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

A Randomized, Double-blind, Placebo-controlled, Phase 2a Study With an Open-label Cohort to Assess the Safety, Tolerability, and Efficacy of Namilumab in Subjects With Active Cardiac Sarcoidosis

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

Study Overview

• Status: Terminated
• Conditions: Sarcoidosis, Cardiac
• Intervention / Treatment: Drug: Namilumab

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Kinevant Study Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Kinevant Study Site
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Kinevant Study Site
  • Florida
    • Gainesville, Florida, United States, 32610
      • Kinevant Study Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Kinevant Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21234
      • Kinevant Study Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Kinevant Study Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Kinevant Study Site
  • New York
    • New York, New York, United States, 10029
      • Kinevant Study Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Kinevant Study Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Kinevant Study Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Kinevant Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Namilumab; A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.	Drug: Namilumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to approximately 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-emergent Laboratory Abnormalities		Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Vital Sign Abnormalities		Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities		Baseline up to approximately 2 months
Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)		Baseline up to approximately 2 months
Change From Baseline in PET Mean Standardized Update Value (SUVmean)		Baseline up to approximately 2 months
Mean Change From Baseline in Total Glycosylation		Baseline up to approximately 2 months
Number of Participants Hospitalized for Cardiac Events		Baseline up to approximately 2 months
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)		Baseline up to approximately 2 months
Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)		Baseline up to approximately 2 months
Cumulative Oral Steroid Use		Baseline up to approximately 2 months
Modified Glucocorticoid Toxicity Index (mGTI)	The mGTI is a composite measure of the changes in OCS toxicity measured at 3-month intervals across 11 domains and 23 items. For the purposes of this study, radiographic assessment of bone mineral density is not being performed; therefore, this item is not being assessed in the tool and the tool is termed "modified" for this study. The change in the total score is from -35 to +410 with the exclusion of bone mineral density, with minimum score representing least toxicity (better outcomes) and maximum score representing most toxicity (worse outcomes).	Baseline up to approximately 2 months
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)		Baseline up to approximately 2 months
Number of Participants Requiring Rescue Therapy		Baseline up to approximately 2 months
Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)		Baseline up to approximately 2 months
Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)	The KSQ is a modular, multi-organ health status measure for participants with sarcoidosis for use in the clinic and the evaluation of therapies. The KSQ consists of 5 modules: General health status (10 items), Lung (6 items), Medication (3 items), Skin (3 items), and Eye (7 items). Results are given as a number between 1-100 with higher numbers indicating better health.	Baseline up to approximately 2 months
Change From Baseline in Fatigue Assessment Scale (FAS)	The FAS is a 10-item self-reported fatigue questionnaire. Participants indicate their responses on a 5-point scale (from 1 never to 5 always). Total scores on the FAS can therefore range from 10 to 50, with high scores indicating more fatigue and worse outcomes.	Baseline up to approximately 2 months
Change From Baseline in Subject Global Assessment (SGA)	The SGA is a participant reported outcome instrument used to assess their overall perception of the frequency and severity of sarcoid symptoms. The SGA is a 5-point Likert scale; the participant rates how he/she feels regarding their sarcoidosis in the previous 2 weeks prior to the study visit based on the frequency and severity of their symptoms. Scores range from 1 to 5 with lower scores representing better outcomes.	Baseline up to approximately 2 months

Collaborators and Investigators

• Sponsor: Kinevant Sciences GmbH
• Investigators: Study Director: Hayes Dansky, MD, Kinevant Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): November 15, 2022
• Study Completion (Actual): December 13, 2022

Study Registration Dates

• First Submitted: April 4, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity; Lymphatic Diseases; Lymphoproliferative Disorders; Hypersensitivity, Delayed; Sarcoidosis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone; Antibodies, Monoclonal
• Other Study ID Numbers: KIN-1902-2002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No