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JAK3/TEC Inhibitor
Ritlecitinib for Scarring Alopecia
Phase 2
Recruiting
Led By Emma Guttman-Yassky, MD, PhD
Research Sponsored by Emma Guttman
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject self-reports a history of at least 6 months of CA (LPP/FFA or CCCA). Diagnosis will be made clinically (according to the LPPAI37, FFASI36 and/or CHLG38)
Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
Study Summary
This trial will administer a new drug to alopecia patients in order to improve hair loss. The goal is to also understand these diseases better.
Who is the study for?
Adults over 18 with scarring alopecia for at least 6 months, in good health, and not pregnant or breastfeeding can join. They must test negative for TB, agree to use effective contraception if applicable, and have no acute infections or planned surgeries. Excluded are those with certain systemic diseases causing hair loss, psychiatric conditions affecting study compliance, a history of severe allergies to drug components or recent use of immunosuppressive medications.Check my eligibility
What is being tested?
The trial is testing Ritlecitinib (PF-06651600), a new drug for cicatricial alopecia—a condition where scarred areas on the scalp cannot regrow hair. This open-label trial will involve participants providing skin and blood samples to assess their response to the treatment and understand the disease better.See study design
What are the potential side effects?
While specific side effects for Ritlecitinib in this context aren't detailed here, similar drugs may cause immune system changes leading to increased infection risk, potential liver issues reflected by lab tests changes, possible impact on blood cell counts which could affect overall energy levels or increase bleeding risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had central centrifugal cicatricial alopecia for at least 6 months.
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I am in good health overall, as confirmed by recent medical exams and tests.
Select...
I am not pregnant or breastfeeding, and if able to have children, I use effective birth control and have negative pregnancy tests.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
RNA, Messenger
Number of Treatment-Emergent Adverse Events
Severity of Treatment-Emergent Adverse Events
Secondary outcome measures
RNA, Messenger
RNA, Messenger
Fibrosis
+1 moreSide effects data
From 2022 Phase 2 trial • 460 Patients • NCT044136177%
SARS-CoV-2 test positive
5%
Urinary tract infection
4%
Nausea
4%
Headache
3%
Nasopharyngitis
3%
Arthralgia
3%
Rheumatoid arthritis
1%
Coronavirus infection
1%
Skin squamous cell carcinoma recurrent
1%
Uterine leiomyoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 11mg MR
PF-06651600 100mg
PF-06650833 400mg MR
PF-06650833 400mg MR + Tofacitinib 11mg MR
PF-06650833 400mg MR + PF-06651600 100mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: PF-06651600 (Ritlecitinib)Experimental Treatment1 Intervention
200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06651600
2019
Completed Phase 2
~1900
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,824 Total Patients Enrolled
Emma GuttmanLead Sponsor
3 Previous Clinical Trials
140 Total Patients Enrolled
Emma Guttman-Yassky, MD, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken part in any drug trials within the last 4 weeks or 5 half-lives of the drug.I have had alopecia for over 7 years, have severe scarring, or am losing hair very quickly.I do not have active hepatitis B, C, or HIV.I have had central centrifugal cicatricial alopecia for at least 6 months.I am not pregnant or breastfeeding, and if able to have children, I use effective birth control and have negative pregnancy tests.I have no current cancers except for treated skin cancer or cervical pre-cancer.You've had a test for tuberculosis that came back negative in the past year.My hair loss cause is unknown or due to multiple factors like pregnancy, medication, or hormonal changes.I am in good health overall, as confirmed by recent medical exams and tests.I haven't taken antibiotics or antivirals for infections in the last 4 weeks.I need surgery soon or have it scheduled during the study period.You have answered "yes" to questions 4 and/or 5 on a suicide rating scale at the second visit.I do not have any scalp conditions like psoriasis or dermatitis.I do not have any diseases like lupus or thyroid issues that cause hair loss.I have a history of large, raised scars on my scalp.I have not had major surgery or significant trauma in the last month.I haven't had a serious infection requiring hospital stay or IV antibiotics in the last 6 months.I am 18 years old or older.I have a history of diseases related to lymph nodes or blood cancer.I have had blood clots or inherited blood clotting disorders.You have certain abnormal results in your blood tests, kidney function, liver function, or ECG, or have certain medical conditions that may affect your safety or the study results. This includes specific blood cell counts, kidney function, liver function, recent vaccinations, recent use of certain medications, history of certain diseases, and abnormal ECG results.I have had a severe or repeated herpes infection.
Research Study Groups:
This trial has the following groups:- Group 1: PF-06651600 (Ritlecitinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Scarring Alopecia Patient Testimony for trial: Trial Name: NCT05549934 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are we aiming to learn from this research?
"The primary objective of this clinical trial is to measure the severity of treatment-emergent adverse events over a period of 48 weeks. Secondary objectives include measuring the lichen planopilaris activity index, changes in mRNA levels of CXCR3, and change in Ct values of mRNA levels of CXCR3 at baseline and week 24."
Answered by AI
What has been the most serious outcome for patients using PF-06651600?
"PF-06651600 is still being studied in Phase 2 clinical trials, so there is not yet any data supporting its efficacy. However, there is some evidence that suggests it may be safe, and it received a score of 2."
Answered by AI
Are patients still being sought for this research?
"The clinical trial in question is not presently recruiting patients, as stated on the website clinicaltrials.gov. This particular study was first posted on September 1st, 2022 and was most recently edited on September 19th, 2022. Although this one trial has completed recruitment, there are many other medical studies currently looking for patients to participate."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
I can not go out without a wig or scarf. I'm self-conscious and tired of feeling this way when I was very confident before alopecia.
PatientReceived 2+ prior treatments
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