Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
ConditionKeloid
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
Qualifiers
Male or female patients ≥ 18 years of age at the time of signing the informed consent document (not more than 10% of the patients can be > 50 years of age).
Patient is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.
Patient is able to adhere to the study visit schedule and other protocol requirements.
Patients who receive keloidectomy at Day 1/ Baseline only (Group 1): Patient has minimum of one keloid measuring ≥2 cm in length on earlobe or ≥3.0 cm in length on areas) other than earlobe, which has failed prior minimally invasive treatments for keloids including topicals and intralesional corticosteroid injections and that can be surgically resected at Day 1/ Baseline.
Disqualifiers
Patient has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth parasitic infections, within 2 weeks of the Screening Visit. Any treatment of such infections must have been completed at least 2 weeks prior to the Screening Visit and no new/recurrent infections should have occurred prior to the Baseline Visit.
Patient with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e., Common Variable Immunodeficiency [CVID]), or active or untreated latent tuberculosis.
Infected with hepatitis B or C virus.
Patients who have history of single episode of disseminated herpes zoster (HZ) or disseminated herpes simplex or recurrent (> 1 episode of) localized dermatomal HZ
Trial design
Treatments tested in this trial
- Ritlecitinib
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Icahn School of Medicine at Mount Sinai
Lead sponsor
Pfizer
Collaborator
Source ClinicalTrials.gov