Janus Kinase Inhibition in Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 26 May 2025
• Main ID: NCT05696795
• Date of registration: 13/01/2023
• Prospective Registration: Yes
• Primary sponsor: Yale University
• Public title: Janus Kinase Inhibition in Sarcoidosis
• Scientific title: JAK1 Inhibition in Sarcoidosis: an Opportunity for Pathogenesis Directed Therapy
• Date of first enrolment: June 1, 2023
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05696795
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: William Damsky, M.D.
• Affiliation: Yale University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent.

2. Male and female patients age 18 years old or older.

3. 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.

4. Patients with either:

1. 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

2. any CSAMI score and skin involvement causing functional impairment (i.e. nasal
or visual field obstruction)

5. 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.

1. Washout of topical medications will be for 2 weeks.

2. 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).

6. 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.

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

Exclusion Criteria:

1. Age <18 years old.

2. 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

3. 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.

4. Patients diagnosed with Rheumatoid Arthritis (RA).

5. Patients with positive tuberculin skin test or positive QuantiFERON TB test.

6. Patients with significant hepatic impairment (i.e., Child Pugh C).

7. Patients with moderate to severe renal impairment.

8. Patients with uncontrolled peptic ulcer disease.

9. Patients with advanced or untreated malignancy with the exception of treated
non-melanoma skin cancer.

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

11. 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-a inhibitors.

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

13. Women who are pregnant or nursing.

14. Current smoker or history of any tobacco use.

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

1. Platelets <150,000/mm3

2. Absolute neutrophil count <1,000/mm3

3. Hemoglobin levels <8 g/dL

4. Absolute Lymphocyte Count <300/mm3

16. 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.

17. 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.

18. Patients who have recently 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.


Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sarcoidosis

Intervention(s)

Drug: Abrocitinib 200 mg

Primary Outcome(s)

Changes in Cutaneous Sarcoidosis Activity and Morphology Instrument (CASMI) score [Time Frame: Baseline and 6 Months]

Secondary Outcome(s)

Changes in Rhinosinustitis Disability Index (RSDI) [Time Frame: Baseline and 6 months]

Changes in Skin related quality of life (Skindex-16) [Time Frame: Baseline and 6 Months]

Changes in Fatigue Assessment Scale (FAS) [Time Frame: Baseline and 6 Months]

Percent Changes in Improvement in Internal Organ Involvement [Time Frame: Baseline and 6 Months]

Changes in Patient Reported Outcomes Quality of Life (King's Sarcoidosis Questionnaire) [Time Frame: Baseline and 6 Months]

Secondary ID(s)

2000033314

000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer