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Long-Term PF-06651600 for the Treatment of Alopecia Areata (ALLEGRO-LT)

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ClinicalTrials.gov Identifier: NCT04006457
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:

This is a global Phase 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 alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug.

A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600.


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: PF-06651600 Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : August 27, 2024
Estimated Study Completion Date : August 27, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
Experimental: Treatment sequence 1

Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 given QD for 35 months.

Patients participating in the vaccine sub-study will receive the 2 vaccines or one of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 9 visit and prior to or on the Month 32 visit of the main B7981032 study.

Drug: PF-06651600
50 mg oral tablets

Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study

Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study

Experimental: Treatment sequence 2

Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 given QD for 36 months.

Patients participating in the vaccine sub-study will receive the 2 vaccines or 1 of the 2 vaccines at the vaccine sub-study Day 1, which will occur at a scheduled study visit on or after the Month 6 visit and prior to or on the Month 32 visit of the main B7981032 study.

Drug: PF-06651600
50 mg oral tablets

Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study

Biological: Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine
Single intramuscular injection administered to patients participating in the vaccine sub-study




Primary Outcome Measures :
  1. Number of subjects reporting treatment-emergent adverse events [ Time Frame: Baseline through Month 36 ]
  2. Number of subjects reporting serious adverse events [ Time Frame: Baseline through Month 36 ]
  3. Number of subjects reporting adverse events leading to discontinuation [ Time Frame: Baseline through Month 36 ]
  4. Number of subjects with clinically significant abnormalities in vital signs [ Time Frame: Baseline through Month 36 ]
  5. Number of subjects with clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Month 36 ]
  6. Vaccine sub-study: Percentage of subjects with a tetanus booster response [ Time Frame: Vaccine sub-study Month 1 ]
    Tetanus booster response is defined as 1) ≥4 fold rise in anti-tetanus toxoid IgG antibody concentration at Day 30 if the pre-vaccination concentration was ≤2.7 IU/mL; 2) ≥2 fold rise in anti tetanus toxoid IgG antibody if the pre-vaccination concentration was >2.7 IU/mL


Secondary Outcome Measures :
  1. Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=10 [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  2. Percentage of subjects with an absolute Severity of Alopecia Tool (SALT) Score <=20 [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  3. Change from baseline in SALT score [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  4. Percentage of subjects with a 75% improvement in SALT score from baseline [ Time Frame: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, and 36 ]
    SALT is a quantitative assessment of scalp hair loss with scores ranging from 0 (no scalp hair loss) to 100 (complete scalp hair loss).

  5. Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyebrow Assessment (EBA) score [ Time Frame: Months 1, 3, 6, 12, 18, 24, and 36 ]
    EBA is a numeric rating scale developed to characterize eyebrow hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).

  6. Percentage of subjects with at least a 2 grade improvement or a score of 3 in Eyelash Assessment (ELA) score [ Time Frame: Months 1, 3, 6, 12, 18, 24, and 36 ]
    ELA is a numeric rating scale developed to characterize eyelash hair loss. The numeric rating scale ranges from 0 (none) to 3 (normal).

  7. Patient's Global Impression of Change (PGI-C) response, defined as PGI-C score of "moderately improved" or "greatly improved" [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    PGI-C is a self administered questionnaire evaluating improvement or worsening of the participant's alopecia areata as compared to the start of the study and uses a single item, "Since the start of the study, my alopecia areata has: …", with 7 responses ranging from "greatly improved" to "greatly worsened."

  8. Change from baseline in Alopecia Areata Patient Priority Outcomes (AAPPO) domains [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    The AAPPO scale is a self administered questionnaire that measures the symptoms of AA as well as psychological and functional impacts over the past week.

  9. Change from baseline in the depression subscale score of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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.

  10. Change from baseline in the anxiety subscale score of the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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. Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of depression who achieved a "normal" subscale score indicative of an absence of depression [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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. Improvement on the Hospital Anxiety and Depression Scale (HADS) among participants with a baseline subscale score indicative of anxiety who achieved a "normal" subscale score indicative of an absence of anxiety [ Time Frame: Months 1, 3, 6, 9, 12, 18, 24, and 36 ]
    HADS is a participant rated questionnaire with 2 subscales. HADS-A assesses state of generalized anxiety; HADS-D assesses state of lost interest and diminished pleasure response. 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.

  13. Vaccine sub-study: Percentage of subjects with a meningococcal serogroup C response [ Time Frame: Vaccine sub-study Month 1 ]
    Meningococcal serogroup C response is defined as achieving ≥1:8 human serum bactericidal activity (hSBA) (in participants with undetectable pre-vaccination assay titers)

  14. Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥1.0 IU/mL [ Time Frame: Vaccine sub-study Month 1 ]
  15. Vaccine sub-study: Percentage of subjects with anti-tetanus antibody level ≥0.1 IU/mL [ Time Frame: Vaccine sub-study Month 1 ]
  16. Vaccine sub-study: Percentage of subjects with ≥4x increase in anti-tetanus antibody level from baseline [ Time Frame: Vaccine sub-study Month 1 ]
  17. Vaccine sub-study: Fold increase in anti-tetanus levels above baseline values [ Time Frame: Vaccine sub-study Month 1 ]
  18. Vaccine sub-study: Geometric mean concentrations (GMCs) of anti-tetanus antibody levels [ Time Frame: Vaccine sub-study Month 1 ]
  19. Vaccine sub-study: Percentage of subjects with ≥1:4 hSBA (in subjects with undetectable pre-vaccination assay titers) for meningococcal serogroup C [ Time Frame: Vaccine sub-study Month 1 ]
  20. Vaccine sub-study: Geometric mean titers (GMTs) of antibodies for meningococcal serogroup C [ Time Frame: Vaccine sub-study Day 1 and Month 1 ]


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-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
  • De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
  • De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
  • No evidence of terminal scalp hair regrowth within 6 months (de novo only)
  • Current episode of terminal scalp hair loss <=10 years (de novo only)

Exclusion Criteria-

For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

  • Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive
  • History of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ
  • History of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster
  • Infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to Day 1

Exclusion criteria for all participants:

- Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit


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): NCT04006457


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

Locations
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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: NCT04006457    
Other Study ID Numbers: B7981032
2019-001084-71 ( EudraCT Number )
ALLEGRO LT ( Other Identifier: Alias Study Number )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 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
Keywords provided by Pfizer:
Alopecia
Alopecia Areata
Alopecia totalis
Alopecia universalis
Hair loss
JAK inhibitor
PF-06651600
Ritlecitinib
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Vaccines
Immunologic Factors
Physiological Effects of Drugs