A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
NCT ID: NCT05351554
Last Updated: 2025-04-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2022-08-23
2022-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Namilumab
A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.
Namilumab
Specified dose on specified days
Interventions
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Namilumab
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide written informed consent, which includes compliance with study requirements and restrictions listed in the consent form
* History of documented sarcoidosis (must include histological confirmation, from any organ, in the subject's medical history or records)
* Meet Heart Rhythm Society Cardiac Sarcoid Diagnostic Criteria (modified)
* Female subjects must agree to use an approved highly effective birth control (BC) method
* Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception
* Body Mass Index (BMI) \<40 kg/m2 at Screening.
* Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization
Exclusion Criteria
* Known pulmonary hypertension requiring therapy
* Autoimmune disease other than sarcoidosis likely to require treatment during the subject's participation in this study
* Symptoms and/or signs of extracardiac sarcoidosis that are likely to warrant treatment in addition to that required for the subject's cardiac disease
* Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73 m2 (Modification of Diet in Renal Disease \[MDRD\] equation) or requiring renal replacement therapy
* Hemoglobin ≤9.5 g/dL
* Participation in another interventional clinical trial within 6 months prior to Screening and throughout the duration of participation in this study
* Systolic blood pressure (SBP) \<90 or \>180 mm Hg; Diastolic blood pressure (DBP) \<60 or \>110 mm Hg at Screening
* Has documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) or other approved clinical testing ≤3 months prior to randomization
* Significant valvular heart disease known or anticipated to require surgical repair or replacement during the subjects' participation in this study
* Female subjects who are pregnant or breastfeeding or intend to be, during the study
* History of severe allergic or anaphylactic reactions to therapeutic proteins or known sensitivity to namilumab or to its inactive components
* Any other acute or chronic medical condition, that in the judgment of the Investigator or Sponsor, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results, and would make the participant inappropriate for entry into this study
18 Years
ALL
Yes
Sponsors
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Kinevant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Kinevant Study Site
Palo Alto, California, United States
Kinevant Study Site
Denver, Colorado, United States
Kinevant Study Site
New Haven, Connecticut, United States
Kinevant Study Site
Gainesville, Florida, United States
Kinevant Study Site
Iowa City, Iowa, United States
Kinevant Study Site
Baltimore, Maryland, United States
Kinevant Study Site
Boston, Massachusetts, United States
Kinevant Study Site
Ann Arbor, Michigan, United States
Kinevant Study Site
New York, New York, United States
Kinevant Study Site
Cleveland, Ohio, United States
Kinevant Study Site
Portland, Oregon, United States
Kinevant Study Site
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KIN-1902-2002
Identifier Type: -
Identifier Source: org_study_id
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