Janus Kinase Inhibition in Sarcoidosis

NCT05696795 | Completed Phase 2 FDA Drug

• 2 other identifiers: 2000033314000
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the role of the oral JAK1 inhibitor, abrocitinib 200 mg once daily, for the treatment of patients with moderate to severe cutaneous sarcoidosis.

Conditions

Sarcoidosis

Keywords

abrocitinib; JAK1 inhibitor; sarcoidosis

Outcome Measures

Primary Outcomes (1)

• Changes in Cutaneous Sarcoidosis Activity and Morphology Instrument (CASMI) score

  Improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) after 6 months of abrocitinib therapy. CSAMI is a validated clinical scoring tool for cutaneous sarcoidosis activity and severity. Scores range from 0 to 165. Higher score is worse.

  Baseline and 6 Months

Secondary Outcomes (5)

• Percent Changes in Improvement in Internal Organ Involvement

  Baseline and 6 Months

• Changes in Patient Reported Outcomes Quality of Life (King's Sarcoidosis Questionnaire)

  Baseline and 6 Months

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

  Baseline and 6 Months

• Changes in Fatigue Assessment Scale (FAS)

  Baseline and 6 Months

• Changes in Rhinosinustitis Disability Index (RSDI)

  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 sarcoidosis.

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 age 18 years old or older.
• Diagnosis of moderate to severe cutaneous sarcoidosis (CSAMI of 10 or greater) with supportive skin biopsy in which other causes of granulomas (infectious, foreign body) have been ruled out.
• Patients with either:
• Cutaneous Sarcoidosis Activity and Morphology (CSAMI) activity score greater than or equal to 10 (patients with a CSAMI greater than or equal to 10 have active cutaneous sarcoidosis involving several distinct cutaneous sites, have moderate to severe disease and would otherwise be considered candidates for systemic therapy), or
• any CSAMI score and skin involvement causing functional impairment (i.e. nasal or visual field obstruction)
• If patients are taking other systemic therapies for their sarcoidosis, they must be taking a stable dose of the other medication(s) for at least 3 months with no plans to change the regimen in the next 6 months. With the exception of methotrexate or low dose prednisone (20 mg or less per day), use of concomitant immunosuppressants, e.g. infliximab, azathioprine, etc., will not be permitted.
• Washout of topical medications will be for 2 weeks.
• Washout for oral medications will not be possible in most cases. Patients will be allowed to continue concomitant prednisone (up to 20 mg daily) or weekly methotrexate (up to 15 mg daily).
• 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).
• a) Cutaneous Sarcoidosis Activity and Morphology (CSAMI) activity score less than or equal to 10 or
• 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 as per what is reflected in their medical records.
• Patients diagnosed with Rheumatoid Arthritis (RA).
• Patients with positive tuberculin skin test or positive QuantiFERON TB test.
• Patients with significant hepatic impairment (i.e., Child Pugh C).
• Patients with moderate to severe renal impairment.
• Patients with uncontrolled peptic ulcer disease.
• Patients with advanced or untreated malignancy with the exception of treated non-melanoma skin cancer.
• Patients with a history of deep vein thrombosis and/or pulmonary embolism and/or clotting disorder.
• Patients taking immunosuppressive medications, with the exception of methotrexate (up to 20 mg weekly allowed) and/or low-dose prednisone (up to 20 mg daily allowed), 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.

Sponsors & Collaborators

• Yale University: lead
• Pfizer: collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Sarcoidosis

Interventions

abrocitinib

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Dermatology and Dermatopathology

Model Details: Male and female subjects at least 18 years of age with moderate to severe cutaneous sarcoidosis.

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 25, 2023
• Study Start: June 1, 2023
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)