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

Primary Purpose

Sarcoidosis, Cardiac

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Namilumab
Placebo
Open label Namilumab
Sponsored by
Kinevant Sciences GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoidosis, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site
  • Kinevant Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Treatment Arm 1

Treatment Arm 2

Treatment Arm 3

Arm Description

Namilumab with prednisone, or equivalent

Placebo with prednisone, or equivalent

Namilumab with current dose of prednisone, or equivalent

Outcomes

Primary Outcome Measures

Incidence and Severity of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation

Secondary Outcome Measures

Incidence and Magnitude of Treatment-Emergent Laboratory Abnormalities
Change from Baseline in Vital Signs
Measure of the change in participants in blood pressure (mm Hg)
Change from Baseline in Vital Signs
Measure of the change in participants heart rate (beats per minute)
Change from Baseline in Electrocardiogram (ECG) Parameters
Measure of heart rate (beats per minute), PR Interval (mSec), and QT Interval (mSec)
Mean Change from Baseline in Maximum Standardized Uptake Value (SUVmax)
Measurement of activity in Positron Emission Tomography (PET)
Cumulative Arrhythmia Burden
Percentage of participants with clinically significant arrhythmia
Hospitalization for Cardiac Events
Percentage of participants hospitalized for cardiac events
Mean Change from Baseline in Echocardiogram findings
Percent Left Ventricular Ejection Fraction (LVEF)
Mean Change from Baseline in Echocardiogram findings
Percent Global Longitudinal Strain
Cumulative Oral Steroid Use and Toxicity
Measure of participants oral corticosteroid use and associated toxicities
Mean Change from Baseline in Glycosylated Hemoglobin
Proportion of subjects requiring rescue therapy (either cohort) and proportion of subjects successfully achieving steroid taper without requiring rescue therapy (Cohort A)
Mean Change from Baseline in Multi-Organ Health Status Questionnaire
Measure of Health-Related Quality of Life
Mean Change from Baseline in The Fatigue Assessment Scale (FAS)
10 item self-reported fatigue questionnaire
Mean Change from Baseline in Subject Global Assessment
A 5-point scale assessing overall perception of frequency and severity of sarcoid symptoms
Assessments of Population Pharmacokinetics (PPK)
Trough plasma concentration

Full Information

First Posted
April 4, 2022
Last Updated
March 29, 2023
Sponsor
Kinevant Sciences GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05351554
Brief Title
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
Acronym
RESOLVE-Heart
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Sponsor business decision not related to safety
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kinevant Sciences GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Cardiac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Experimental
Arm Description
Namilumab with prednisone, or equivalent
Arm Title
Treatment Arm 2
Arm Type
Placebo Comparator
Arm Description
Placebo with prednisone, or equivalent
Arm Title
Treatment Arm 3
Arm Type
Experimental
Arm Description
Namilumab with current dose of prednisone, or equivalent
Intervention Type
Drug
Intervention Name(s)
Namilumab
Intervention Description
Namilumab administered subcutaneously with prednisone or equivalent
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered subcutaneously to match namilumab dosing with prednisone or equivalent
Intervention Type
Drug
Intervention Name(s)
Open label Namilumab
Intervention Description
Namilumab administered subcutaneously, with current dose of prednisone or equivalent
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Incidence and Magnitude of Treatment-Emergent Laboratory Abnormalities
Time Frame
Baseline to Week 34
Title
Change from Baseline in Vital Signs
Description
Measure of the change in participants in blood pressure (mm Hg)
Time Frame
Baseline to Week 34
Title
Change from Baseline in Vital Signs
Description
Measure of the change in participants heart rate (beats per minute)
Time Frame
Baseline to Week 34
Title
Change from Baseline in Electrocardiogram (ECG) Parameters
Description
Measure of heart rate (beats per minute), PR Interval (mSec), and QT Interval (mSec)
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in Maximum Standardized Uptake Value (SUVmax)
Description
Measurement of activity in Positron Emission Tomography (PET)
Time Frame
Baseline to Week 34
Title
Cumulative Arrhythmia Burden
Description
Percentage of participants with clinically significant arrhythmia
Time Frame
Baseline to Week 34
Title
Hospitalization for Cardiac Events
Description
Percentage of participants hospitalized for cardiac events
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in Echocardiogram findings
Description
Percent Left Ventricular Ejection Fraction (LVEF)
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in Echocardiogram findings
Description
Percent Global Longitudinal Strain
Time Frame
Baseline to Week 34
Title
Cumulative Oral Steroid Use and Toxicity
Description
Measure of participants oral corticosteroid use and associated toxicities
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in Glycosylated Hemoglobin
Time Frame
Baseline to Week 34
Title
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
Title
Mean Change from Baseline in Multi-Organ Health Status Questionnaire
Description
Measure of Health-Related Quality of Life
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in The Fatigue Assessment Scale (FAS)
Description
10 item self-reported fatigue questionnaire
Time Frame
Baseline to Week 34
Title
Mean Change from Baseline in Subject Global Assessment
Description
A 5-point scale assessing overall perception of frequency and severity of sarcoid symptoms
Time Frame
Baseline to Week 34
Title
Assessments of Population Pharmacokinetics (PPK)
Description
Trough plasma concentration
Time Frame
Baseline to Week 34

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hayes Dansky, MD
Organizational Affiliation
Kinevant Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Kinevant Study Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kinevant Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Kinevant Study Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Kinevant Study Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Kinevant Study Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kinevant Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21234
Country
United States
Facility Name
Kinevant Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Kinevant Study Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Kinevant Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Kinevant Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Kinevant Study Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Kinevant Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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