Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy

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