Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

NCT06373458 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-23-01508
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Outcome Measures

Primary Outcomes (2)

• Recurrence Rate

  Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy

  at 9 months (Visit 9)

• Change in Detroid Keloid Scale Score

  Change from Baseline in the Detroit Keloid Scale at 9 months (visit 9) (excluding those without measurable keloids after keloidectomy). Detroit Keloid Scale is a questionnaire consisting of 3 questions that assess the clinical observation (observer keloid assessment) and 4 questions that evaluate the 3 clinical signs of keloids and the impact of keloids on the patient's well-being (patient keloid questionnaire). Keloid Severity (Calculated from Total) 0-4 = mild; 5-9 = moderate; 10-14 = severe Total scores from 0-14, with higher scores indicate greater symptom severity.

  Baseline and 9 months (Visit 9)

Secondary Outcomes (6)

• Change in Peak keloid tension

  Visits 2 (Week 0) and up to visit 11 (Week 60)

• Change in Detroid Keloid Scale Score (DKS)

  Visits 2 (Week 0) and up to visit 11 (Week 60)

• Change in Pain Numerical Rating Scale (Pain-NRS)

  Visits 2 (Week 0) and up to visit 11 (Week 60)

• Change in Itch-NRS

  Visits 2 (Week 0) and up to visit 11 (Week 60)

• Change in PGIC (Patient Global Impression of Change)

  Visits 2 (Week 0) and up to visit 11 (Week 60)

Study Arms (2)

Participants receiving keloidectomy

EXPERIMENTAL

A total of 20 patients receiving keloidectomy (\~50% earlobe keloidectomy cap) at Day 1 as Group 1

Drug: Ritlecitinib

Participants with no keloidectomy

EXPERIMENTAL

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

Drug: Ritlecitinib

Interventions

Ritlecitinib DRUG

Ritlecitinib 50mg QD for 36 weeks starting at Day 1

Participants receiving keloidectomy; Participants with no keloidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who do not receive keloidectomy at Day 1/ Baseline only (Group 2):
• Patient has a minimum of either one keloid measuring ≥3 cm in length, or multiple keloids, each measuring ≥1 cm in length , which failed prior minimally invasive treatments for keloids including topicals and intralesional corticosteroid injections. However, at least one keloid should not have been treated with surgery, cryotherapy, radiation, or any other procedure that leads to a deformity that interferes with proper clinical assessments.
• Patient reports either Pain-NRS ≥4 , Itch-NRS ≥4, or DLQI ≥8both at Visit 1 (Screening) and Visit 2 (Baseline)
• Patient is judged to be in otherwise good overall health as judged by the investigator, based on medical history, physical examination, and laboratory testing. (NOTE: The definition of good health means a patient does not have uncontrolled significant co-morbid conditions).
• Ability to take oral medication without crushing, dissolving or chewing tablets.
• Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening and Day 1/ Baseline. While on ritlecitinib and for at least 28 days after taking the last dose of ritlecitinib, FOCBP who engage in activity in which conception is possible must use the approved contraceptive methods.

You may not qualify if:

• 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
• Patient has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular, neurological, psychiatric, immunologic, or other major uncontrolled diseases that will affect the health of the patient during the study or interfere with the interpretation of study results.
• Patient has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.
• Any gastrointestinal or metabolic condition that could interfere with the absorption of the oral medication.
• Active alcohol and/or drug abuse.
• History of thrombosis/ thromboembolic event, known coagulopathy.
• Additional skin disease that might interfere with keloid clinical assessments.
• Have hearing loss with progression over the previous 5 years, or sudden hearing loss, or middle or inner ear disease including otitis media, cholesteatoma, Meniere's disease, labyrinthitis, or other auditory condition that is considered acute, fluctuating, or progressive.
• Patient has received a live attenuated vaccine ≤ 30 days prior to study initiation.
• History of adverse systemic or allergic reactions to any component of the study drug.
• Recent surgery excluding keloidectomy within 4 weeks and keloidectomy within 6 months prior to trial initiation.
• Recent cryotherapy within 3 months, laser therapy within 3 months, or radiation or any other procedure within 6 months.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Pfizer: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Keloid

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Guttman, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselle Singer

CONTACT

212-241-3288; giselle.singer@mssm.edu

Sharlene Martin

CONTACT

1-212-241-3288

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Dermatology

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: August 13, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)