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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 : Completed
First Posted : October 23, 2018
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Active Non-segmental Vitiligo Drug: PF-06651600 Drug: placebo Drug: PF06700841 Device: narrow-band UVB phototherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
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
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
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : February 5, 2021
Actual Study Completion Date : February 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks
 Drug: PF-06651600
Induction dose 1. Oral tablet taken QD

Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 2
Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
 Drug: PF-06651600
Induction dose 2. Oral tablet taken QD

Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 3
Maintenance dose A given QD for 24 weeks
 Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD
Experimental: Cohort 4
Maintenance dose B given QD for 24 weeks
 Drug: PF-06651600
Maintenance Dose B. Oral tablet taken QD
Experimental: Cohort 5
Maintenance dose C given QD for 24 weeks
 Drug: PF-06651600
Maintenance Dose C. Oral tablet taken QD
Placebo Comparator: Cohort 6
Placebo given QD for 24 weeks
 Drug: placebo
placebo
Experimental: Extension Cohort 1
4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
 Drug: PF06700841
Oral tablet taken QD
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
 Drug: PF-06651600
Induction dose 1. Oral tablet taken QD

Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD

Device: narrow-band UVB phototherapy
Phototherapy will be combined with PF-06651600
Experimental: Extension Cohort 3
Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
 Drug: PF-06651600
Induction dose 1. Oral tablet taken QD

Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD
Experimental: Extension Cohort 4
Maintenance dose A given QD for 24 weeks
 Drug: PF-06651600
Maintenance dose A. Oral tablet taken QD
Experimental: Extension Cohort 5
Maintenance dose B given QD for 24 weeks
 Drug: PF-06651600
Maintenance Dose B. Oral tablet taken QD
No Intervention: Extension Cohort 6
Observation period for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline in central read facial- vitiligo area scoring index (facial-VASI) at Week 24 [ Time Frame: baseline, 24 weeks ]
    central assessment of facial vitiligo lesion to measure efficacy of PF-06651600

  2. Number of treatment emergent adverse events (TEAEs) [ Time Frame: baseline up to end of study (56 weeks) ]
  3. Number of subjects with change from baseline in laboratory tests results [ Time Frame: baseline to end of study (56 weeks) ]
  4. Number of subjects reporting TEAEs [ Time Frame: baseline up to end of study (56 weeks) ]
  5. Number of specific clinical laboratory abnormalities [ Time Frame: baseline to end of study (56 weeks) ]
  6. Number of treatment emergent serious adverse events (TESAEs) [ Time Frame: baseline to end of study (56 weeks) ]
  7. number of subjects who experienced TESAEs [ Time Frame: baseline to end of study (56 weeks) ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving central read facial VASI 75 (defined as at least 75% improvement in central read facial-VASI from baseline) at Week 24. [ Time Frame: Week 24 ]
  2. Percentage of subjects achieving at least 50% improvement in VASI from baseline (VASI50) at Week 24. [ Time Frame: baseline to 24 weeks ]
  3. Percent change from baseline in VASI [ Time Frame: baseline to week 24 ]
  4. Percent change from baseline in site assessment of the facial VASI [ Time Frame: baseline to week 24 ]
  5. Percent change from baseline in vitiligo extent score (VES) [ Time Frame: baseline to week 24 ]
  6. Percent change from baseline in self assessment vitiligo extent score (SA-VES) [ Time Frame: baseline to week 24 ]
  7. Absolute change from baseline in VASI [ Time Frame: baseline to week 24 ]
  8. Percentage of subjects achieving VASI50 [ Time Frame: baseline to week 20 ]
  9. Percentage of subjects achieving at least 75% improvement in VASI from baseline (VASI75) [ Time Frame: baseline to week 24 ]
  10. Percentage of subjects achieving at least 90% improvement in VASI from baseline (VASI90) [ Time Frame: baseline to week 24 ]
  11. Percentage of subjects achieving at least 100% improvement in VASI from baseline (VASI100) [ Time Frame: baseline to week 24 ]
  12. Percentage of subjects achieving central read and site assessment of the facial VASI50 [ Time Frame: baseline to week 24 ]
  13. Percentage of subjects achieving site assessment of the facial VASI75 [ Time Frame: baseline to week 24 ]
  14. Percentage of subjects achieving central read and site assessment of the facial VASI90 [ Time Frame: baseline to week 24 ]
  15. Percentage of subjects achieving central read and site assessment of the facial VASI100 [ Time Frame: baseline to week 24 ]
  16. Percentage of subjects achieving at least 50% improvement in VES (VES50) [ Time Frame: baseline to week 24 ]
  17. Percentage of subjects achieving at least 75% improvement in VES (VES75) [ Time Frame: baseline to week 24 ]
  18. Percentage of subjects achieving at least 90% improvement in VES (VES90) [ Time Frame: baseline to week 24 ]
  19. Percentage of subjects achieving at least 100% improvement in VES (VES100) [ Time Frame: baseline to week 24 ]
  20. Change from baseline in vitiligo specific quality of life (VitiQoL) [ Time Frame: baseline to week 24 ]
  21. Percentage of subjects achieving a static investigator global assessment (sIGA) 0 or 1 and at least 2- point improvement [ Time Frame: week 24 ]
  22. Percent change from baseline in central read of the facial VASI [ Time Frame: baseline to Week 20 ]
  23. Percentage of subjects achieving central read of the facial VASI75 [ Time Frame: baseline to Week 20 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715829


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03715829    
Other Study ID Numbers: B7981019
2018-001271-20 ( EudraCT Number )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases