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New treatment option for Keloid
Official title Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
ClinicalTrials.gov ID: NCT06373458
What this study is testing
What is Ritlecitinib?
Ritlecitinib is an investigational medicine, being studied as a potential treatment for keloid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
- Patients who do not receive keloidectomy at Day 1/ Baseline only (Group 2):
You likely can't join if
- Patient has a persistent or recurring bacterial infection requiring systemic antibiotics, or clinically significant viral or fungal or helminth...
- Patient with current or history of positive human immunodeficiency virus (HIV), or congenital or acquired immunodeficiency (i.e., Common Variable...
- 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)...
- Patient has clinically significant (as determined by the investigator) renal, hepatic, hematologic, intestinal, endocrine, pulmonary, cardiovascular...
- Patient has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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 how well it works 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.