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

March 28, 2025 updated by: Kinevant Sciences GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
Time Frame: Baseline up to approximately 2 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Laboratory Abnormalities
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Vital Sign Abnormalities
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Change From Baseline in PET Mean Standardized Update Value (SUVmean)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Mean Change From Baseline in Total Glycosylation
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Number of Participants Hospitalized for Cardiac Events
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Cumulative Oral Steroid Use
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Modified Glucocorticoid Toxicity Index (mGTI)
Time Frame: Baseline up to approximately 2 months
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)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Number of Participants Requiring Rescue Therapy
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)
Time Frame: Baseline up to approximately 2 months
Baseline up to approximately 2 months
Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)
Time Frame: Baseline up to approximately 2 months
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)
Time Frame: Baseline up to approximately 2 months
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)
Time Frame: Baseline up to approximately 2 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kinevant Sciences GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Hayes Dansky, MD, Kinevant Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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