Can a JAK1 pill calm sarcoidosis inflammation?

NCT ID NCT05696795

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers at Yale University are testing whether abrocitinib, an oral JAK1 inhibitor already approved for atopic dermatitis, can reduce inflammation in people with moderate to severe cutaneous sarcoidosis. The trial enrolls adults with a confirmed skin biopsy and a CSAMI activity score of 10 or higher. Participants take abrocitinib 200 mg once daily for six months while researchers track changes in skin scores and internal organ inflammation using whole-body PET-CT scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abrocitinib, an oral JAK1 inhibitor approved for atopic dermatitis but not for sarcoidosis
What this could lead to
If it works, abrocitinib could offer an oral option for calming the inflammation that drives sarcoidosis in the skin and internal organs.
What could go wrong
This is a small Phase 2 study of 10 people, so any benefit may not hold up in larger trials. JAK inhibitors can raise the risk of infections and other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Jun 2023

Finished

Apr 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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-α 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Yale University

    New Haven, Connecticut, 06510, United States

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