Ritlecitinib for Scarring Alopecia

Overseen By Giselle Singer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emma Guttman

Must not be taking: Immunosuppressives, Corticosteroids, JAK inhibitors, others

Disqualifiers: Pregnancy, Active infections, Severe diseases, 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: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ritlecitinib (also known as Litfulo), to determine its effectiveness for scarring alopecia, a condition where hair follicles are permanently destroyed, causing hair loss and scalp scarring. The trial aims to understand the drug's impact on the condition and explore the underlying causes of scarring alopecia. Participants will take the drug for a year and provide skin and blood samples to help researchers track changes and responses to the treatment. Individuals who have had scarring alopecia for at least six months might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

Yes, you may need to stop certain medications before joining the trial. Specifically, you must not use systemic immunosuppressive medications, certain non-biologic systemic agents, intralesional corticosteroids, oral JAK inhibitors, or topical corticosteroids within specified periods before the trial starts.

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

Research has shown that ritlecitinib is generally safe for people with alopecia areata (AA) who have significant hair loss. In studies, patients using ritlecitinib experienced improvement, and the treatment was usually well-tolerated over time.

Serious side effects were not commonly reported, indicating that ritlecitinib is relatively safe. However, since individual experiences can differ, considering personal health conditions before joining a trial is important.

Overall, ritlecitinib has shown promising safety results in previous research on similar conditions. ^{1 2 3 4 5}

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

Ritlecitinib is unique because it targets the JAK3 and TYK2 enzymes, offering a new approach to treating scarring alopecia. Most current treatments for this condition, such as corticosteroids or immunosuppressants, aim to reduce inflammation but often have limited effectiveness and potential side effects. Ritlecitinib's targeted action on specific enzymes may provide more effective results with potentially fewer side effects. Researchers are excited about this treatment because it could offer a more precise and effective option for patients struggling with this challenging condition.

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

Research has shown that ritlecitinib, the investigational treatment in this trial, may help treat various types of hair loss, including scarring alopecia (CA). Studies have found that ritlecitinib can improve scalp hair loss in people with alopecia areata (AA), a similar condition, and promote hair regrowth over time. Although specific evidence for CA is limited, early results suggest ritlecitinib might be beneficial due to its effectiveness in similar conditions. Ritlecitinib blocks certain enzymes believed to cause hair loss, potentially aiding hair regrowth even in scarring types of alopecia. ^{1 3 5 6 7}

Who Is on the Research Team?

Emma Guttman-Yassky

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

Adults over 18 with scarring alopecia for at least 6 months, in good health, and not pregnant or breastfeeding can join. They must test negative for TB, agree to use effective contraception if applicable, and have no acute infections or planned surgeries. Excluded are those with certain systemic diseases causing hair loss, psychiatric conditions affecting study compliance, a history of severe allergies to drug components or recent use of immunosuppressive medications.

Inclusion Criteria

Subjects who are willing and able to adhere to the study visit schedule and comply with protocol requirements

I have had central centrifugal cicatricial alopecia for at least 6 months.

I am not pregnant or breastfeeding, and if able to have children, I use effective birth control and have negative pregnancy tests.

Exclusion Criteria

I haven't taken part in any drug trials within the last 4 weeks or 5 half-lives of the drug.

I have had alopecia for over 7 years, have severe scarring, or am losing hair very quickly.

I do not have active hepatitis B, C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ritlecitinib, starting with 200 mg once-daily for 8 weeks, followed by 100 mg once daily for the remaining 40 weeks

48 weeks

Regular visits for skin and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ritlecitinib

Trial Overview The trial is testing Ritlecitinib (PF-06651600), a new drug for cicatricial alopecia—a condition where scarred areas on the scalp cannot regrow hair. This open-label trial will involve participants providing skin and blood samples to assess their response to the treatment and understand the disease better.

How Is the Trial Designed?

Group I: PF-06651600 (Ritlecitinib) Experimental Treatment 1 Intervention

200 mg once-daily for 8 weeks and then 100 mg once daily for the remaining 40 weeks

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?

Emma Guttman

Lead Sponsor

Trials

4

Recruited

190+

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

Citations

1. 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

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

Long-term safety and efficacy of ritlecitinib in adults ... In patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term treatment.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0190962224030068

Sustained hair regrowth with continued ritlecitinib treatment ... Ritlecitinib resulted in hair regrowth over 24 weeks in patients with alopecia areata; this study evaluates continued ritlecitinib treatment over 48 weeks.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06531109

Study Details | NCT06531109 | Characterization And ... Despite positive results from the ALLEGRO program, there is still lack of evidence on ritlecitinib patients' characteristics and clinical outcomes in routine ...

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

Results with LITFULO® (ritlecitinib) | Safety Info View study results and before-and-after photos of actual patients with severe alopecia areata and explore the safety and effectiveness of LITFULO® medication.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05549934

NCT05549934 | Ritlecitinib for Cicatricial Alopecia Screening 12-lead ECG that demonstrates clinically significant abnormalities requiring treatment, e.g. acute myocardial infarction, serious tachy or brady ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jdv.20526

Long‐term safety and efficacy of ritlecitinib in adults ... In patients with AA and ≥25% scalp hair loss, ritlecitinib demonstrated clinical efficacy and had an acceptable safety profile with long-term ...