SarcoidosisPhase 2NCT05696795

Janus Kinase Inhibition in Sarcoidosis

A Phase 2 study testing Abrocitinib 200 mg in people with Sarcoidosis, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sarcoidosis
What is being tested?: Abrocitinib 200 mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2023to 23 Apr 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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.

Who cannot join

Age <18 years old.
Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin).
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.

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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.
Screening labs outside the normal range for parameters associated with potential risk for treatment under investigation. Including but not limited to:
Platelets <150,000/mm3
Absolute neutrophil count <1,000/mm3
Hemoglobin levels <8 g/dL
Absolute Lymphocyte Count <300/mm3
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.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University
New Haven, Connecticut, 06510

Other trials in United States

About this study

Official title: JAK1 Inhibition in Sarcoidosis: an Opportunity for Pathogenesis Directed Therapy

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.

Read the detailed description

To determine if JAK1 specific inhibition is effective in treating sarcoidosis, an inflammatory condition that can cause disfiguring skin lesions. The only FDA approved therapy is prednisone, a nonspecific immunosuppressant. The primary outcome will be the percent change in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) after 6 months of abrocitinib 200 mg daily in 10 patients with moderate to severe cutaneous sarcoidosis.The primary objective of this study is to determine whether oral abrocitinib reduces the CSAMI (a cutaneous sarcoid clinical scoring tool) in patients with moderate to severe cutaneous sarcoidosis. The CSAMI tool was selected over other scoring metrics given the highest interrater reliability of this metric in cutaneous sarcoidosis and the ability to generate subscores for active disease versus scarring. Secondary outcomes will include percent changes in organ involvement on whole body PET-CT imaging, Patients reported outcomes 1) Sarcoidosis related quality-of-life (QoL) metric (King's Sarcoidosis Questionnaire), 2) Skin related quality of life (Skindex-16) metric, 3) sarcoidosis Fatigue Assessment Scale (FAS), and 4) Rhinosinusitis Disability Index (RSDI). Secondary outcomes will also include evaluation of molecular signatures before and during treatment. Soluble IL-2 receptor levels in plasma are the most reliable known biomarker for sarcoidosis and will be assessed at 0 and 6 months. Additional secondary outcomes will include correlative immunologic changes in skin tissue and blood as a result of treatment. Documentation of any spontaneously reported adverse events will be completed throughout the study.

Conditions: Sarcoidosis
Being tested: Abrocitinib 200 mg
Keywords: abrocitinib, JAK1 inhibitor, sarcoidosis
Medical subject headings: Sarcoidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Abrocitinib 200 mgDrug
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.

Study groups in NCT05696795
Study group	Role	What they receive
Abrocitinib 200 mg daily	Experimental	6 months of treatment with abrocitinib 200 mg daily Receives: Drug: Abrocitinib 200 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 6 Months

Secondary outcomes (5)

Percent Changes in Improvement in Internal Organ Involvement
Internal organ involvement and activity will be determined using whole-body positron emission tomography - computed tomography (PET-CT) at baseline and after 6 months of treatment. Change in active inflammation in internal organs will be assessed by calculating total lesion glycolysis (TLG) in affected internal organs. Scores range from 0 to [no upper limit]. Higher score is worse.
Measured: Baseline and 6 Months
Changes in Patient Reported Outcomes Quality of Life (King's Sarcoidosis Questionnaire)
This tool assesses overall quality of life related to sarcoidosis through a questionnaire. Scores range from 1 to 100. Higher score is better.
Measured: Baseline and 6 Months
Changes in Skin related quality of life (Skindex-16)
Skindex-16 is a validated quality of life metric which assesses the effect of diseases involving the skin on individuals' quality of life. It is assessed using a questionnaire. Scores range from 0-96. Higher score is worse.
Measured: Baseline and 6 Months
Changes in Fatigue Assessment Scale (FAS)
FAS is a validated quality of life metric which assesses the effect of sarcoidosis on fatigue / energy level. It is assessed using a questionnaire. Scores range from 0 to 50. Higher score is worse.
Measured: Baseline and 6 Months
Changes in Rhinosinustitis Disability Index (RSDI)
RSDI is a validated quality of life metric which assesses the effect sarcoidosis-related nasal sinus symptoms on quality of life. It is assessed using a questionnaire. Scores range from 0 to 120. Higher Score is worse.
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202323 Apr 2025

First posted25 Jan 2023
Study start1 Jun 2023
Primary completion23 Apr 2025
Study completion23 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SarcoidosisStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Male and female subjects at least 18 years of age with moderate to severe cutaneous sarcoidosis.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05696795
Sponsor's protocol ID: 2000033314
Other IDs: 000
Status last verified: Apr 2026
First submitted: 13 Jan 2023
Last updated: 21 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
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An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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All Sarcoidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: JAK1 Inhibition in Sarcoidosis: an Opportunity for Pathogenesis Directed Therapy
ClinicalTrials.gov ID: NCT05696795
Acronym / sponsor ID: 2000033314
Conditions: Sarcoidosis
Keywords: abrocitinib, JAK1 inhibitor, sarcoidosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Pfizer
Study start: 1 Jun 2023 (actual)
Primary completion: 23 Apr 2025 (actual)
Study completion: 23 Apr 2025 (actual)
First posted: 25 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Male and female subjects at least 18 years of age with moderate to severe cutaneous sarcoidosis.

Arm	Type	Receives
Abrocitinib 200 mg daily	Experimental	Drug: Abrocitinib 200 mg6 months of treatment with abrocitinib 200 mg daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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.

Key exclusion criteria (23 listed)

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 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Abrocitinib 200 mgAbrocitinib (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.	Drug	Abrocitinib 200 mg daily

Primary outcome

Changes in Cutaneous Sarcoidosis Activity and Morphology Instrument (CASMI) score
Time frame: Baseline and 6 Months
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.

5 secondary outcomes

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
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
Changes in Rhinosinustitis Disability Index (RSDI)
Time frame: Baseline and 6 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Sarcoidosis

RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Repurposing Tilmanocept for Cardiac Sarcoidosis
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RecruitingObservational study
Cardiac Sarcoidosis Multi-Center Prospective Cohort
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RecruitingPhase 2/3
A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William Damsky, M.D. principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abrocitinib 200 mg in people with Sarcoidosis, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Cutaneous Sarcoidosis Activity and Morphology Instrument (CASMI) score (time frame: Baseline and 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.