JAK1/TYK2 Inhibitor for Scarring 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, PF-06700841 (an experimental treatment), to determine its effectiveness for cicatricial alopecia (CA), a condition causing scalp scarring and permanent hair loss. The trial aims to assess the drug's efficacy and gain insights into CA. Participants will receive either the active medication or a placebo (a pill with no active ingredients) to compare effects. Individuals with active CA for at least six months and in good overall health may qualify for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in CA treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the treatment under study, PF-06700841, has been tested in other conditions and has demonstrated promising safety results. In these studies, the treatment was safe and well-tolerated by both healthy volunteers and people with psoriasis, a skin condition. Most side effects were mild to moderate, meaning they were not severe and usually manageable.

This treatment works by blocking certain proteins involved in inflammation. It has been tested in doses up to 200mg in healthy individuals and 100mg in those with psoriasis, with no major safety concerns reported.

In summary, available evidence suggests that PF-06700841 has a good safety profile based on previous studies. However, while these findings are encouraging, the current study aims to gather more information about its safety specifically for cicatricial alopecia. ^{1 2 3 4 5}

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

Researchers are excited about PF-06700841 for cicatricial alopecia because it targets specific enzymes, JAK1 and TYK2, involved in inflammation and immune response, which are not directly addressed by current treatment options. Unlike standard treatments that may include corticosteroids or immunosuppressants, this drug uses a combined TYK/JAK inhibitor, offering a new mechanism of action. This targeted approach could potentially provide a more effective and precise treatment, reducing inflammation and preventing the progression of hair loss associated with this condition.

What evidence suggests that this treatment might be an effective treatment for cicatricial alopecia?

Research has shown that PF-06700841, a type of medication, effectively treats conditions like moderate-to-severe plaque psoriasis and alopecia areata (AA). In studies, it reduced symptoms in patients with these conditions. Although cicatricial alopecia (CA) differs, the drug's success with similar skin and hair issues suggests potential benefits. Participants in this trial may receive PF-06700841, which targets specific parts of the immune system involved in inflammation and possibly hair loss. Early findings indicate it is safe and tolerable, making it a promising option for CA, though further research is needed. ^{3 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?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PF-06700841

How Is the Trial Designed?

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

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32311398/

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque ... Conclusions: PF-06700841 was generally effective and well tolerated in patients with moderate-to-severe plaque psoriasis. Copyright © 2020 The Authors.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022202X20313798

TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque ... We report results from a phase IIa study of efficacy and safety of PF-06700841, an oral TYK2/Jak1 inhibitor, in patients with moderate-to-severe plaque ...

3. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer_presents_positive_phase_2_data_in_alopecia_areata_during_late_breaker_session_at_the_27th_european_academy_of_dermatology_and_venereology_eadv_congress

Pfizer Presents Positive Phase 2 Data in Alopecia Areata ... This Phase 2a, randomized, double-blind, multicenter study evaluates the efficacy, safety, and tolerability of PF-06651600 and PF-06700841 compared to placebo.

4. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.42519

Efficacy and Safety of the TYK2/JAK1 Inhibitor Brepocitinib for ... Secondary endpoints included response rates according to the ACR50/ACR70 response criteria, 75% and 90% improvement in the Psoriasis Area and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05076006

Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia The study team's research involves administrating patients a new investigational drug (a combined TYK/JAK inhibitor) which has been shown to be safe and well ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29266308/

The Safety, Tolerability, Pharmacokinetics, and ... PF-06700841 was safe and well-tolerated up to 200mg in healthy subjects and 100mg in psoriasis patients, with mild/moderate adverse events. It showed reduced ...

7. medchemexpress.com medchemexpress.com/PF-06700841.html?srsltid=AfmBOopF9-HuVGnK5pFPivqWl_CfWCNHMgfg1RIzRSRAgp_-ImrYI300

Brepocitinib (PF-06700841) | JAK1/TYK2 Inhibitor Brepocitinib (PF-06700841) is a potent dual Janus kinase 1 (JAK1) and TYK2 inhibitor with IC 50 s of 17 nM and 23 nM, respectively.

8. evidence.nejm.org evidence.nejm.org/doi/full/10.1056/EVIDoa2300155

Brepocitinib, Zimlovisertib, and Ropsacitinib in Hidradenitis ... TYK2/JAK1 inhibitor PF-06700841 in patients with plaque psoriasis: phase IIa, randomized, double-blind, placebo-controlled trial. J Invest ...