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Trial record 1 of 2 for:    NCT03732807
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PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

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ClinicalTrials.gov Identifier: NCT03732807
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE December 3, 2018
Estimated Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
Percentage of subjects achieving an absolute Severity of Alopecia Tool (SALT) Score <=10 [ Time Frame: Week 24 ]
Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03732807 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • Characterize exposure response on the percentage of subjects achieving an absolute SALT score <=10 [ Time Frame: Week 24 ]
    Exposure response will be characterized using a Bayesian three-parameter exposure response model.
  • Percentage of subjects achieving a SALT score of <=10 [ Time Frame: Weeks 4, 8, 12, 18, 28, 34, 40, and 48 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
  • Percentage of subjects achieving a 50% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
  • Percentage of subjects achieving a 75% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
  • Percentage of subjects achieving a 90% improvement in SALT score from baseline [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
  • Absolute SALT scores [ Time Frame: Baseline, Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    Severity of alopecia tool is a quantitative assessment of AA severity based on scalp hair loss.
  • Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    The eyebrow assessment (EBA) is an numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
  • Percentage of subjects achieving at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score [ Time Frame: Weeks 4, 8, 12, 18, 24, 28, 34, 40, and 48 ]
    The eyelash assessment (ELA) is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).
  • Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) scale scores [ Time Frame: Weeks 4, 8, 12, 18, 24, 34, 40, and 48 ]
    The Alopecia Areata Patient Priority Outcomes (AAPPO) scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.
  • Change from baseline in the depression scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
  • Change from baseline in the anxiety scale of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety (anxious mood, restlessness, anxious thoughts, panic attacks); HADS-D assesses state of lost interest and diminished pleasure response (lowering of hedonic tone). Each subscale comprised of 7 items with range 0 (no presence of anxiety or depression) to 3 (severe feeling of anxiety or depression). Total score 0 to 21 for each subscale; higher score indicates greater severity of anxiety and depression symptoms.
  • Change from baseline in 36 Item Short Form Health Survey version 2 Acute (SF36v2 Acute) [ Time Frame: Weeks 4, 8, 12, 24, and 48 ]
    36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (CS).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PF-06651600 for the Treatment of Alopecia Areata
Official Title  ICMJE A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
Brief Summary This is a global Phase 2b/3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: PF-06651600 Induction Dose
    Oral tablets taken once daily (QD)
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
  • Drug: PF-06651600 Maintenance Dose #2
    Oral tablets taken QD
  • Drug: PF-06651600 Maintenance Dose #3
    Oral tablets taken QD
  • Drug: Placebo
    Oral tablets taken QD
Study Arms  ICMJE
  • Experimental: Sequence A
    Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #1
  • Experimental: Sequence B
    Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #2
  • Experimental: Sequence C
    Maintenance dose #1 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #1
  • Experimental: Sequence D
    Maintenance dose #2 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #2
  • Experimental: Sequence E
    Maintenance dose #3 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #3
  • Experimental: Sequence F
    Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #1
    • Drug: Placebo
  • Experimental: Sequence G
    Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
    Interventions:
    • Drug: PF-06651600 Maintenance Dose #1
    • Drug: Placebo
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2018)
660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 28, 2021
Estimated Primary Completion Date September 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of alopecia areata with no other cause of hair loss
  • ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss ≤10 years

Exclusion Criteria:

  • Other types of alopecia or other diseases that can cause hair loss
  • Other scalp diseases that could interfere with assessment of hair loss/regrowth
  • Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
  • Any previous use of any Janus kinase (JAK) inhibitor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Chile,   China,   Colombia,   Czechia,   Germany,   Hungary,   Japan,   Korea, Republic of,   Mexico,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT03732807
Other Study ID Numbers  ICMJE B7981015
2018-001714-14 ( EudraCT Number )
ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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 December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP