A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis

Stopped early · Phase 2

Conditions studied: Sarcoidosis, Cardiac

In brief

A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.

Key facts

Study ID: NCT05351554
Run by: Kinevant Sciences GmbH
People needed: 1
Starts: 2022-08-23
Expected to finish: 2022-12-13
Last updated by the study team: 2025-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female age ≥18 years
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

You may not qualify if…

Hospitalized for any respiratory or cardiac illness ≤30 days prior to Screening
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
Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

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

Full record on ClinicalTrials.gov

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