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

NCT04517864 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: B79810372020-001509-21
• Study Type: interventional
• Target: 71
• Locations: 4 countries
• Sites: 38

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).

Conditions

Alopecia Areata

Keywords

alopecia totalis; alopecia universalis; hair loss; alopecia; JAK; ritlecitinib; PF-06651600; double-blind; placebo-controlled; phase 2a

Outcome Measures

Primary Outcomes (2)

• 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

  BAEP interwave I-V latency (in milliseconds) was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

  Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

• Change From Baseline in I-V Interwave Latency on BAEP at a Stimulus Intensity of 80 dB From the Left Side at Month 9

  BAEP interwave I-V latency was the primary endpoint for this study. High-intensity stimulation (80dB) was used. Participants had BAEP evaluations performed at the same evaluation center, by the same audiology professional using the same equipment, during the study. Audiology and BAEP evaluations were done on the same day, with audiology assessment first. If they could not be done on the same day, assessments had to be within 7 days of each other. A central reader was used for BAEP to confirm that locally read BAEP waves were labelled appropriately and at their peak so that latency were accurate. Central reading also ensured consistency in BAEP interpretation.

  Baseline, Month 9 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

Secondary Outcomes (34)

• Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 6

  Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

• Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Right Side at Month 9E and 15E

  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.

• Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 6

  Baseline, Month 6 (Baseline was defined as the last non-missing measurement obtained before the first dose in the placebo-controlled phase)

• Change From Baseline in I-V Interwave Latency on BAEP at 80 dB From the Left Side at Month 9E and 15E

  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.

• Change From Baseline in Percentage of Intraepidermal Nerve Fiber (IENF) With Axonal Swelling in Skin Punch Biopsies at Month 9

  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.

Study Arms (2)

Treatment Arm: PF-06651600

EXPERIMENTAL

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. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Drug: PF-06651600

Control Arm (Placebo) followed by active therapy extension

OTHER

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. After month 24, participants switch to 50 mg capsules, 1 QD, up to month 60.

Drug: Placebo

Interventions

PF-06651600 DRUG

50 mg tablet, dosed as 200 mg QD or 50 mg QD 50 mg capsule, dosed as 50 mg QD

Also known as: ritlecitinib

Treatment Arm: PF-06651600

Placebo DRUG

tablet, dosed as 4 tablets QD or 1 tablet QD

Control Arm (Placebo) followed by active therapy extension

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (38)

Marvel Clinical Research 002, LLC

Huntington Beach, California, 92647, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Skin Care Research, LLC

Boca Raton, Florida, 33486, United States

Location

Skin Care Research, LLC

Hollywood, Florida, 33021, United States

Location

Kendall Adkisson, MD - Intracoastal Dermatology

Jacksonville, Florida, 32224, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Y&L Advance Health Care Inc., d/b/a Elite Clinical Research

Miami, Florida, 33144, United States

Location

BRCR Medical Center Inc

Miramar, Florida, 33027, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Orlando, Florida, 32801, United States

Location

Orlando Dermatology & Skin Cancer Surgery Center

Oviedo, Florida, 32765, United States

Location

USF Health Morsani Center For Advanced Healthcare

Tampa, Florida, 33612, United States

Location

NorthShore University HealthSystem Dermatology Clinical Trials Unit

Skokie, Illinois, 60077, United States

Location

NorthShore University HealthSystem Dermatology Clinic

Skokie, Illinois, 60077, United States

Location

Washington University School of Medicine-Dermatology

St Louis, Missouri, 63108, United States

Location

University of New Mexico Department of Dermatology

Albuquerque, New Mexico, 87102, United States

Location

University of New Mexico Clinical & Translational Sciences Center

Albuquerque, New Mexico, 87106, United States

Location

Stony Brook Dermatology

Stony Brook, New York, 11790, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Tekton Research, Inc.

Austin, Texas, 78745, United States

Location

Center for Clinical Studies, LTD. LLP

Houston, Texas, 77004, United States

Location

Summit Clinical Research, LLC

Franklin, Virginia, 23851, United States

Location

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

Virginia Dermatology and Skin Cancer Center

Norfolk, Virginia, 23502, United States

Location

Premier Specialists Pty Ltd

Kogarah, New South Wales, 2217, Australia

Location

Eastern Health - Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Sinclair Dermatology

East Melbourne, Victoria, 3002, Australia

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1X2, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Sima Recherche

Verdun, Quebec, H4G 3E7, Canada

Location

Centre de Recherche Saint-Louis

Québec, G1W4R4, Canada

Location

Niepubliczny Zaklad Opieki Zdrowotnej Specjalistyczny Osrodek Dermatologiczny "DERMAL"

Bialystok, 15-453, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

AWP Klinika Dermatologii Pod Fortem Anna Wojas-Pelc

Krakow, 31-302, Poland

Location

Dermedic Jacek Zdybski

Ostrowiec Świętokrzyski, 27-400, Poland

Location

RCMed Oddzial Warszawa

Warsaw, 00-892, Poland

Location

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

Location

Przychodnia przy ul. Lowieckiej

Wroclaw, 50-220, Poland

Location

Centrum Medyczne Matusiak

Wroclaw, 50-566, Poland

Location

Related Publications (1)

• King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska NA, Paul C, Gong Y, Anway SD, Tran H, Wolk R, Zwillich SH, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. Am J Clin Dermatol. 2024 Mar;25(2):299-314. doi: 10.1007/s40257-024-00846-3. Epub 2024 Jan 23.

  PMID: 38263353 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alopecia Areata; Alopecia universalis; Alopecia

Interventions

PF-06651600

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: September 15, 2020
• Primary Completion: January 4, 2022
• Study Completion: May 7, 2024
• Last Updated: July 11, 2025
• Results First Posted: December 28, 2022

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CA (4); PL (8); US (23); AU (3)