Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02974868
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: PF-06651600 Drug: PF-06700841 Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model Description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD
Actual Study Start Date : December 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
PF-06651600
Drug: PF-06651600
200 mg QD during induction and 50 mg QD during Maintenance

Experimental: Cohort 2
PF-06700841
Drug: PF-06700841
60 mg QD during induction and 30 mg QD during maintenance

Placebo Comparator: Cohort placebo
placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Change from baseline of Severity of Alopecia Tool (SALT) score at Week 24. [ Time Frame: baseline, 24 weeks ]
    assessment of the overall severity of alopecia areata

  2. Incidence of treatment emergent adverse events (AEs) during the Extension Period [ Time Frame: Baseline of extension period (Week 28) up to 12 months ]
  3. Incidence of specific clinical laboratory abnormalities including but not limited to anemia, neutropenia, thrombocytopenia, lymphopenia, changes in lipid profile, and liver function tests (LFTs) during the Extension Period [ Time Frame: Baseline of extension period (Week 28) up to 12 months ]
  4. Indicence of TEAE during the cross over extension perod [ Time Frame: baseline of cross over extension, 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects achieving a 30% improvement in SALT (SALT 30) at Week 24 [ Time Frame: 24 weeks ]
    overall assessment of severity of AA

  2. Change from baseline in Investigator Global Assessment (IGA) [ Time Frame: baseline, 32 weeks ]
    overall severity of AA

  3. Change from baseline in SALT [ Time Frame: baseline, 32 weeks ]
    overall severity of AA

  4. Proportion of subjects achieving a 30% improvement in SALT (SALT 30) [ Time Frame: 32 weeks ]
    severity of AA

  5. Proportion of subjects achieving a 50% improvement in SALT (SALT 50) [ Time Frame: 32 weeks ]
    severity of AA

  6. Percentage change in SALT from baseline to Week 24 [ Time Frame: baseline, 24 weeks ]
    severity of AA

  7. Proportion of subjects achieving a 75% improvement in SALT (SALT 75) [ Time Frame: 32 weeks ]
    severity of AA

  8. Proportion of subjects achieving a 100% improvement in SALT (SALT 100) [ Time Frame: 32 weeks ]
    severity of AA

  9. Incidence of treatment emergent adverse events (AEs) up to Week 24 [ Time Frame: Day 1 to Week 24 ]
  10. Incidence of specific clinical laboratory abnormalities including but not limited to anemia, neutropenia, thrombocytopenia, lymphopenia, changes in lipid profile, and liver function tests (LFTs) up to Week 24 [ Time Frame: Day 1 to week 24 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
  • Must have moderate to severe alopecia areata:

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)
  • Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.


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): NCT02974868


  Show 55 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02974868     History of Changes
Other Study ID Numbers: B7931005
2016-004048-13 ( EudraCT Number )
ALLEGRO ( Other Identifier: Alias Study Number )
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Phase 2
randomized
double-blind
placebo
alopecia areata
safety
efficacy
JAK
janus kinase
moderate
severe

Additional relevant MeSH terms:
Layout table for MeSH terms
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical