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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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NCT03715829

Last updated on January 22, 2020
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Study Location
Clinical Science Institute
Santa Monica, California, 90404 United States
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Non-segmental Vitiligo
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT03715829
Pfizer
Active, not recruiting
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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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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 10, 2020) 		363
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018) 		330
Estimated Study Completion Date  ICMJE December 17, 2020
Estimated Primary Completion Date December 17, 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Germany,   Italy,   Japan,   Korea, Republic of,   Spain,   Taiwan,   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/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
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 January 2020

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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