RECRUITING

Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid

Quick Facts

Study Start:2024-08-13

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06373458

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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.	* 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. * Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with or without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to trial initiation. Compression garments and silicone sheets may be allowed. * Treatment with medication that might interfere with blood levels or have a major impact on the clinical readout of the study drug. This includes the following: * Patient on concomitant medications that are substrates of CYP3A4 or CYP1A2 with narrow therapeutic index where small concentration changes may lead to serious adverse reactions * Patient on concomitant medications that are strong inducers of CYP3A4 as this might cause loss of efficacy of ritlecitinib * Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, ritlecitinib) within 3 months prior to the Baseline visit. * Patient has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus, and/or topical chemotherapy on any keloid lesions within 2 weeks prior to the Baseline visit. These will be allowed during the study on areas other than keloid lesions (if applicable) but not on any keloid lesions. * Female patient who is pregnant or breast feeding * FOCBP with unwillingness or inability to use a contraception method during the time of participation in the trial (Appendix 1) * Abnormality in hematology, chemistry profiles, and ECG during screening: * Platelet count: \<75000/ mm3 * Lymphocytes: \<600/ mm3 * Absolute neutrophil count: \<1200/ mm3 * Hemoglobin: \<9.0 g/dL * ALT or AST: \>3.0xULN * eGFR: \<30 mL/min * ECG that demonstrates clinically relevant abnormalities that may affect patient safety

Inclusion Criteria

Exclusion 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 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.

* 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.
* Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with or without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to trial initiation. Compression garments and silicone sheets may be allowed.
* Treatment with medication that might interfere with blood levels or have a major impact on the clinical readout of the study drug. This includes the following:
* Patient on concomitant medications that are substrates of CYP3A4 or CYP1A2 with narrow therapeutic index where small concentration changes may lead to serious adverse reactions
* Patient on concomitant medications that are strong inducers of CYP3A4 as this might cause loss of efficacy of ritlecitinib
* Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, ritlecitinib) within 3 months prior to the Baseline visit.
* Patient has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus, and/or topical chemotherapy on any keloid lesions within 2 weeks prior to the Baseline visit. These will be allowed during the study on areas other than keloid lesions (if applicable) but not on any keloid lesions.
* Female patient who is pregnant or breast feeding
* FOCBP with unwillingness or inability to use a contraception method during the time of participation in the trial (Appendix 1)
* Abnormality in hematology, chemistry profiles, and ECG during screening:
* Platelet count: \<75000/ mm3
* Lymphocytes: \<600/ mm3
* Absolute neutrophil count: \<1200/ mm3
* Hemoglobin: \<9.0 g/dL
* ALT or AST: \>3.0xULN
* eGFR: \<30 mL/min
* ECG that demonstrates clinically relevant abnormalities that may affect patient safety

Contacts and Locations

Study Contact

Giselle Singer

CONTACT

212-241-3288

giselle.singer@mssm.edu

Sharlene Martin

CONTACT

1-212-241-3288

Principal Investigator

Emma Guttman, MD, PhD

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

Emma Guttman, MD, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-13

Study Completion Date2026-05

Study Record Updates

Study Start Date2024-08-13

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Keloid