Alopecia Areata study: Ritlecitinib
Official title A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
ClinicalTrials.gov ID: NCT06873945
What this study is testing
What is Ritlecitinib 100 mg?
An investigational oral capsule being studied as a potential treatment for alopecia areata. It is designed to inhibit JAK3 and TEC family kinases, which are involved in immune signaling pathways.
Also referred to as PF-06651600, Litfulo.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe ritlecitinib is and how it affects hair loss when taken at 50 mg or 100 mg daily.
- Who it's for
- People age 12 or older (including teens 12‑<18) who have alopecia areata with at least 50% scalp hair loss and are not using other hair‑loss treatments.
- What's involved
- Participants take a pill once a day (either 50 mg or 100 mg in part 1, all 100 mg in part 2). They are randomly assigned to a dose, attend up to nine clinic visits, and undergo exams, blood tests, hearing tests, X‑ray, ECG (heart test), photos, and questionnaires.
- Time commitment
- The study lasts about 13 months with up to nine site visits for tests and questionnaires.
- Phase 3: a large, late-stage study
- Time commitment: about 13 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
- ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
- Current episode of hair loss ≤10 years.
You likely can't join if
- Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the...
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including...
- Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
- Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or...
- Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4...
- Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
See the full eligibility criteria
- Have a clinical diagnosis of alopecia areata with no other etiology of hair loss.
- ≥50% hair loss of the scalp, as measured by SALT, without evidence of terminal hair regrowth within the previous 6 months.
- Current episode of hair loss ≤10 years.
- Diseases or conditions other than alopecia areata which affect hair loss, including other types of alopecia, other scalp disease that may impact the alopecia areata assessment, or active systemic diseases that may cause...
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including excipients) of the study intervention.
- Any psychiatric condition including recent or active suicidal ideation or behavior that meets protocol-defined criteria.
- Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or antifungal), or as otherwise judged clinically significant by the...
- Have active acute or chronic infection requiring treatment with oral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to Day 1.
- Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
- History (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent (more than one episode of) localized, dermatomal herpes zoster.
- Infected with hepatitis B or hepatitis C viruses: all participants will undergo screening for hepatitis B and C for eligibility.
- Have hearing loss with progression over the previous 5 years, sudden hearing loss, or middle or inner ear disease such as otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that...
- Abnormal findings on the screening chest imaging (eg, chest x-ray) including, but not limited to, presence of active TB or other infections, cardiomyopathy, or malignancy.
- Have any malignancies or have a history of malignancies with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- Have a history of any lymphoproliferative disorder such as EBV-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic or lymphoid disease.
- Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery.
- Documented evidence from a health professional of having received varicella vaccination (2 doses); or
- Evidence of prior exposure to varicella zoster virus (VZV) based on serological testing (ie, a positive VZV IgG Ab result) at Screening.
- Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the...
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Brea, California, United States
- Irvine, California, United States
- Fairfield, Connecticut, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Lake Bluff, Illinois, United States
- Northbrook, Illinois, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Rockville, Maryland, United States
- Minneapolis, Minnesota, United States
- New York, New York, United States
- Bexley, Ohio, United States
- Tulsa, Oklahoma, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Webster, Texas, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 13 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Brea, California, United States; Irvine, California, United States; Fairfield, Connecticut, United States; Miami, Florida, United States; Chicago, Illinois, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.