KeloidPhase 2NCT06373458
Ritlecitinib in Patients With Keloids or Those Undergoing Keloidectomy
A Phase 2 study testing Ritlecitinib in people with Keloid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid
- What is being tested?
- Ritlecitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sharlene Martin contact
United States1 site, 1 recruiting
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Giselle Singer, 212-241-3288, giselle.singer@mssm.edu
Sharlene Martin, 212-241-3288
About this study
Official title: A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid
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.
Read the detailed description
This study is a prospective, two-arm, open-label clinical trial to investigate efficacy and safety of ritlecitinib in patients with keloid. The study will take place at Icahn School of Medicine at Mount Sinai. The study will consist of 2 arms: a total of 20 patients receiving keloidectomy and 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. Patients will be treated with ritlecitinib 50 mg QD for 36 weeks starting at Day 1. Participants will attend clinic visits at Weeks 2, 4, 8, 12, 20, 28, and 36 for assessments, questionnaires and safety laboratory tests. The follow-up period will be 6 months, with clinic visits at Weeks 48 and 60.
- Conditions
- Keloid
- Being tested
- Ritlecitinib
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitlecitinibDrug
Ritlecitinib 50mg QD for 36 weeks starting at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving keloidectomy | Experimental | A total of 20 patients receiving keloidectomy (~50% earlobe keloidectomy cap) at Day 1 as Group 1 Receives: 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 Receives: Drug: Ritlecitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence Rate
Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy
Measured: 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.
Measured: Baseline and 9 months (Visit 9)
Secondary outcomes (6)
Change in Peak keloid tension
Efficacy of ritlecitinib measured by peak keloid tension. Peak keloid tension measures the "hardness" of the skin using an instrument called a tonometer. Full scale ranges 0-100, with higher scores indicating greater "hardness".
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Detroid Keloid Scale Score (DKS)
Efficacy of Ritlecitnib measured using Detroid Keloid Scale.
The DKS 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 scale from 0-14. Higher scores indicate greater symptom severity.
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Pain Numerical Rating Scale (Pain-NRS)
Efficacy of ritlecitinib measured by Pain-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of pain by choosing a number from 0 (no pain) to 10 (worst imaginable pain) that corresponds to the severity of that symptom, with higher scores indicating higher levels of pain.
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Itch-NRS
Efficacy of ritlecitinib measured by Itch-NRS. The NRS will range from 0 (no symptoms) to 10 (severe symptoms). Patients indicate the intensity of itch by choosing a number from 0 to 10 that corresponds to the severity of that symptom.
Scale 0-10 0 = No Itch 10 = Worst Itch Imaginable
Higher scores indicate greater itch severity.
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in PGIC (Patient Global Impression of Change)
Efficacy of ritlecitinib measured by Patient Global Impression of Change (PGIC). The PGIC will be used to assess self-reported relieving effect. It will evaluate pain from no change (score 0-1), minimally improved (score 2-3), much improved (score 4-5), and very much improved (score 6-7). Total Scale from 0-87. Higher scores indicate more favorable health outcomes.
Patients will be asked to choose ONE:
- No change (or condition has gotten worse) (1)
- Almost the same, hardly any change at all (2)
- A little better, but no noticeable change (3)
- Somewhat better, but the change has not made any real difference (4)
- Moderately better, and a slight but noticeable change (5)
- Better and a definite improvement that has made a real and worthwhile difference (6)
- A great deal better and a considerable improvement that has made all the difference (7)
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in DLQI (Dermatology Life Quality Index)
Efficacy of ritlecitinib measured by Dermatology Life Quality Index (DLQI). DLQI is a 10-item questionnaire, each question is scored from 0 to 3, giving a possible score range from 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life), thus, higher scores indicate greater impairment.
Measured: Visits 2 (Week 0) and up to visit 11 (Week 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start13 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Emma Guttman, Icahn School of Medicine at Mount Sinai
- Investigators
- Emma Guttman, MD, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373458
- Sponsor's protocol ID
- STUDY-23-01508
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be provided as aggregated data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Two-Arm, Open-Label Phase IIA Clinical Trial to Investigate Efficacy and Safety of Ritlecitinib in Patients With Keloid
- ClinicalTrials.gov ID
- NCT06373458
- Acronym / sponsor ID
- STUDY-23-01508
- Conditions
- Keloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, two-arm, open-label clinical trial to investigate efficacy and safety of ritlecitinib in patients with keloid. The study will take place at Icahn School of Medicine at Mount Sinai. The study will consist of 2 arms: a total of 20 patients receiving keloidectomy and 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. Patients will be treated with ritlecitinib 50 mg QD for 36 weeks starting at Day 1. Participants will attend clinic visits at Weeks 2, 4, 8, 12, 20, 28, and 36 for assessments, questionnaires and safety laboratory tests. The follow-up period will be 6 months, with clinic visits at Weeks 48 and 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving keloidectomy | Experimental | Drug: RitlecitinibA total of 20 patients receiving keloidectomy (~50% earlobe keloidectomy cap) at Day 1 as Group 1 |
| Participants with no keloidectomy | Experimental | Drug: RitlecitinibA 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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):
Key exclusion criteria (31 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RitlecitinibRitlecitinib 50mg QD for 36 weeks starting at Day 1 | Drug | Participants receiving keloidectomy, Participants with no keloidectomy |
Primary outcome
Recurrence Rate
Time frame: at 9 months (Visit 9)
Recurrence Rate at 9 months (Visit 9) in subjects that received keloidectomy
Change in Detroid Keloid Scale Score
Time frame: Baseline and 9 months (Visit 9)
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.
6 secondary outcomes
Change in Peak keloid tension
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Detroid Keloid Scale Score (DKS)
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Pain Numerical Rating Scale (Pain-NRS)
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in Itch-NRS
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in PGIC (Patient Global Impression of Change)
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Change in DLQI (Dermatology Life Quality Index)
Time frame: Visits 2 (Week 0) and up to visit 11 (Week 60)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Results will be provided as aggregated data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharlene Martin contact
Emma Guttman, MD, PhD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ritlecitinib in people with Keloid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giselle Singer (212-241-3288, giselle.singer@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate (time frame: at 9 months (Visit 9)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.