Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare
NCT03910543
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- 18 years old or older
- Diagnosis of cutaneous sarcoidosis or granuloma annulare with supportive skin biopsies 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 and would otherwise be considered candidates for systemic therapy), or any CSAMI score and sarcoidosis involvement causing functional impairment (i.e. nasal or visual field obstruction).
- For patients with granuloma annulare, patients with 5% or greater Body Surface Area (BSA) will be enrolled.
- If patients are on other systemic therapies for their sarcoidosis or granuloma annulare, 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 and/or low dose prednisone, use of concomitant immunosuppressants, e.g. infliximab, azathioprine, etc., will not be permitted.
- 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 undergo skin biopsies, blood collection, and total body photography and comply with clinic visits
- 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 (HBV) or C (HCV) positive (prior exposure to
but clearance of HBV and HCV is acceptable for study entry as long as patient is being
monitored by hepatology)
- Patients with active tuberculosis or untreated latent tuberculosis as determined by
positive tuberculin skin test or positive QuantiFERON® Tuberculosis (TB) test and, as
necessary, chest X-ray
- Patients with significant hepatic impairment
- Patients with untreated peptic ulcer disease
- Patients taking immunosuppressive medications, with the exception of methotrexate
and/or low- dose prednisone, including but not limited to mycophenolate mofetil,
azathioprine, tacrolimus, cyclosporine, or Tumor Necrosis Factor (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. If a woman becomes pregnant during the study, she
will stop study medication and be removed from the study. She will be urged to follow
up with her Primary Care Physician or OB/GYN. The study doctors will ask to follow the
pregnancy to its outcome.
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Descriptive Information | |||||||
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Brief Title ICMJE | Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare | ||||||
Official Title ICMJE | Open-label Trial of Tofacitinib in Cutaneous Sarcoidosis and Granuloma Annulare | ||||||
Brief Summary | To investigate the ability of tofacitinib, a Janus kinase (JAK) inhibitor, to treat patients with cutaneous sarcoidosis and granuloma annulare during 6 months of therapy. | ||||||
Detailed Description | An open-label clinical trial of tofacitinib in cutaneous sarcoidosis and GA. The hypothesis is that Janus Kinase (JAK) 1/3 inhibition with tofacitinib will be effective for the treatment these two diseases. Tofacitinib will be administered at a dose of 5 mg twice daily and response to therapy will be assessed at months 1, 3, and 6 of therapy. The primary outcomes will be improvement in the Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) and Granuloma Activity Scoring Index (GASI) after 6 months of tofacitinib therapy. Secondary outcomes will include improvement in internal organ sarcoidosis (i.e. lung, cardiac) and skin related quality of life. Pre- and on treatment PET-CT scans will be performed in patients with sarcoidosis with internal organ involvement. Pre- and on treatment blood collection and skin biopsies will be performed for correlative scientific studies using RNA sequencing, immunohistochemistry (IHC), and cytokine profiling. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Intervention Model Description: open-label trial Masking: None (Open Label)Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE | Drug: Tofacitinib 5 mg twice daily
Tofacitinib will be administered at a dose of 5 mg twice daily Other Name: Xeljanz 5 mg twice daily | ||||||
Study Arms ICMJE |
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Publications * | Damsky W, Thakral D, Emeagwali N, Galan A, King B. Tofacitinib Treatment and Molecular Analysis of Cutaneous Sarcoidosis. N Engl J Med. 2018 Dec 27;379(26):2540-2546. doi: 10.1056/NEJMoa1805958. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE | 15 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | May 2021 | ||||||
Estimated Primary Completion Date | May 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03910543 | ||||||
Other Study ID Numbers ICMJE | 2000023910 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yale University | ||||||
Study Sponsor ICMJE | Yale University | ||||||
Collaborators ICMJE | Pfizer | ||||||
Investigators ICMJE |
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PRS Account | Yale University | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |