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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05351554
Recruitment Status : Terminated (Sponsor business decision not related to safety)
First Posted : April 28, 2022
Last Update Posted : March 31, 2023
Information provided by (Responsible Party):
Kinevant Sciences GmbH

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

Condition or disease Intervention/treatment Phase
Sarcoidosis, Cardiac Drug: Namilumab Drug: Placebo Drug: Open label Namilumab Phase 2

Detailed Description:

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

Participants enrolled in Cohort A will be randomized to receive namilumab, or placebo, and will also be treated with a daily dose of prednisone or equivalent, in addition to any other background Immunosuppressive therapy (IST) currently prescribed. Namilumab or placebo will be administered subcutaneously (SC) every 4 weeks through Week 30 after the initial dosing period.

Participants enrolled in Cohort B will be administered namilumab SC in an open-label fashion, and must continue their background therapy without change to any ongoing oral corticosteroid dose or ISTs.

Further details are in the protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 23, 2022
Actual Primary Completion Date : November 15, 2022
Actual Study Completion Date : December 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: Treatment Arm 1
Namilumab with prednisone, or equivalent
Drug: Namilumab
Namilumab administered subcutaneously with prednisone or equivalent

Placebo Comparator: Treatment Arm 2
Placebo with prednisone, or equivalent
Drug: Placebo
Placebo administered subcutaneously to match namilumab dosing with prednisone or equivalent

Experimental: Treatment Arm 3
Namilumab with current dose of prednisone, or equivalent
Drug: Open label Namilumab
Namilumab administered subcutaneously, with current dose of prednisone or equivalent

Primary Outcome Measures :
  1. Incidence and Severity of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation [ Time Frame: Baseline to Week 34 ]

Secondary Outcome Measures :
  1. Incidence and Magnitude of Treatment-Emergent Laboratory Abnormalities [ Time Frame: Baseline to Week 34 ]
  2. Change from Baseline in Vital Signs [ Time Frame: Baseline to Week 34 ]
    Measure of the change in participants in blood pressure (mm Hg)

  3. Change from Baseline in Vital Signs [ Time Frame: Baseline to Week 34 ]
    Measure of the change in participants heart rate (beats per minute)

  4. Change from Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline to Week 34 ]
    Measure of heart rate (beats per minute), PR Interval (mSec), and QT Interval (mSec)

  5. Mean Change from Baseline in Maximum Standardized Uptake Value (SUVmax) [ Time Frame: Baseline to Week 34 ]
    Measurement of activity in Positron Emission Tomography (PET)

  6. Cumulative Arrhythmia Burden [ Time Frame: Baseline to Week 34 ]
    Percentage of participants with clinically significant arrhythmia

  7. Hospitalization for Cardiac Events [ Time Frame: Baseline to Week 34 ]
    Percentage of participants hospitalized for cardiac events

  8. Mean Change from Baseline in Echocardiogram findings [ Time Frame: Baseline to Week 34 ]
    Percent Left Ventricular Ejection Fraction (LVEF)

  9. Mean Change from Baseline in Echocardiogram findings [ Time Frame: Baseline to Week 34 ]
    Percent Global Longitudinal Strain

  10. Cumulative Oral Steroid Use and Toxicity [ Time Frame: Baseline to Week 34 ]
    Measure of participants oral corticosteroid use and associated toxicities

  11. Mean Change from Baseline in Glycosylated Hemoglobin [ Time Frame: Baseline to Week 34 ]
  12. Proportion of subjects requiring rescue therapy (either cohort) and proportion of subjects successfully achieving steroid taper without requiring rescue therapy (Cohort A) [ Time Frame: Baseline to Week 34 ]
  13. Mean Change from Baseline in Multi-Organ Health Status Questionnaire [ Time Frame: Baseline to Week 34 ]
    Measure of Health-Related Quality of Life

  14. Mean Change from Baseline in The Fatigue Assessment Scale (FAS) [ Time Frame: Baseline to Week 34 ]
    10 item self-reported fatigue questionnaire

  15. Mean Change from Baseline in Subject Global Assessment [ Time Frame: Baseline to Week 34 ]
    A 5-point scale assessing overall perception of frequency and severity of sarcoid symptoms

  16. Assessments of Population Pharmacokinetics (PPK) [ Time Frame: Baseline to Week 34 ]
    Trough plasma concentration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05351554

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United States, California
Kinevant Study Site
Palo Alto, California, United States, 94304
United States, Colorado
Kinevant Study Site
Denver, Colorado, United States, 80206
United States, Connecticut
Kinevant Study Site
New Haven, Connecticut, United States, 06519
United States, Florida
Kinevant Study Site
Gainesville, Florida, United States, 32610
United States, Iowa
Kinevant Study Site
Iowa City, Iowa, United States, 52242
United States, Maryland
Kinevant Study Site
Baltimore, Maryland, United States, 21234
United States, Massachusetts
Kinevant Study Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Kinevant Study Site
Ann Arbor, Michigan, United States, 48109
United States, New York
Kinevant Study Site
New York, New York, United States, 10029
United States, Ohio
Kinevant Study Site
Cleveland, Ohio, United States, 44195
United States, Oregon
Kinevant Study Site
Portland, Oregon, United States, 97239
United States, South Carolina
Kinevant Study Site
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Kinevant Sciences GmbH
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Study Director: Hayes Dansky, MD Kinevant Sciences
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Responsible Party: Kinevant Sciences GmbH Identifier: NCT05351554    
Other Study ID Numbers: KIN-1902-2002
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: March 31, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases
Hypersensitivity, Delayed
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs