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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

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).

Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: PF-06651600 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A PHASE 2a, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY INVESTIGATING THE SAFETY OF RITLECITINIB (PF-06651600) IN ADULT PARTICIPANTS WITH ALOPECIA AREATA
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : July 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Drug: PF-06651600
50 mg tablet, dosed as 200 mg QD or 50 mg QD
Other Name: ritlecitinib

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
Drug: Placebo
tablet, dosed as 4 tablets QD or 1 tablet QD




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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) ]
  2. Change from baseline in axonal dystrophy in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
  3. Change from baseline in IENFD in skin punch biopsies at Month 9 and Month 24 (15E) [ Time Frame: Baseline, Months 9, 24 (15E) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. Incidence of clinically significant abnormalities in vital signs [ Time Frame: Baseline through Month 24 (15E) ]
  8. Incidence of clinically significant abnormalities in clinical laboratory values [ Time Frame: Baseline through Month 24 (15E) ]
  9. 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) ]
  10. 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) ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04517864


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: NCT04517864    
Other Study ID Numbers: B7981037
2020-001509-21 ( EudraCT Number )
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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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 totalis
alopecia universalis
hair loss
alopecia
JAK
ritlecitinib
PF-06651600
double-blind
placebo-controlled
phase 2a
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical