Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06373458
Phase
PHASE2
Status
Recruiting
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Conditions

  • Keloid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ritlecitinib — DRUG
    Ritlecitinib 50mg QD for 36 weeks starting at Day 1

Study Details

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.

Key Dates

Start date
Aug 13, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving keloidectomy
    A total of 20 patients receiving keloidectomy (\~50% earlobe keloidectomy cap) at Day 1 as Group 1
  • Experimental: Participants with no keloidectomy
    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, as Group 2

Primary Outcome Measure

Recurrence Rate [ Time Frame: at 9 months (Visit 9) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Giselle Singer
[email protected]
212-241-3288
Sharlene Martin
212-241-3288
Emma Guttman (PRINCIPAL_INVESTIGATOR)

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