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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05351554

Acronym

RESOLVE-Heart

Enrollment

Registered

2022-04-28

Start date

2022-08-23

Completion date

2022-12-13

Last updated

2025-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis, Cardiac

Brief summary

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

Detailed description

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

Interventions

DRUGNamilumab

Specified dose on specified days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation	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.

Secondary

Measure	Time frame	Description
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	—
Number of Participants With Treatment-emergent Laboratory Abnormalities	Baseline up to approximately 2 months	—
Modified Glucocorticoid Toxicity Index (mGTI)	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).
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)	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.
Change From Baseline in Fatigue Assessment Scale (FAS)	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.
Change From Baseline in Subject Global Assessment (SGA)	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.
Cumulative Oral Steroid Use	Baseline up to approximately 2 months	—

Countries

United States

Participant flow

Pre-assignment details

The sponsor terminated the study for business reasons, not related to safety, after a single subject had received 2 doses. A separate cohort (Cohort A) was planned but did not enroll any participants.

Participants by arm

Arm	Count
Namilumab A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.	1
Total	1

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Study terminated by sponsor	1

Baseline characteristics

Characteristic	Namilumab
Age, Customized 50 - 70 years	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	0 Participants
Sex/Gender, Customized Male or Female	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 1
other Total, other adverse events	1 / 1
serious Total, serious adverse events	0 / 1

Outcome results

Primary

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.