Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

  • STATUS
    Recruiting
  • End date
    Jul 26, 2027
  • participants needed
    15
  • sponsor
    Stanford University
Updated on 26 January 2021
corticosteroids
methotrexate
prednisone
hydroxychloroquine
azathioprine
sarilumab
antimalarials
pulmonary sarcoidosis
caseating granulomas

Summary

The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis.

Description

The purpose of this study is to compare the effectivness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis. To demonstrate that sarilumab treatment will be effective for inducing and maintaining glucocorticoid-free remission in male or female patients with biopsy proven active, glucocorticoid-dependent sarcoidosis affecting the lungs, lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes.

Details
Condition Lymphoproliferative Disorder, Sarcoidosis, Lymphoproliferative disorders, sarcoid
Treatment placebos, Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1
Clinical Study IdentifierNCT04008069
SponsorStanford University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Biopsy proven non-caseating granulomas consistent with sarcoidosis
negative infectious studies including AFB and fungal stains, and with compatible clinical and/or radiographic manifestations of sarcoidosis
Involvement of the lungs (stage II or III pulmonary sarcoidosis), lymph nodes, liver, kidneys, spleen, bone, soft tissues, skin, and/or eyes
At least one active manifestation, defined by the need for ongoing glucocorticoid treatment to control a sign or symptom of sarcoidosis, which requires treatment with prednisone (or equivalent corticosteroid) 10 mg and 60 mg daily (i.e. glucocorticoid dependence), with stable dosing for 28 days prior to baseline
patients taking a glucocorticoid other than prednisone, will be changed to prednisone at the equivalent dose and take this daily for 14 days prior to baseline
DMARDs including methotrexate, leflunomide, azathioprine, mycophenolate mofetil, and/or anti-malarials (i.e. hydroxychloroquine) permitted must be stable for 28 days prior to baseline and remain stable during follow-up

Exclusion Criteria

Stage IV pulmonary sarcoidosis
Central nervous system sarcoidosis
Cardiac sarcoidosis
Prior treatment with an anti-IL-6 therapy
Treatment with a biologic agent including rituximab, belimumab, TNF inhibitors, abatacept, or IL-17 inhibitors administered within 28 days prior to baseline (6 months for rituximab)
Treatment with cyclophosphamide within 3 months prior to baseline
Treatment with prednisone < 10 mg or > 60 mg daily
Known hypersensitivity or allergy to the study drug
History of, or current, inflammatory or autoimmune disease other than sarcoidosis which would present a safety issue or confound interpretation of the data
Prior or current history of other significant concomitant illness that, according to the investigator's judgment, would adversely affect the patient's participation in the study. These include, but are not limited to, cardiovascular (including stage III or IV cardiac failure according to the New York Heart Association classification), neurological (including demyelinating disease), active infectious diseases, or history of diverticulitis or gastrointestinal perforation
Patients currently pregnant or breast-feeding
Women of childbearing potential (WOCBP) who are unwilling to utilize adequate contraception and unwilling to not become pregnant during the full course of the study (must be willing to be tested for pregnancy). Adequate contraceptive measures include oral contraceptives (continuous use, as per prescription, for 2 or more cycles prior to screening), intrauterine devices, contraceptive sponges, condoms or diaphragms plus foam, or jelly, or surgical procedures such as bilateral tubal ligation or vasectomy in partner
Administration of a live/attenuated vaccine within 30 days
Evidence of active tuberculosis, HIV, or hepatitis B or C infection
History of cancer other than non-melanoma skin cancer
Patients with any of the following laboratory abnormalities at the screening visit: hemoglobin <8.5 g/dL, white blood cells <3000/mm3, neutrophils <2000/mm3, platelet count <150,000 cells/mm3, aspartate aminotransferase (AST) or ALT >1.5 x ULN, and/or bilirubin (total) above the upper limit of normal (unless Gilbert's disease has been determined by genetic testing and documented)
Presence of severe uncontrolled hypercholesterolemia (>350 mg/dL, 9.1 mmol/L) or hypertriglyceridemia (>500 mg/dL, 5.6 mmol/L) at screening or baseline
Patients with calculated creatinine clearance <30 mL/minute (using Cockroft-Gault formula)
History of alcohol or drug abuse within 5 years prior to the screening visit
Participation in any clinical research study evaluating another investigational drug or therapy within 5 half-lives or 60 days of first investigational medicinal product (IMP) administration, whichever is longer
Any patient who has had surgery within 4 weeks prior to the screening visit or with planned surgery during the course of the study
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