Janus Kinase Inhibition in Granuloma Annulare

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: William Damsky
• Collaborators: Pfizer; Yale University
• Treatments: Abrocitinib

Criteria

Inclusion Criteria:

• Written informed consent

• Male and female patients 18 years old or older

• Diagnosis of GA with supportive skin biopsy

• BSA involvement of at least 5%

• If patients are on systemic therapies or phototherapy for their GA, they must discontinue these therapies with a washout period of 4 weeks and must remain off them during the study

• If patients are on topical therapies for their GA, they must discontinue these therapies with a washout period of 2 weeks and must remain off them during the study

• Females of childbearing potential must agree to use birth control during the study and there must be a negative pregnancy test documented prior to starting the medication.

• Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits

Exclusion Criteria:

• Age <18 years old

• Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)

• Patients known to be HIV or hepatitis B or C positive, or have an active, serious infection herpes simplex, herpes zoster, and pneumonia. This would also include localized infections.

• Patients with positive tuberculin skin test or positive QuantiFERON® Tuberculosis test

• Patients with significant hepatic impairment

• Patients with moderate renal impairment

• Patients with uncontrolled peptic ulcer disease

• Patients with a history of deep vein thrombosis and/or pulmonary embolism and/or clotting disorder

• Patients with any history of myocardial infarction or stroke.

• Patients taking concomitant immunosuppressive medications, with the exception of methotrexate and/or low-dose prednisone, including but not limited to mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors

• Women of childbearing potential who are unable or unwilling to use birth control while taking the medication

• Women who are pregnant or nursing

• Current smoker or history of any tobacco use

• Screening labs outside the normal range for parameters associated with potential risk for treatment under investigation. Including but not limited to:

i. Platelets <150,000/mm3 ii. Absolute neutrophil count <1,000/mm3 iii. Hemoglobin levels <8 g/dL iv. Absolute lymphocyte count <500/mm3

• Patients who are taking moderate to strong inhibitors of both CYP2C19 and CYP2C9, or strong CYP2C19 or CYP2C9 inducers, as well as P-gp substrate where small concentration changes may lead to serious or life-threatening toxicities.

• Patients who have received a live vaccine. Patients should wait a minimum of 2 weeks, if recently vaccinated, prior to initiating treatment and should not receive a live vaccine during treatment or 2 weeks post-treatment.

• Patients with 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