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Janus Kinase Inhibition in Granuloma Annulare

Active Not RecruitingPhase 2

Sponsor: William Damsky

Conditions: Granuloma Annulare

Interventions: Abrocitinib 200 mg

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

New Haven, Connecticut, United States