Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 1:07 PM
Study NCT ID:
NCT06373458
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed 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, 28, and 36 for assessments, questionnaires and safety laboratory tests. The follow-up period will be 6 months, with clinic visits at Weeks 48 and 60.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: