A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (RESOLVE-Heart)

Kinevant Sciences

Status and phase

Terminated

Phase 2

Conditions

Sarcoidosis, Cardiac

Treatments

Drug: Namilumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05351554

KIN-1902-2002

Details and patient eligibility

About

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

Full description

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

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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