Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis
NCT ID: NCT04064242
Last Updated: 2025-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2020-09-23
2023-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CMK389
CMK389 10 mg/kg i.v. every 4 weeks for a total of 4 doses
CMK389
single i.v. dose every 4 weeks
Placebo
Placebo i.v. every 4 weeks for a total of 4 doses
Placebo
single i.v. dose every 4 weeks
Interventions
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CMK389
single i.v. dose every 4 weeks
Placebo
single i.v. dose every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* Biopsy proven pulmonary sarcoidosis diagnosed \> 1 year prior to screening
* Scadding stage II, III or IV as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the Investigator)
* HRCT extent of fibrosis \<20% (confirmed by the central imaging reader) at screening
* Treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening.
* Co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (Note: hydroxychloroquine is allowed as background therapy but not required)
* Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
Exclusion Criteria
* Active cardiac sarcoidosis requiring treatment. Inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible.
* A known diagnosis of neurosarcoidosis
* Forced vital capacity (FVC) \<50% of predicted at screening (central read)
* Modified British Medical Research Council (mMRC) dyspnea scale ≥ 3 at screening
* Concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening
* Prior treatment with rituximab, canakinumab, anakinra, and tocilizumab
* Current use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis
* Any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
* Contraindication to FDG-PET scan investigations such as severe claustrophobia or uncontrolled diabetes
* History or current diagnosis of ECG abnormalities not due to Cardiac Sarcoidosis and indicating significant risk of safety for patients participating in the study
* A diagnosis of Lofgren's syndrome
* A history of pancreatitis
18 Years
75 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
Univ of Florida College of Medicine x
Gainesville, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
John Hopkins Asthma And Alrgy Cntr
Baltimore, Maryland, United States
Icahn School Of Med At Mount Sinai .
New York, New York, United States
East Carolina University .
Greenville, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Brno, , Czechia
Novartis Investigative Site
Olomouc, , Czechia
Novartis Investigative Site
Aarhus N, , Denmark
Novartis Investigative Site
Hellerup, , Denmark
Novartis Investigative Site
Odense C, , Denmark
Novartis Investigative Site
Heidelberg, Baden-Wurttemberg, Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Bialystok, , Poland
Novartis Investigative Site
Lodz, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Edinburgh, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on www.novctrd.com
Other Identifiers
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CCMK389X2201
Identifier Type: -
Identifier Source: org_study_id
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