A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid
Icahn School of Medicine at Mount Sinai
Summary
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.
Description
This study is a prospective, two-arm, open-label clinical trial to investigate efficacy and safety of ritlecitinib in patients with keloid. The study will take place at Icahn School of Medicine at Mount Sinai. The study will consist of 2 arms: a total of 20 patients receiving keloidectomy and a total of 10 patients with no keloidectomy during the study and with at least one keloid measuring ≥3 cm or multiple keloids, measuring ≥1 cm in length each. Patients will be treated with ritlecitinib 50 mg QD for 36 weeks starting at Day 1. Participants will attend clinic visits at Weeks 2, 4, 8, 12, 20…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 e…
Interventions
- DrugRitlecitinib
Ritlecitinib 50mg QD for 36 weeks starting at Day 1
Location
- Icahn School of Medicine at Mount SinaiNew York, New York