Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia

Overseen By Giselle Singer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Emma Guttman

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, Active infections, Severe diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, PF-06700841, for people with scarring alopecia, a condition where hair follicles are destroyed and cannot regrow hair. The drug blocks specific enzymes to reduce inflammation and prevent scarring. The study will also collect skin and blood samples to understand how the drug affects the disease.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications before joining. Specifically, you must not use systemic immunosuppressive medications, certain systemic agents for CA, intralesional corticosteroids, oral JAK inhibitors, or topical corticosteroids within specified periods before the baseline visit.

Research Team

Emma Guttman, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

Inclusion Criteria

People who are willing and able to comply with the study protocol.

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

You have been diagnosed with a type of hair loss called LPP/FFA or CCCA and have had it for at least 6 months. A doctor will check to confirm the diagnosis during the screening visit.

Exclusion Criteria

Donation of blood in excess of 500 mL within 8 weeks prior to Day 0

Participation in other studies involving investigational drug(s) within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to study entry and/or during study participation

You have hair loss, but the cause is unknown or you have other reasons for hair loss like pregnancy, medications, or certain medical conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational drug PF-06700841, a dual JAK1/TYK2 inhibitor, and provide skin and blood samples for biomarker analysis

48 weeks

Regular visits for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PF-06700841

Participant Groups

Group I: PF-06700841 Experimental Treatment 1 Intervention

tablets containing active drug (a combined TYK/JAK inhibitor)

Group II: Placebo Placebo Group 1 Intervention

Tablets without active ingredients

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