Long-Term PF-06651600 for the Treatment of Alopecia Areata

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NCT04006457

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Study Location
Eastern Canada Cutaneous Research Associates Ltd.
Halifax, Nova Scotia, B3H 1Z2, Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

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1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alopecia Areata
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

-

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

-


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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Long-Term PF-06651600 for the Treatment of Alopecia Areata
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: PF-06651600
    50 mg oral tablets
  • Biological: Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine
    Single subcutaneous 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 subcutaneous injection administered to patients participating in the vaccine sub-study
Study Arms  ICMJE
  • 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 23 months.

    Patients participating in the vaccine sub-study will receive 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 21 visit of the main B7981032 study.

    Interventions:
    • 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
  • 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 24 months.

    Patients participating in the vaccine sub-study will receive 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 21 visit of the main B7981032 study.

    Interventions:
    • 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
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: September 14, 2020)		960
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)		860
Estimated Study Completion Date  ICMJE August 14, 2023
Estimated Primary Completion Date August 14, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 Center1-800-718-1021[email protected]
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  
 
Administrative Information
NCT Number  ICMJE NCT04006457
Other Study ID Numbers  ICMJE B7981032
2019-001084-71 ( EudraCT Number )
ALLEGRO LT ( 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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2021

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