Abrocitinib for Granuloma Annulare

Overseen by William Damsky, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: William Damsky

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The primary objective is to determine if JAK1 specific inhibition is effective in treating granuloma annulare (GA), a problematic inflammatory skin disease without an FDA approved treatment. The primary outcome will be the percentage change in the body surface area (BSA) involvement by GA after 6 months of treatment with abrocitinib 200 mg daily in 10 patients with moderate to severe GA affecting at least 5% body surface area (BSA).

Research Team

William Damsky, M.D.

Principal Investigator

Yale University

Eligibility Criteria

Adults over 18 with Granuloma Annulare covering at least 5% of their body, who've had a confirming skin biopsy. They must stop other GA treatments before starting the trial and agree to birth control if they can have children. Not for current or past smokers, pregnant/nursing women, those with certain infections or serious health conditions like heart attack history, uncontrolled ulcers, severe liver/kidney issues, blood disorders or clotting problems.

Inclusion Criteria

I am 18 years old or older.

Written informed consent

I am able to become pregnant and agree to use birth control and have a negative pregnancy test before starting the study medication.

Exclusion Criteria

Any medical, psychiatric, or social condition that is likely to unfavorably affect the risk-benefit of continued study participation, interfere with study compliance or confound safety or efficacy assessments

I have severe liver problems.

I am under 18 years old.

Treatment Details

Interventions

• Abrocitinib (Janus Kinase Inhibitor)

Trial Overview The trial is testing Abrocitinib 200 mg daily for six months on patients with moderate to severe Granuloma Annulare. The main goal is to see how much it reduces the affected skin area. Participants will undergo regular clinic visits and agree to procedures like skin biopsies and blood tests.

Participant Groups

Group I: Abrocitinib 200 mg daily Experimental Treatment 1 Intervention

6 months of treatment with abrocitinib 200 mg daily

Who Is Running the Clinical Trial?

William Damsky

Lead Sponsor

Trials

1

Recruited

10+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

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