Clinical trial NCT04517864: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: alopecia totalis
alopecia universalis
hair loss
alopecia
JAK
ritlecitinib
PF-06651600
double-blind
placebo-controlled
phase 2a
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Change From Baseline in I-V Interwave Latency on Brainstem Auditory Evoked Potentials (BAEP) at a Stimulus Intensity of 80 Decibels (dB) From the Right Side at Month 9
timeFrame: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9
timeFrame: Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
Secondary outcomes:
measure: Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6
timeFrame: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E
timeFrame: Baseline, Months 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.
measure: Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6
timeFrame: Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E
timeFrame: Baseline, Month 9E and 15E (Month 9/15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-controlled Phase.
measure: Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9
timeFrame: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Change From Baseline in Percentage of IENFs With Axonal Swelling in Skin Punch Biopsies at Month 15E
timeFrame: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Change From Baseline in Intraepidermal Nerve Fiber Density (IENFD) in Skin Punch Biopsies at Month 9
timeFrame: Baseline, Month 9 (Month 6 for the 2 participants who entered the Active Therapy Extension Phase at Month 6). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Change From Baseline in IENFD in Skin Punch Biopsies at Month 15E
timeFrame: Baseline, Month 15E (Month 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 6 and Month 9
timeFrame: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Right Side at Month 9E and 15E
timeFrame: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 6 and Month 9
timeFrame: Baseline, Month 6 and Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in Amplitude of Wave V on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9E and 15E
timeFrame: Baseline, Month 9E and 15E (Month 9 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase.
measure: Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side up to Month 9
timeFrame: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
measure: Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Right Side at Baseline, Month 3E, 6E, 9E and 15E
timeFrame: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
measure: Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side up to Month 9
timeFrame: Baseline, Month 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
measure: Number of Participants With Absence of Wave V on BAEP at Stimulus Intensities Ranging From 80 dB to 40 dB From Left Side at Baseline, Month 3E, 6E, 9E and 15E
timeFrame: Baseline, Month 3E, 6E, 9E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Approximately 16 months
measure: Number of Participants Who Discontinued From Study Due to Adverse Event (AEs)
timeFrame: Approximately 16 months
measure: Number of Participants Who Discontinued Study Drug Due to AE and Continued Study
timeFrame: Approximately 16 months
measure: Number of Participants With Temporary Drug Discontinuation Due to AEs
timeFrame: Approximately 16 months
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Approximately 16 months
measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Values
timeFrame: Approximately 16 months
measure: Change From Baseline in Overall Severity of Alopecia Tool (SALT) Scores up to Month 9
timeFrame: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in Overall SALT Scores at Month 3E, 6E, 9E, 12E and 15E
timeFrame: Baseline, Month 3E, 6E, 9E, 12E and 15E (Month 3, 6, 9, 12 and 15 in the Active Therapy Extension Phase). Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase.
measure: Change From Baseline in Alopecia Areata - Severity of Alopecia Tool (AA-SALT) Score up to Month 9
timeFrame: Baseline, Months 3, 6 and 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)
measure: Change From Baseline in AA-SALT Score at Month 3E, 6E, 9E, 12E and 15E
timeFrame: Baseline, Month 3E, 6E, 9E, 12E and 15E (Baseline was defined as the last non-missing measurement obtained before the first dose in the Placebo-Controlled Phase)
measure: Number of Participants With Patient's Global Impression of Change (PGI-C) Response up to Month 9
timeFrame: Months 1, 3, 6 and 9
measure: Number of Participants With PGI-C Response at 3E, 6E, 9E, 12E and 15E
timeFrame: Month 3E, 6E, 9E, 12E and 15E
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Marvel Clinical Research 002, LLC
state: California
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Boca Raton
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research, LLC
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research
state: Florida
city: Jacksonville
country: United States
facility: Kendall Adkisson, MD - Intracoastal Dermatology
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Miami
country: United States
facility: Y&L Advance Health Care Inc., d/b/a Elite Clinical Research
state: Florida
city: Miramar
country: United States
facility: BRCR Medical Center Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Oviedo
country: United States
facility: Orlando Dermatology & Skin Cancer Surgery Center
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center For Advanced Healthcare
state: Florida
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinical Trials Unit
state: Illinois
city: Skokie
country: United States
facility: NorthShore University HealthSystem Dermatology Clinic
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Dermatology
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Department of Dermatology
state: New Mexico
city: Albuquerque
country: United States
facility: University of New Mexico Clinical & Translational Sciences Center
state: New Mexico
city: Stony Brook
country: United States
facility: Stony Brook Dermatology
state: New York
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Austin
country: United States
facility: Tekton Research, Inc.
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies, LTD. LLP
state: Texas
city: Franklin
country: United States
facility: Summit Clinical Research, LLC
state: Virginia
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Kogarah
country: Australia
facility: Premier Specialists Pty Ltd
state: New South Wales
city: Box Hill
country: Australia
facility: Eastern Health - Box Hill Hospital
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Markham
country: Canada
facility: Lynderm Research Inc.
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Verdun
country: Canada
facility: Sima Recherche
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny "DERMAL"
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Krakow
country: Poland
facility: AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc
city: Ostrowiec Swietokrzyski
country: Poland
facility: Dermedic Jacek Zdybski
city: Warszawa
country: Poland
facility: RCMed Oddzial Warszawa
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o
city: Warszawa
country: Poland
facility: MTZ Clinical Research Powered by Pratia
city: Wroclaw
country: Poland
facility: Przychodnia przy ul. Lowieckiej
city: Wrocław
country: Poland
facility: Centrum Medyczne Matusiak
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: