
330
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 7, 2020
Estimated Primary Completion Date June 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Canada,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715829
Other Study ID Numbers  ICMJE B7981019
2018-001271-20 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP