Tyrosine Kinase 2 (TYK2) for GA and CS

NCT06725264 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 2000038598
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoidosis; Granuloma Annulare

Outcome Measures

Primary Outcomes (2)

• 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).

  Baseline and 6 months post-treatment

• 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.

  Baseline and 6 months post-treatment

Secondary Outcomes (8)

• Changes in molecular signatures in skin before and after treatment

  Baseline and 6 months post-treatment

• Changes in molecular signatures in blood before and after treatment

  Baseline and 6 months post-treatment

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

  Baseline and 6 months post-treatment

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

  Baseline and 6 months post-treatment

• Organ involvement on whole body PET

  Baseline and 6 months post-treatment

Study Arms (2)

Granuloma Annulare

EXPERIMENTAL

Participants with GA will receive the TYK2 inhibitor deucravacitinib 6mg twice daily

Drug: Deucravacitinib

Cutaneous Sarcoidosis

EXPERIMENTAL

Participants with CS will receive the TYK2 inhibitor deucravacitinib 6mg twice daily

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

6 mg twice daily

Also known as: Sotyktu

Cutaneous Sarcoidosis; Granuloma Annulare

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Yale University: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

YCCI/Church Street Research Unit (CSRU)

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Sarcoidosis; Granuloma Annulare

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Necrobiotic Disorders; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Granuloma; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William Damsky, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)