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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. 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 patients' well-being, available effective treatments for these diseases are lacking. In addition, the molecular abnormalities causing CA are largely unknown. The research team will be administering a new investigational drug (a JAK3/TEC inhibitor), ritlecitinib, which has shown statistically significant improvement in scalp hair loss for AA patients in a proof of concept and phase 2b/3 studies (B7981015 AA study). This is an open-label clinical trial. CA patients will be asked to provide small samples of skin and blood throughout the treatment period, to find out how they respond to the drug, and to attempt to better understand these diseases.

Research Team

Emma Guttman-Yassky

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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