NCT05351554: RESOLVE-Heart

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

Terminated Phase 2 Results posted Last updated 17 April 2025

What this trial tests

Phase 2 trial testing Namilumab in Sarcoidosis, Cardiac in 1 participant. Terminated before completion.

Timeline

23 August 2022

Primary endpoint
15 November 2022

13 December 2022

Quick facts

Lead sponsor	Kinevant Sciences GmbH
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	23 August 2022
Primary completion	15 November 2022
Estimated completion	13 December 2022
Sites	12 locations across United States

Drugs / interventions tested

• Namilumab — full drug profile →

Conditions studied

• Sarcoidosis, Cardiac — all drugs for Sarcoidosis, Cardiac →

Sponsor

Kinevant Sciences GmbH — full company profile →

Who can join

18 and older, any sex, with Sarcoidosis, Cardiac. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation Primary · 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

AEs

Group	Value	95% CI
Namilumab	1

SAEs

Group	Value	95% CI
Namilumab	0

AEs leading to discontinuation

Group	Value	95% CI
Namilumab	0

Number of Participants With Treatment-emergent Laboratory Abnormalities Secondary · Baseline up to approximately 2 months

Group	Value	95% CI
Namilumab	0

Number of Participants With Treatment-emergent Vital Sign Abnormalities Secondary · Baseline up to approximately 2 months

Group	Value	95% CI
Namilumab	0

Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities Secondary · Baseline up to approximately 2 months

Group	Value	95% CI
Namilumab	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline (Day 1) up to approximately 2 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Namilumab

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (3 terms — click to expand)

Reaction	System	Namilumab
Rash	Skin and subcutaneous tissue disorders	—
Headache	Nervous system disorders	—
Injection site papule	General disorders	—

Data from ClinicalTrials.gov NCT05351554 adverse events section.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cardiac sarcoidosis: phenotypes, diagnosis, treatment, and prognosis.
   Lehtonen J, Uusitalo V, Pöyhönen P, Mäyränpää MI, et al · · 2023 · cited 117× · PMID 36924191 · DOI 10.1093/eurheartj/ehad067
2. Sarcoidosis: Updates on therapeutic drug trials and novel treatment approaches.
   Obi ON, Saketkoo LA, Russell AM, Baughman RP. · · 2022 · cited 31× · PMID 36314034 · DOI 10.3389/fmed.2022.991783
3. Cardiac Sarcoidosis-Diagnostic and Therapeutic Challenges.
   Korthals D, Bietenbeck M, Könemann H, Doldi F, et al · · 2024 · cited 6× · PMID 38541919 · DOI 10.3390/jcm13061694
4. Novel Radiotracers for Molecular Imaging of Myocardial Inflammation: an Update Focused on Clinical Translation of Non-18F-FDG Radiotracers.
   Shi T, Miller EJ. · · 2023 · cited 6× · PMID 36926261 · DOI 10.1007/s12410-023-09574-4
5. Treating Myocardial Inflammation in Cardiac Sarcoidosis: Why, With What, and for How Long?
   Blankstein R, Divakaran S. · · 2022 · cited 2× · PMID 36357137 · DOI 10.1016/j.jcmg.2022.07.016