What side effects are associated with this type of intervention?

Common treatments for sarcoidosis include corticosteroids, methotrexate, and TNF inhibitors. Side effects of corticosteroids can include weight gain, osteoporosis, and increased risk of infections. Methotrexate may cause liver toxicity, nausea, and fatigue. TNF inhibitors can lead to increased susceptibility to infections and potential worsening of heart failure. For treatments similar to Abrocitinib, such as other JAK inhibitors, known side effects include increased risk of infections, venous thrombosis, pulmonary embolism, and potential malignancies. Patients should discuss these risks with their healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved JAK1 inhibitors for the treatment of sarcoidosis. However, immunosuppressive therapies, such as glucocorticoids, are commonly used to manage the condition. Other treatments under investigation include TNF-alpha inhibitors like infliximab, which have shown efficacy in severe cases of neurosarcoidosis. The study of Abrocitinib, a JAK1 inhibitor, represents a potential new direction in the treatment of sarcoidosis, focusing on its immunomodulatory effects.

What other types of research exist?

Promising alternatives to Abrocitinib for Sarcoidosis patients include Tofacitinib and Ruxolitinib. Tofacitinib has shown potential in treating various inflammatory conditions, including systemic sclerosis and dermatomyositis. Ruxolitinib has demonstrated efficacy in conditions like myelofibrosis and alopecia areata, indicating its potential utility in treating Sarcoidosis.

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Janus Kinase Inhibitor

Abrocitinib for Sarcoidosis

Q: What is the mechanism of action of this treatment?

The most common treatments for Sarcoidosis include immunosuppressive therapies such as glucocorticoids, methotrexate, and TNF inhibitors, which work by reducing inflammation and modulating the immune response. Glucocorticoids suppress the overall immune activity, methotrexate inhibits the metabolism of folic acid affecting immune cell proliferation, and TNF inhibitors block the action of tumor necrosis factor-alpha, a key cytokine in inflammation. JAK inhibitors like Abrocitinib target the Janus kinase pathways, which are involved in the signaling of various cytokines that drive inflammation. These treatments are crucial for Sarcoidosis patients as they help control the excessive immune response that leads to granuloma formation and organ damage.

Phase 2

Recruiting

Led By William Damsky, M.D.

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

Age <18 years old

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pill called abrocitinib for patients with moderate to severe skin sarcoidosis. The pill aims to reduce inflammation by targeting a specific protein in the immune system. Researchers hope this will improve skin lesions better than current treatments.

Who is the study for?

Adults with moderate to severe cutaneous sarcoidosis, confirmed by skin biopsy, can join this trial. They must have been on stable medication doses for 3 months if using other treatments and agree to not change these during the study. Women who can get pregnant need a negative pregnancy test and must use birth control. People with certain infections, liver or kidney issues, clotting disorders, cancer (except certain skin cancers), or taking strong drug inhibitors are excluded.

What is being tested?

The trial is testing abrocitinib 200 mg daily as an oral treatment for patients with moderate to severe cutaneous sarcoidosis. The goal is to see how effective it is in reducing symptoms of the disease when taken once every day.

What are the potential side effects?

Potential side effects of abrocitinib may include increased risk of infections due to immune system suppression, changes in blood tests like platelets or neutrophils which could indicate blood disorders, possible liver function changes and potential interactions with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with severe skin sarcoidosis, confirmed by a biopsy.

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My skin condition is severe and affects many areas, needing systemic treatment.

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My skin condition affects my nose or vision.

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I am willing to undergo skin biopsies, blood tests, and full body photos for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I have had cancer before, but it was not skin cancer that was successfully treated.

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My skin condition's severity score is 10 or less.

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I have been diagnosed with Rheumatoid Arthritis.

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My liver is not working well (severe impairment).

Select...

My kidneys do not work well.

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I have an untreated stomach ulcer.

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I have a history of blood clots, including in my veins or lungs.

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I am a woman who can have children and will not use birth control while on the medication.

Select...

I am not pregnant or nursing.

Select...

I am not on medications that strongly affect my body's drug processing enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Changes in Fatigue Assessment Scale (FAS)

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

Changes in Rhinosinustitis Disability Index (RSDI)

+2 more

Side effects data

From 2021 Phase 3 trial • 727 Patients • NCT04345367

19%

Nausea

13%

Headache

13%

Acne

Dermatitis atopic

Blood creatine phosphokinase increased

SARS-CoV-2 test positive

COVID-19

Nasopharyngitis

Fatigue

Folliculitis

Upper respiratory tract infection

Natural killer cell count decreased

Dizziness

Vomiting

Herpes simplex

Oral herpes

Urinary tract infection

Weight increased

Epistaxis

Diarrhoea

Conjunctivitis

Herpes zoster

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Abrocitinib 200 mg QD

Dupilumab 300 mg Q2W

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Abrocitinib 200 mg dailyExperimental Treatment1 Intervention

6 months of treatment with abrocitinib 200 mg daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abrocitinib 200 mg

2022

Completed Phase 3

~930

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Sarcoidosis include immunosuppressive therapies such as glucocorticoids, methotrexate, and TNF inhibitors, which work by reducing inflammation and modulating the immune response. Glucocorticoids suppress the overall immune activity, methotrexate inhibits the metabolism of folic acid affecting immune cell proliferation, and TNF inhibitors block the action of tumor necrosis factor-alpha, a key cytokine in inflammation. JAK inhibitors like Abrocitinib target the Janus kinase pathways, which are involved in the signaling of various cytokines that drive inflammation. These treatments are crucial for Sarcoidosis patients as they help control the excessive immune response that leads to granuloma formation and organ damage.