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Trial record 1 of 1 for:    sarilumab | Sarcoidosis
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Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008069
Recruitment Status : Active, not recruiting
First Posted : July 5, 2019
Last Update Posted : January 27, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew C. Baker, Stanford University

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date January 27, 2022
Actual Study Start Date  ICMJE September 3, 2019
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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
  • 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
  • change in prednisone dose [ Time Frame: 2 weeks ]
    prednisone dose
  • change in pulmonary function tests (FVC) [ Time Frame: 2 weeks ]
    pulmonary function test (FVC)
  • change in ALT [ Time Frame: 2 weeks ]
    ALT
  • change in serum creatinine [ Time Frame: 2 weeks ]
    Serum creatinine
  • change in the Sarcoidosis Activity and Severity Index for cutaneous sarcoidosis [ Time Frame: 2 weeks ]
    Sarcoidosis Activity and Severity Index
  • change in size of sarcoidosis lesions [ Time Frame: 2 weeks ]
    size of sarcoidosis lesions
  • Change in Pulmonary Function (FEV1) [ Time Frame: 2 weeks ]
    FEV1
  • change in AST [ Time Frame: 2 weeks ]
    AST
  • Change in Urine Protein level [ Time Frame: 2 weeks ]
    Urine protein
  • 68/66 Joint evaluation [ Time Frame: 2 weeks ]
    Joint evaluation Score: 0: Absent 1: Present 9: Not applicable
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sarilumab in Patients With Glucocorticoid-Dependent Sarcoidosis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to compare the effectiveness and the safety of sarilumab in patients with glucocorticoid-dependent sarcoidosis.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Sarcoidosis
Intervention  ICMJE
  • Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1
    Sarilumab vs Placebo
  • Drug: Placebos
    Placebo
Study Arms  ICMJE
  • Experimental: Study drug
    sarilumab 200 mg subcutaneously every two weeks
    Intervention: Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1
  • Placebo Comparator: placebo
    placebo subcutaneously every two weeks
    Intervention: Drug: Placebos
Publications * Not Provided

*   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
Actual Enrollment  ICMJE
 (submitted: July 2, 2019)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2027
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT04008069
Other Study ID Numbers  ICMJE 48375
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew C. Baker, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Genovese, MD Stanford University
PRS Account Stanford University
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP