PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA (Allegro2a)

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

Tracking Information

• First Submitted Date: August 14, 2020
• First Posted Date: August 18, 2020
• Last Update Posted Date: February 17, 2021
• Actual Study Start Date: September 15, 2020
• Estimated Primary Completion Date: March 23, 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Alopecia Areata

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 14, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 15, 2023
• Estimated Primary Completion Date: March 23, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Canada, Poland, United States

Administrative Information

• NCT Number: NCT04517864
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2021