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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 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
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : December 7, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

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



Primary Outcome Measures :
  1. 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

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


Information from the National Library of Medicine

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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)

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
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United States, California
University of California, Irvine, Dermatology Clinical Research Center Not yet recruiting
Irvine, California, United States, 92697
Vitiligo and Pigmentation Institute Of Southern California Recruiting
Los Angeles, California, United States, 90036
United States, Connecticut
New England Research Associates, LLC Not yet recruiting
Bridgeport, Connecticut, United States, 06606
United States, Florida
Park Avenue Dermatology Recruiting
Orange Park, Florida, United States, 32073
ForCare Clinical Research Recruiting
Tampa, Florida, United States, 33613
United States, Maryland
TrialSpark - Samantha Toerge, MD Recruiting
Chevy Chase, Maryland, United States, 20815
TrialSpark - Ronald Shore, MD Recruiting
Rockville, Maryland, United States, 20852
United States, Massachusetts
UMass Memorial Medical Center Ear Nose and Throat Not yet recruiting
Worcester, Massachusetts, United States, 01655
UMass Memorial Medical Center, Hahnemann Campus Not yet recruiting
Worcester, Massachusetts, United States, 01655
UMass Memorial Medical Center Not yet recruiting
Worcester, Massachusetts, United States, 01655
University of Massachusetts Medical School Not yet recruiting
Worcester, Massachusetts, United States, 01655
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10003
TrialSpark - Lisa Travis, MD Recruiting
New York, New York, United States, 10023
TrialSpark - Russell Cohen, MD Recruiting
Oceanside, New York, United States, 11572
United States, Texas
University Physicians Group Recruiting
Austin, Texas, United States, 78701
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-9191
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Canada, British Columbia
Dr. Chih-ho Hong Medical Inc. Not yet recruiting
Surrey, British Columbia, Canada, V3R 6A7
Enverus Medical Research Not yet recruiting
Surrey, British Columbia, Canada, V3V 0C6
Canada, Ontario
CCA Medical Research Not yet recruiting
Ajax, Ontario, Canada, L1S 7K8
Guenther Research Inc. Recruiting
London, Ontario, Canada, N6A 3H7
Lynderm Research Inc. Not yet recruiting
Markham, Ontario, Canada, L3P 1X2
DermEdge Research Recruiting
Mississauga, Ontario, Canada, L5H 1G9
North York Research Inc. Not yet recruiting
North York, Ontario, Canada, M2M 4J5
The Centre for Dermatology Recruiting
Richmond Hill, Ontario, Canada, L4B 1A5
K.Papp Clinical Research Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2K 4L5
Diex Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1L 0H8
Canada
Centre de Recherche Dermatologique du Quebec metropolitain (CRDQ) Recruiting
Quebec, Canada, G1V 4X7
Japan
Nagoya City University Hospital Not yet recruiting
Nagoya, Aichi, Japan, 467-8602
Tohoku University Hospital Not yet recruiting
Sendai, Miyagi, Japan, 980-8574
Nippon Medical School Hospital Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8603
Tokyo Medical University Hospital Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Yamanashi Prefectural Central Hospital Not yet recruiting
Kofu, Yamanashi, Japan, 400-8506
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03715829     History of Changes
Other Study ID Numbers: B7981019
2018-001271-20 ( EudraCT Number )
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019
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