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Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

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ClinicalTrials.gov Identifier: NCT04008069
Recruitment Status : Recruiting
First Posted : July 4, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Genovese, Stanford University

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

Condition or disease Intervention/treatment Phase
Sarcoidosis Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1 Drug: Placebos Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: All subjects will all receive sarilumab 200 mg subcutaneously every two weeks for the first 16 weeks of the study. At Week 16, those patients who were able to successfully taper off of prednisone will then be assigned randomly to receive either sarilumab 200 mg subcutaneously every two weeks (study drug) or placebo subcutaneously for an additional 12 weeks.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: study doctor and personnel will not know whether you are assigned to the sarilumab group or the placebo group after Week 16.
Primary Purpose: Treatment
Official Title: A Phase II, Single-Site, Double-Blind, Placebo-Controlled Randomized Withdrawal Study Assessing the Efficacy and Safety of Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
Actual Study Start Date : September 3, 2019
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis Steroids
Drug Information available for: Sarilumab

Arm Intervention/treatment
Experimental: Study drug
sarilumab 200 mg subcutaneously every two weeks
Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1
Sarilumab vs Placebo

Placebo Comparator: placebo
placebo subcutaneously every two weeks
Drug: Placebos
Placebo




Primary Outcome Measures :
  1. flare-free survival of sarilumab-treated patients compared to placebo-treated controls [ Time Frame: 2 weeks ]
    Patients will be considered to have flared if they receive rescue medication including increased glucocorticoids, or if they discontinue the study treatment in order to start a different therapy.


Secondary Outcome Measures :
  1. Change in physician and patient assessments [ Time Frame: 2 weeks ]

    extrapulmonary physician organ severity tool (ePOST)

    Score Description:

    1. Slight
    2. Mild
    3. Moderate
    4. Moderate to severe
    5. Severe
    6. Very Severe

  2. change in FACIT-F score (fatigue scale [ Time Frame: 2 weeks ]

    FACIT-F score

    Scale:

    0: Not at all

    1. A little
    2. Somewhat
    3. Ouite a bit
    4. Very much

  3. change in prednisone dose [ Time Frame: 2 weeks ]
    prednisone dose

  4. change in pulmonary function tests (FVC) [ Time Frame: 2 weeks ]
    pulmonary function test (FVC)

  5. change in ALT [ Time Frame: 2 weeks ]
    ALT

  6. change in serum creatinine [ Time Frame: 2 weeks ]
    Serum creatinine

  7. change in the Sarcoidosis Activity and Severity Index for cutaneous sarcoidosis [ Time Frame: 2 weeks ]
    Sarcoidosis Activity and Severity Index

  8. change in size of sarcoidosis lesions [ Time Frame: 2 weeks ]
    size of sarcoidosis lesions

  9. Change in Pulmonary Function (FEV1) [ Time Frame: 2 weeks ]
    FEV1

  10. change in AST [ Time Frame: 2 weeks ]
    AST

  11. Change in Urine Protein level [ Time Frame: 2 weeks ]
    Urine protein

  12. 68/66 Joint evaluation [ Time Frame: 2 weeks ]

    Joint evaluation

    Score:

    0: Absent

    1: Present 9: Not applicable




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008069


Contacts
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Contact: Marty Covarrubias, BA 650-723-7416 mcovarru@stanford.edu
Contact: donna Adelman, MA 650-724-3121 donnaa@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Marty covarrubias, BA    650-723-7416    mcovarru@stanford.edu   
Principal Investigator: Mark Genovese, MD         
Sub-Investigator: Matthew Baker, MD         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Mark Genovese, MD Stanford University

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Responsible Party: Mark Genovese, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04008069     History of Changes
Other Study ID Numbers: 48375
First Posted: July 4, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark Genovese, Stanford University:
glucocorticoid-dependent
Additional relevant MeSH terms:
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Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs