PF-06651600 for Cicatricial Alopecia
Phase-Based Progress Estimates
Effectiveness
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
Cicatricial Alopecia+2 More
PF-06651600 - DrugEligibility
18+
All Sexes
What conditions do you have?
Select
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
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
This is further along than 68% of similar trials
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
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: DrugTreatment
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
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 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.
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