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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kinevant Sciences GmbH
• Treatments: Antibodies, Monoclonal

Criteria

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 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 as described above and for consistent duration

• 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

• 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.