A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active… (NCT05351554) | Clinical Trial Compass
TerminatedPhase 2
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
Stopped: Sponsor business decision not related to safety
United States1 participantsStarted 2022-08-23
Plain-language summary
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 mo…
What they're measuring
1
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation