Clinical trial for Alopecia Areata
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?
Ritlecitinib 100 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alopecia areata.
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 purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body.
- 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
- Age:
- 18 years of age or older at screening. Adolescents (12 to \<18 years of age at screening) are also eligible for this study, but only if permitted by...
- Must meet the following alopecia areata criteria at both Screening and Baseline:
- 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.
You likely can't join if
- Medical Conditions:
- 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.
- General Infection History:
- Have a history of systemic infection requiring hospitalization or parenteral therapy (antimicrobial, antiviral, antiparasitic, antiprotozoal, or...
See the full eligibility criteria
- Age:
- 18 years of age or older at screening. Adolescents (12 to \<18 years of age at screening) are also eligible for this study, but only if permitted by the local IRB/EC and local regulatory health authority (if...
- Must meet the following alopecia areata criteria at both Screening and Baseline:
- 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.
- Medical Conditions:
- 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.
- General Infection History:
- 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. NOTE: participants may be rescreened after the...
- Evidence or history of untreated, currently treated or inadequately treated active or latent infection with Mycobacterium tuberculosis.
- Specific Viral Infection History:
- 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.
- Other Medical Conditions:
- 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. Chest imaging may be performed up to 12 weeks...
- 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.
- Adolescent participants 12 to \<18 years of age without one of the following:
- 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 medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy:
- Current or prior use of any prohibited medication(s), vaccine(s), or treatment(s) within the protocol-defined timelines. Prior/Concurrent Clinical Study Experience:
- Previous administration with an investigational drug or vaccine within 8 weeks (or longer as determined by the local requirement) or 5 half-lives (whichever is longer) before the first dose of study intervention in this...
- Any exclusionary abnormalities in laboratory values at Screening, as assessed by the study-specific laboratory and, if deemed necessary, confirmed by a single repeat.
- Screening standard 12-lead ECG that demonstrates clinically relevant abnormalities. Other Exclusion Criteria:
- 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's taking place
- Birmingham, Alabama, United States
- Hot Springs, Arkansas, United States
- Brea, California, United States
- Encinitas, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Santa Ana, California, United States
- Fairfield, Connecticut, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Tampa, 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
- Glenn Dale, Maryland, United States
- Rockville, Maryland, United States
+ 93 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 - 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?
Study sites include Birmingham, Alabama, United States; Hot Springs, Arkansas, United States; Brea, California, United States; Encinitas, California, United States; Huntington Beach, California, United States; Irvine, California, United States and 107 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.