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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 October 25, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
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
Not yet recruiting
A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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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
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
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.
Not Provided
Interventional
Phase 2
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
Active Non-segmental Vitiligo
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
330
Same as current
October 21, 2020
April 29, 2020   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03715829
B7981019
2018-001271-20 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2018

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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