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PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-2b/3)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732807
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: PF-06651600 Induction Dose Drug: PF-06651600 Maintenance Dose #1 Drug: PF-06651600 Maintenance Dose #2 Drug: PF-06651600 Maintenance Dose #3 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2018
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : March 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A
Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)

Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD

Experimental: Sequence B
Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)

Drug: PF-06651600 Maintenance Dose #2
Oral tablets taken QD

Experimental: Sequence C
Maintenance dose #1 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD

Experimental: Sequence D
Maintenance dose #2 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #2
Oral tablets taken QD

Experimental: Sequence E
Maintenance dose #3 given QD for 48 weeks
Drug: PF-06651600 Maintenance Dose #3
Oral tablets taken QD

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
Drug: PF-06651600 Induction Dose
Oral tablets taken once daily (QD)

Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD

Drug: Placebo
Oral tablets taken QD

Experimental: Sequence G
Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
Drug: PF-06651600 Maintenance Dose #1
Oral tablets taken QD

Drug: Placebo
Oral tablets taken QD




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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).

  8. 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).

  9. 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.

  10. 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.

  11. 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.

  12. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03732807


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

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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: NCT03732807     History of Changes
Other Study ID Numbers: B7981015
2018-001714-14 ( EudraCT Number )
ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 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
Keywords provided by Pfizer:
Alopecia
Alopecia totalis
Alopecia universalis
Patchy hair loss
Diffuse hair loss
Hair loss
Hair disease
PF-06651600
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical