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

Phase 2TerminatedNCT05351554

Kinevant Sciences GmbH1 enrolled

Overview

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

Study was terminated after a single participant had received 2 doses.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sarcoidosis, Cardiac

Interventions

NamilumabDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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.

Locations (12)

Kinevant Study Site

Palo Alto, California, United States

Kinevant Study Site

Denver, Colorado, United States

Kinevant Study Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.