Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called ritlecitinib for patients with keloids, which are raised scars that can occur after skin injuries. Keloids can be painful and itchy, and current treatments often do not work well. The researchers believe that ritlecitinib may help improve the condition by restoring balance to the immune system. The trial is currently looking for participants who are 18 years or older and have keloids that have not responded to other treatments, such as creams or injections.

Eligible participants will be divided into two groups: one group will undergo surgery to remove a keloid, while the other group will not have surgery but will still receive ritlecitinib. Throughout the study, participants will need to attend regular visits to monitor their health and response to the medication. It’s important for potential participants to know that there are specific health criteria that must be met to join, such as being in overall good health and not having certain infections or serious medical conditions. If you're interested in learning more or think you might qualify, discussing this with your healthcare provider could be a good next step.

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Eligibility criteria

• 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 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.
• Exclusion Criteria:
• • 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