Janus Kinase Inhibition in Granuloma Annulare

NCT05650736 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2000033312No NIH funding
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Granuloma Annulare

Keywords

Granuloma Annulare; Inhibition

Outcome Measures

Primary Outcomes (1)

• Percentage Change in BSA involvement by active GA

  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).

  Baseline and 6 months

Secondary Outcomes (3)

• Changes in Granuloma Annulare Severity and Morphology Instrument (GASMI) score

  Baseline and 6 months

• Changes in Skindex-16 (Skin related quality of life index)

  Baseline and 6 months

• Changes in molecular signatures in skin and blood before and after treatment

  Baseline and 6 months

Study Arms (1)

Abrocitinib 200 mg daily

EXPERIMENTAL

6 months of treatment with abrocitinib 200 mg daily

Drug: Abrocitinib 200 mg

Interventions

Abrocitinib 200 mg DRUG

Abrocitinib (Cibinqo) is FDA approved at 200 mg dose once daily for the treatment of atopic dermatitis. It is not currently FDA approved for the treatment of GA.

Abrocitinib 200 mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• William Damsky: lead
• Yale University: collaborator
• Pfizer: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Granuloma Annulare; Inhibition, Psychological

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Necrobiotic Disorders; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• William Damsky, M.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Dermatology and Dermatopathology

Model Details: moderate to severe GA affecting at least 5% body surface area

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: October 27, 2023
• Primary Completion: May 7, 2024
• Study Completion: July 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)