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JAK3/TEC Inhibitor
Ritlecitinib for Scarring Alopecia
Phase 2
Waitlist Available
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)
Be older than 18 years old
Must not have
Subject has a history of CA for ≥ 7 years since their disease onset, severe fibrosing disease, or very rapid hair loss at screening (de novo patients only)
Considered in imminent need for surgery or with elective surgery scheduled to occur during the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had alopecia for over 7 years, have severe scarring, or am losing hair very quickly.
Select...
I need surgery soon or have it scheduled during the study period.
Select...
I have a history of large, raised scars on my scalp.
Select...
I have not had major surgery or significant trauma in the last month.
Select...
I have a history of diseases related to lymph nodes or blood cancer.
Select...
I have had blood clots or inherited blood clotting disorders.
Select...
I have had a severe or repeated herpes infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
RNA, Messenger
Number of Treatment-Emergent Adverse Events
Severity of Treatment-Emergent Adverse Events
Secondary study objectives
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
4,625 Previous Clinical Trials
14,284,144 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
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