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SarcoidosisPhase 2NCT06725264

Tyrosine Kinase 2 (TYK2) for GA and CS

A Phase 2 study testing Deucravacitinib in people with Sarcoidosis and Granuloma Annulare, run by Yale University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To investigate the role of an oral TYK2 inhibitor for the treatment of patients with moderate to severe sarcoidosis with cutaneous involvement (CSAMI score of 10 or greater) and GA (defined as a BSA involvement of at least 5%), which are difficult to treat. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcoidosis, Granuloma Annulare
What is being tested?
Deucravacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Mar 2025to Jun 2026
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 18 years old or older
  • Diagnosis of GA or cutaneous sarcoidosis with supportive skin biopsy
  • BSA involvement of at least 5% (GA) or CSAMI numerical score of at least 10 (sarcoidosis)
  • If patients are on systemic therapies or phototherapy for their GA, they must discontinue these therapies with a washout period of 4 weeks and must remain off them during the study
  • If patients are on topical therapies for their GA, they must discontinue these therapies with a washout period of 2 weeks and must remain off them during the study
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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.
  • For sarcoidosis, 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)
  • 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.
  • Patients with positive tuberculin skin test or positive QuantiFERON® TB test
  • Patients with significant hepatic impairment
  • Patients with moderate renal impairment
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  • Patients with uncontrolled peptic ulcer disease
  • Patients with a history of deep vein thrombosis and/or pulmonary embolism and/or clotting disorder
  • Patients with any history of myocardial infarction or stroke.
  • Patients taking concomitant immunosuppressive medications, with the exception of methotrexate and/or low-dose prednisone, 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
  • Patients over 50 who have the presence of cardiovascular risk factor
  • 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, ii. Absolute neutrophil count <1,000/mm3, iii. Hemoglobin levels <8 g/dL, iv. Absolute lymphocyte count <500/mm3
  • Patients who are taking clinically significant 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 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.
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • YCCI/Church Street Research Unit (CSRU)

    New Haven, Connecticut, 06519

Other trials in United States

About this study

Official title: TYK2 Inhibition in Granuloma Annulare (GA) and Cutaneous Sarcoidosis (CS): an Opportunity for Pathogenesis Directed Therapy

To investigate the role of an oral TYK2 inhibitor for the treatment of patients with moderate to severe sarcoidosis with cutaneous involvement (CSAMI score of 10 or greater) and GA (defined as a BSA involvement of at least 5%), which are difficult to treat.

Read the detailed description

Primary Objective To determine if TYK2 specific inhibition is effective in treating sarcoidosis and granuloma annulare (GA), problematic granulomatous inflammatory diseases which are difficult to treat.

Secondary Objective To determine the effect of treatment of participants' quality of life and on biomarkers of disease activity which often involves internal organ changes in sarcoidosis patients.

Being tested
Deucravacitinib
Medical subject headings
Sarcoidosis, Granuloma Annulare

What participants receive

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

  • DeucravacitinibDrug

    Also called Sotyktu

    6 mg twice daily

Study groups in NCT06725264
Study groupRoleWhat they receive
Granuloma AnnulareExperimentalParticipants with GA will receive the TYK2 inhibitor deucravacitinib 6mg twice daily
Receives: Drug: Deucravacitinib
Cutaneous SarcoidosisExperimentalParticipants with CS will receive the TYK2 inhibitor deucravacitinib 6mg twice daily
Receives: Drug: Deucravacitinib

What is being measured

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

  1. Percent change in the BSA involvement of GA

    The percent change in the BSA involvement of GA after 6 months of treatment for participants with moderate to severe GA affecting at least 5% body surface area (BSA).

    Measured: Baseline and 6 months post-treatment

  2. Percent change in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score

    The percent change in the CSAMI after 6 months of treatment. CSAMI evaluates the severity of sarcoidosis lesions in sarcoidosis participants across different body areas with separate scales for "Activity" (assessing inflammation, induration, surface changes, and area of involvement) and "Damage" (assessing post-inflammatory changes like scarring and dyspigmentation), resulting in a total Activity score ranging from 0 to 165 and a total Damage score from 0 to 22; with, higher scores indicating greater disease severity.

    Measured: Baseline and 6 months post-treatment

Secondary outcomes (8)

  1. Changes in molecular signatures in skin before and after treatment

    Changes in molecular signatures in skin at baseline vs. after 6 months of treatment. RNA-sequencing will be used to examine transcriptional profiles in this skin.

    Measured: Baseline and 6 months post-treatment

  2. Changes in molecular signatures in blood before and after treatment

    Changes in molecular signatures in blood at baseline vs. after 6 months of treatment. A high throughput proteomic assay will be used to examine molecular profiles in the blood.

    Measured: Baseline and 6 months post-treatment

  3. Changes in Skindex-16 (Skin related quality of life index)

    Changes in Skindex-16 (Skin related quality of life index) baseline vs. after 6 months of treatment. This is a 16 item validated skin related Quality of Life questionnaire which will be administered by the study team to assess how GA affects the participants quality of life. Scores range from 0-96, higher scores indicating more significant impact on quality of life.

    Measured: Baseline and 6 months post-treatment

  4. Changes in Granuloma Annulare Severity and Morphology Instrument (GASMI) score

    Changes in GASMI score baseline vs. after 6 months of treatment. The Granuloma Annulare Severity and Morphology Instrument is a clinical severity scoring tool for GA. The score is determined by the study team who will examine the participants skin to determine the severity of the GA in different anatomic areas. Scores range from 0-165 with higher score indicating a worse outcome.

    Measured: Baseline and 6 months post-treatment

  5. Organ involvement on whole body PET

    Percent change in organ involvement using whole body PET- CT imaging

    Measured: Baseline and 6 months post-treatment

  6. King's Sarcoidosis Questionnaire (KSQ)

    The KSQ is a self-administered questionnaire used to assess the health-related quality of life in patients with sarcoidosis. Total score range is from 0 to 100 with higher scores indicating better health status.

    Measured: Baseline and 6 months post-treatment

  7. Sarcoidosis Fatigue Assessment Scale (FAS)

    The FAS is a 10-item self-report questionnaire used to measure the severity of fatigue in individuals with sarcoidosis, where each item is rated on a 5-point Likert scale ranging from "never" to "always". Total score is calculated by summing up all responses with a total score range from 10 (minimal fatigue) to 50 (extreme fatigue). Higher scores indicate greater fatigue.

    Measured: Baseline and 6 months post-treatment

  8. Rhinosinusitis Disability Index (RSDI)

    The RSDI is a 30-item questionnaire used to assess the impact of rhinosinusitis on a patient's quality of life. Each question is rated on a scale from 0 ("never") to 4 ("always") with a total score ranging from 0 to 120. Higher scores indicate greater disability,

    Measured: Baseline and 6 months post-treatment

Timeline

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

  1. First posted10 Dec 2024
  2. Study startMar 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Why it stopped: Funding was rescinded.

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Male and female subjects at least 18 years of age with moderate to severe granuloma annulare or cutaneous sarcoidosis affecting at least 5%body surface area.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06725264
Sponsor's protocol ID
2000038598
Status last verified
Apr 2025
First submitted
5 Dec 2024
Last updated
29 Apr 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Deucravacitinib in people with Sarcoidosis and Granuloma Annulare, 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 19 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: withdrawn, as of the sponsor's last update on 29 Apr 2025. 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 was withdrawn before enrolling participants, so there are no results.

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?

Percent change in the BSA involvement of GA (time frame: Baseline and 6 months post-treatment). The study lists 2 primary outcomes in all. 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 NCT06725264.

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 29 Apr 2025.

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