Ritlecitinib for Keloids

Overseen By Sharlene Martin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Immunosuppressives, JAK inhibitors

Disqualifiers: HIV, Hepatitis B/C, Tuberculosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 50

Duration: 36 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ritlecitinib for keloids, which are raised, often itchy or painful scars that can form after skin injuries. The goal is to determine if ritlecitinib, a medication that helps balance the immune system, can improve or reduce these keloids. The trial includes two groups: one will have their keloids surgically removed before starting ritlecitinib, and the other will not undergo surgery. Suitable candidates are adults with keloids that haven't responded well to treatments like creams or injections and who experience significant pain or itching. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial requires that you stop using certain medications before joining. Specifically, you must not use systemic immunosuppressive medications, certain oral JAK inhibitors, or medications that affect blood levels of the study drug within a specified time before the trial. Check with the trial team to see if your current medications are affected.

Is there any evidence suggesting that ritlecitinib is likely to be safe for humans?

Research has shown that ritlecitinib has been tested in other conditions and is generally safe. In a study involving individuals with alopecia areata (a condition that causes hair loss), participants taking ritlecitinib tolerated it well over time.

Data from another study included 1,628 patients, both adults and teenagers, over a total of 2,085 patient-years. This extensive testing demonstrates that ritlecitinib is generally safe.

While individual reactions can differ, these studies suggest that ritlecitinib is usually well-tolerated, with research supporting its safety in similar situations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for keloids?

Ritlecitinib is unique because it targets the Janus kinase (JAK) pathway, which is a novel approach for treating keloids. Traditional treatments like surgery, steroid injections, or laser therapy generally focus on reducing the size or appearance of keloids rather than addressing the underlying biological processes. By specifically targeting the JAK pathway, Ritlecitinib aims to interfere with the cellular mechanisms that drive keloid formation and growth, potentially offering a more effective and lasting solution. Researchers are excited about Ritlecitinib because it represents a targeted therapy that could revolutionize how we treat keloids, moving beyond symptomatic relief to modifying the disease process itself.

What evidence suggests that ritlecitinib might be an effective treatment for keloids?

This trial will evaluate the effectiveness of ritlecitinib for managing keloids. Studies have shown that ritlecitinib, a type of medication, effectively treats various skin conditions. In patients with alopecia, which causes hair loss, ritlecitinib significantly improved their condition, suggesting it might also help with scarring. Research indicates that it restores balance to the immune system, which could benefit people with keloids. Although specific data on keloids is limited, the success of ritlecitinib in treating similar conditions offers hope for its effectiveness in managing keloids. Participants in this trial will receive either ritlecitinib alone or in conjunction with a keloidectomy. ^{2 5 6 7 8}

Who Is on the Research Team?

Emma Guttman, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with keloids, which are raised, often discolored skin growths that develop at the site of an injury. Participants can either currently have keloids or be undergoing surgery to remove them (keloidectomy). The study aims to include those who need new treatment options.

Inclusion Criteria

Patient is able to adhere to the study visit schedule and other protocol requirements

I can swallow pills without needing to break them down.

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)

Exclusion Criteria

Active alcohol and/or drug abuse

I have not received a live vaccine in the last 30 days.

History of adverse systemic or allergic reactions to any component of the study drug

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ritlecitinib 50 mg QD for 36 weeks, with clinic visits for assessments, questionnaires, and safety laboratory tests

36 weeks

Visits at Weeks 2, 4, 8, 12, 20, 28, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Visits at Weeks 48 and 60

What Are the Treatments Tested in This Trial?

Interventions

• Ritlecitinib

Trial Overview The trial is testing Ritlecitinib, a medication thought to potentially treat keloids by targeting certain pathways in the immune system. Researchers believe it might help restore balance and reduce the overgrowth of scar tissue.

How Is the Trial Designed?

Group I: Participants with no keloidectomy Experimental Treatment 1 Intervention

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

Group II: Participants receiving keloidectomy Experimental Treatment 1 Intervention

A total of 20 patients receiving keloidectomy (\~50% earlobe keloidectomy cap) at Day 1 as Group 1

Ritlecitinib is already approved in European Union, United States for the following indications:

Approved in European Union as Litfulo for:

• Severe alopecia areata

Approved in United States as Litfulo for:

• Severe alopecia areata

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Ritlecitinib, a selective JAK3/TEC kinase inhibitor, has shown promising results in inducing hair regrowth in patients with alopecia areata, with significant improvement observed after 24 weeks of treatment compared to placebo.

Unlike non-selective JAK inhibitors, ritlecitinib may have a better safety profile by avoiding adverse effects associated with JAK1/JAK2 inhibition, making it a potentially safer long-term treatment option for patients with chronic alopecia areata.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata. Ramírez-Marín, HA., Tosti, A.[2022]

Ritlecitinib (LITFULOTM) is an effective treatment for severe alopecia areata, achieving a significant reduction in hair loss as measured by the Severity of Alopecia Tool (SALT) score, with 31% of participants on the 200 mg dose achieving a SALT score of ≤20 after 24 weeks.

The treatment was generally well-tolerated, with mild to moderate side effects such as headache and upper respiratory infections, indicating a favorable safety profile for patients aged 12 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LITFULOTM (Ritlecitinib) Capsules: A Janus Kinase 3 Inhibitor for the Treatment of Severe Alopecia Areata. Gupta, AK., Ravi, SP., Vincent, K., et al.[2023]

In a phase 2b-3 trial involving 718 patients with alopecia areata, ritlecitinib demonstrated significant efficacy, with response rates based on the Severity of Alopecia Tool (SALT) score showing a 29.1% higher response in the 200 mg + 50 mg group compared to placebo at week 24.

Ritlecitinib was well tolerated, with adverse events reported in 82% to 86% of patients across different dosage groups, but no deaths occurred, indicating it may be a safe treatment option for patients aged 12 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial. King, B., Zhang, X., Harcha, WG., et al.[2023]

Ritlecitinib, an oral Janus kinase inhibitor, is being developed for multiple conditions including alopecia areata and rheumatoid arthritis, with data from 12 clinical trials involving healthy participants and patients collected between 2014 and 2021.

The development of a population pharmacokinetic model for ritlecitinib involved three iterations, leading to a final model that effectively addressed clinical drug development questions and informed the product label, indicating its potential efficacy and safety in various conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Wojciechowski, J., S Purohit, V., Huh, Y., et al.[2023]

Ritlecitinib, a selective inhibitor of JAK3 and TEC kinases, was found to be generally safe and well tolerated in participants with hepatic and renal impairments, indicating its potential for use in these populations.

Innovative statistical and in silico simulation methods were successfully used to predict that patients with renal impairment would not need dose modifications for ritlecitinib, demonstrating a new approach for generating reference data in drug studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. Purohit, V., Huh, Y., Wojciechowski, J., et al.[2023]

Ritlecitinib, an oral kinase inhibitor developed by Pfizer, was approved in the USA on June 23, 2023, for treating severe alopecia areata in adults and adolescents aged 12 and older.

The drug has also received approval in Japan for intractable cases of alopecia areata and is undergoing regulatory review in the EU, UK, and China, indicating its potential as a significant treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ritlecitinib: First Approval. Blair, HA.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39846397/

Long-term safety and efficacy of ritlecitinib in adults ... At Month 24 (as observed), 73.5% and 66.4% of patients achieved SALT score ≤20 and ≤10; 82.4% had PGI-C response; 60.8% and 65.7% had EBA and ...

2. litfulo.com litfulo.com/get-to-know-litfulo/results-with-litfulo

Results with LITFULO® (ritlecitinib) | Safety Info Studies show that the safety and effectiveness of LITFULO were consistent between adults and adolescents. Individual results may vary.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05549934?cond=frontal%20fibrosing%20alop

NCT05549934 | Ritlecitinib for Cicatricial Alopecia CA leads to scarred areas, most commonly on the scalp, that cannot re-grow hair. Despite being a long-term condition, that often has significant impact on ...

4. dermatologytimes.com dermatologytimes.com/view/ritlecitinib-shows-early-efficacy-in-alopecia-subtypes

Ritlecitinib Shows Early Efficacy in Alopecia Subtypes A late-breaking EADV presentation revealed that ritlecitinib significantly improved outcomes in patients with multiple forms of scarring

5. naaf.org naaf.org/litfulo-ritlecitinib-faq-2/

LITFULO (ritlecitinib) FAQ The most common side effects (≥1%) reported for LITFULO in clinical trials through 24 weeks of treatment were headache, diarrhea, acne, rash, urticaria, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06373458

Study Details | NCT06373458 | Ritlecitinib in Patients With ... 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 ...

7. litfulo.pfizerpro.com litfulo.pfizerpro.com/safety/pooled-safety-data

Pooled Safety Data A total of 1628 adult and adolescent (12 to 17 years old) patients received LITFULO, representing 2085 patient-years of exposure.

8. mountsinai.org mountsinai.org/clinical-trials/ritlecitinib-in-patients-with-keloids-those-undergoing-keloidectomy

Ritlecitinib in Patients With Keloids or Those Undergoing ... Ritlecitinib as a JAK3/TEC inhibitor will be able to reverse both the systemic and local keloid disease process by re-establishing immune homeostasis.