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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation