Actively Recruiting
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-30
30
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
Keloids are common, benign cutaneous overgrowths that manifest clinically as raised, hypertrophic, often hyperpigmented lesions which are formed in response to dermal injury or idiopathic stimuli. Although keloids are a common disease, it's exact incidence and prevalence is not known. Despite the debilitating nature of keloids, current treatment modalities are limited in efficacy; there is no universally effective therapy available to patients. The research team hypothesize that ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.
CONDITIONS
Official Title
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older at the time of consent (no more than 10% can be older than 50 years)
- Able to understand and voluntarily sign informed consent before any study procedures
- Able to follow study visit schedule and protocol requirements
- Group 1 (keloidectomy): At least one keloid 2 cm or longer on earlobe or 3 cm or longer on other areas, failed prior minimally invasive treatments, and can be surgically removed at baseline
- Group 2 (no keloidectomy): At least one keloid 3 cm or longer, or multiple keloids each 1 cm or longer, failed prior minimally invasive treatments, with at least one keloid not treated by surgery, cryotherapy, radiation, or other deforming procedures
- Reports pain score 4 or higher, itch score 4 or higher, or Dermatology Life Quality Index (DLQI) 8 or higher at screening and baseline visits
- In generally good health without uncontrolled significant co-morbid conditions
- Able to take oral medication without crushing, dissolving, or chewing tablets
- Females of childbearing potential must have negative pregnancy test at screening and baseline and agree to use approved contraception during treatment and for 28 days after last dose
You will not qualify if you...
- Current or recent bacterial, viral, fungal, or parasitic infections requiring treatment within 2 weeks prior to screening
- Positive or history of HIV, congenital or acquired immunodeficiency, active or untreated latent tuberculosis
- Infected with hepatitis B or C viruses
- History of disseminated herpes zoster or herpes simplex infections
- Significant uncontrolled major diseases affecting health or study results
- Suspected or active lymphoproliferative disorder or malignancy within 5 years except certain treated skin and cervical cancers
- Gastrointestinal or metabolic conditions affecting oral medication absorption
- Active alcohol or drug abuse
- History of thrombosis, thromboembolic events, or known blood clotting disorders
- Other skin diseases interfering with keloid assessment
- Hearing loss with recent progression or acute ear diseases
- Received live attenuated vaccine within 30 days before study start
- History of allergic reactions to study drug components
- Recent surgeries excluding keloidectomy within 4 weeks or keloidectomy within 6 months
- Recent cryotherapy or laser therapy within 3 months, or radiation or other procedures within 6 months
- Use of systemic immunosuppressive medications or UV phototherapy within 4 weeks prior to study
- Use of medications affecting blood levels or study drug efficacy
- Use of oral JAK inhibitors within 3 months prior to baseline
- Use of topical corticosteroids, tacrolimus, pimecrolimus, or chemotherapy on keloids within 2 weeks prior to baseline
- Pregnant or breastfeeding females
- Females of childbearing potential unwilling or unable to use contraception
- Abnormal blood counts or chemistry tests, or ECG abnormalities posing safety risks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Giselle Singer
CONTACT
S
Sharlene Martin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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