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New treatment option for Chronic Spontaneous Urticaria
Official title A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
ClinicalTrials.gov ID: NCT07219615
What this study is testing
What is Ritlecitinib 50 mg?
Ritlecitinib 50 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic spontaneous urticaria.
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 chronic spontaneous urticaria (CSU) that is not effectively treated by antihistamines which are used to stop the body's "allergy alarm system" from overreacting. Chronic spontaneous urticaria is a disease that causes itchy hives and swellings in the deep layers of skin and fatty tissue just underneath the skin that come and go without a clear reason.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age:
- 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening. Disease...
- Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria: a. Chronic spontaneous urticaria diagnosis for ≥3 months at the...
You likely can't join if
- Medical Conditions:
- Medical conditions pertaining to CSU and other diseases/conditions affecting the skin
- Urticaria is solely due to inducible urticaria.
- Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to...
- Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results...
- History of severe allergic or anaphylactoid reaction to any kinase inhibitor or a known allergy/hypersensitivity to any component (including...
See the full eligibility criteria
- Age:
- 18 years of age or older (or the minimum legal adult age as defined per local regulations, whichever is greater) at screening. Disease Characteristics:
- Participants must meet the following Chronic Spontaneous Urticaria (CSU) criteria: a. Chronic spontaneous urticaria diagnosis for ≥3 months at the time of screening (with the onset date assessed by the Investigator...
- Medical Conditions:
- Medical conditions pertaining to CSU and other diseases/conditions affecting the skin
- Urticaria is solely due to inducible urticaria.
- Active dermatologic diseases (or conditions) other than chronic urticaria, with urticaria wheals or angioedema symptoms, including but not limited to urticarial vasculitis, erythema multiforme, cutaneous mastocytosis...
- Any other active skin disease associated with chronic itching that might influence, in the investigator's opinion, the study evaluations and results (eg, atopic dermatitis, bullous pemphigold, dermatitis herpetiformis...
- 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.
- General Infection History:
- Having 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.
- 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.
- Have a known immunodeficiency disorder (including positive serology for HIV at screening) or a first-degree relative with a hereditary immunodeficiency (unless known negative carrier status).
- Other Medical Conditions
- Current or recent history of clinically significant severe, progressive, or uncontrolled renal (including but not limited to active renal disease or recent kidney stones), hepatic, hematological, gastrointestinal...
- 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 Epstein-Barr Virus (EBV)-related lymphoproliferative disorder, history of lymphoma, history of leukemia, or signs and symptoms suggestive of current lymphatic...
- Significant trauma or major surgery within 1 month of the first dose of study drug or considered in imminent need for surgery. Participants with elective surgery scheduled to occur during the study can only be enrolled...
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in...
- 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 of an investigational product (drug or vaccine) within 8 weeks or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of...
- 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 electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results. 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
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Bakersfield, California, United States
- Fountain Valley, California, United States
- Lancaster, California, United States
- Pasadena, California, United States
- Colorado Springs, Colorado, United States
- River Forest, Illinois, United States
- White Marsh, Maryland, United States
- Ann Arbor, Michigan, United States
- Troy, Michigan, United States
- Oklahoma City, Oklahoma, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Sugar Land, Texas, United States
- Sofia, Sofia (stolitsa), Bulgaria
- Haskovo, Bulgaria
- Pernik, Bulgaria
- Sofia, Bulgaria
- Edmonton, Alberta, Canada
+ 41 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 8 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Bakersfield, California, United States; Fountain Valley, California, United States; Lancaster, California, United States; Pasadena, California, United States and 55 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.