PF-06651600 for Cicatricial Alopecia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Cicatricial Alopecia+2 More
PF-06651600 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. CA leads to scarred areas, most commonly on the scalp, that cannot re-grow hair. Despite being a long-term condition, that often has significant impact on patients' well-being, available effective treatments for these diseases are lacking. In addition, the molecular abnormalities causing CA are largely unknown. The research team will be administering a new investigational drug (a JAK3/TEC inhibitor), ritlecitinib, which has shown statistically significant improvement in scalp hair loss for AA patients in a proof of concept and phase 2b/3 studies (B7981015 AA study). This is an open-label clinical trial. CA patients will be asked to provide small samples of skin and blood throughout the treatment period, to find out how they respond to the drug, and to attempt to better understand these diseases.

Eligible Conditions

  • Cicatricial Alopecia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cicatricial Alopecia

Study Objectives

3 Primary · 4 Secondary · Reporting Duration: Week 48

Baseline to Week 24
Change in Ct values of mRNA levels of CXCR3
Baseline to Week 48
Change in Ct values of mRNA levels of CCL5 gene
Ct value of mRNA levels of CXCR3
Week 24
The Lichen Planopilaris Activity Index (LPPAI)
Week 48
Number of Treatment-Emergent Adverse Events
Severity of Treatment-Emergent Adverse Events
The Frontal Fibrosis Alopecia Severity Index (FFASI)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cicatricial Alopecia

Side Effects for

PF-06651600 200 mg - 50 mg QD
12%Nasopharyngitis
9%Fatigue
8%Upper respiratory tract infection
6%Headache
6%Acne
6%Urinary tract infection
5%Pruritus
5%Back pain
3%Gastroenteritis
3%Urticaria
2%Dry skin
2%Insomnia
2%Dyspepsia
0%COVID-19
0%Hypertension
0%Hypercholesterolaemia
0%Blood creatine phosphokinase increased
0%Onychomycosis
0%Ear pain
0%Photosensitivity reaction
0%Abdominal pain
0%Anaemia
0%Influenza
0%Disseminated varicella zoster virus infection
0%Oesophageal spasm
0%Migraine
0%Neurogenic bladder
0%Spinal segmental dysfunction
0%Epistaxis
0%Cough
0%Rash
0%Diarrhoea
0%Bronchitis
0%Uterine leiomyoma
0%Folliculitis
0%Influenza like illness
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03715829) in the PF-06651600 200 mg - 50 mg QD ARM group. Side effects include: Nasopharyngitis with 12%, Fatigue with 9%, Upper respiratory tract infection with 8%, Headache with 6%, Acne with 6%.

Trial Design

1 Treatment Group

PF-06651600 (Ritlecitinib)
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: PF-06651600 · No Placebo Group · Phase 2

PF-06651600 (Ritlecitinib)
Drug
Experimental Group · 1 Intervention: PF-06651600 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06651600
2019
Completed Phase 2
~1660

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 48
Closest Location: Icahn School of Medicine at Mount Sinai · New York, NY
Photo of icahn school of medicine at mount sinai 1Photo of icahn school of medicine at mount sinai 2Photo of icahn school of medicine at mount sinai 3
1997First Recorded Clinical Trial
2 TrialsResearching Cicatricial Alopecia
529 CompletedClinical Trials

Who is running the clinical trial?

Emma GuttmanLead Sponsor
3 Previous Clinical Trials
138 Total Patients Enrolled
1 Trials studying Cicatricial Alopecia
48 Patients Enrolled for Cicatricial Alopecia
PfizerIndustry Sponsor
4,229 Previous Clinical Trials
6,666,531 Total Patients Enrolled
1 Trials studying Cicatricial Alopecia
48 Patients Enrolled for Cicatricial Alopecia
Emma Guttman-Yassky, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
88 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of any gender, age 18 years or older, at the time of informed consent at Screening.
Subjects who are willing and able to comply with the study visit schedule and comply with protocol requirements.
Subjects with a history of at least 6 months of CA must be aged 18 years or older
You are not a woman of childbearing potential (WOCBP).
You are judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.