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Trial record 1 of 1 for:    B7981037
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PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA (Allegro2a)

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ClinicalTrials.gov Identifier: NCT04517864
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 14, 2020
First Posted Date  ICMJE August 18, 2020
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE September 15, 2020
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
Change from baseline in I-V interwave latency on brainstem auditory evoked potential (BAEP) at a stimulus intensity of 80 decibels (dB) at Month 9. [ Time Frame: Baseline, Month 9 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2020)
  • Change from baseline in I-V interwave latency on BAEP at a stimulus intensity of 80dB at Months 6, 18 (aka 9E), and 24 (15E) [ Time Frame: Baseline, Months 6, 18(month 9 of active therapy extension [9E]), 24 (15E) ]
  • Change from baseline in axonal dystrophy in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
  • Change from baseline in IENFD in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
  • Change from baseline in amplitude of wave V on BAEP at a stimulus intensity of 80 dB at Months 6, 9, 18 (9E), and 24 (15E) [ Time Frame: Baseline, Months 6, 9, 18 (9E), 24 (15E) ]
  • Absence of wave V on BAEP at stimulus intensities ranging from 80dB to 40dB at Months 6, 9, 18 (9E) and 24 (15E) [ Time Frame: Baseline, Months 6, 9, 18 (9E), 24 (15E) ]
  • Incidence of treatment emergent adverse events (TEAEs), treatment-emergent serious adverse events (TESAEs), and adverse events (AEs) leading to discontinuation [ Time Frame: Baseline through Month 24 (15E) ]
  • Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Month 24 (15E) ]
  • Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Month 24 (15E) ]
  • To evaluate response to ritlecitinib measured by the Severity of Alopecia Tool (SALT) in adult participants with AA [ Time Frame: Baseline through Month 24 (15E) ]
  • To evaluate the response to ritlecitinib measured by the Patient's Global Impression of Change (PGI-C) tool in adult participants with AA [ Time Frame: Baseline through Month 24 (15E) ]
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 PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
Official Title  ICMJE A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
Brief Summary This is a global Phase 2a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ritlecitinib in adults aged 18 to ≤50 years of age with ≥25% scalp hair loss due to Alopecia Areata (AA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: PF-06651600
    50 mg tablet, dosed as 200 mg QD or 50 mg QD
    Other Name: ritlecitinib
  • Drug: Placebo
    tablet, dosed as 4 tablets QD or 1 tablet QD
Study Arms  ICMJE
  • Experimental: Treatment Arm: PF-06651600
    ritlecitinib 200 milligram (mg) once per day (QD) (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24. At Month 9, participants assigned to this treatment arm will also receive 3 tablets of placebo for 4 weeks to maintain the blind with the other arm
    Intervention: Drug: PF-06651600
  • Control Arm (Placebo) followed by active therapy extension
    matching comparator: placebo QD (4 tablets x 4 weeks then 1 tablet x 8 months) then ritlecitinib 200 mg QD (four 50 mg tablets) for 4 weeks then ritlecitinib 50 mg tablet QD through month 24
    Intervention: 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: August 14, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 15, 2023
Estimated Primary Completion Date March 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of alopecia areata, including alopecia totalis and alopecia universalis.
  • At least 25% hair loss due to alopecia areata
  • Must have normal hearing and normal brainstem auditory evoked potentials (BAEPs)
  • Must have a normal neurological exam; can have a stable unilateral median neuropathy or ulnar neuropathy
  • Signed informed consent
  • Stable regimen for other medications before and during the study

Exclusion Criteria:

  • Other significant medical conditions
  • Occupational or recreational noise exposure
  • History of peripheral neuropathy or first degree relative with a hereditary peripheral neuropathy
  • HbA1c > or = 7.5% at Screening
  • Recurrent or disseminated Herpes Zoster
  • Active or chronic infection; or infection requiring hospitalization or IV antimicrobials within 6 months
  • Active or latent (insufficiently treated) Hepatitis
  • Active or latent (insufficiently treated) TB
  • Concomitant medications associated with peripheral neurologic or hearing loss
  • Protocol specific laboratory abnormalities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (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 Australia,   Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04517864
Other Study ID Numbers  ICMJE B7981037
2020-001509-21 ( EudraCT 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 Not Provided
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 February 2021

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