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Namilumab for Cardiac Sarcoidosis (RESOLVE-Heart Trial)

Phase 2
Waitlist Available
Research Sponsored by Kinevant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 34
Awards & highlights

RESOLVE-Heart Trial Summary

This trial tests a new medication against a placebo (inactive) medication to see if it is effective. The trial is double-blind, meaning that neither the patients nor the trial staff know who is receiving the new medication or the placebo.

Eligible Conditions
  • Cardiac Sarcoidosis

RESOLVE-Heart Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 34
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 34 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Assessments of Population Pharmacokinetics (PPK)
Change from Baseline in Electrocardiogram (ECG) Parameters
Change from Baseline in Vital Signs
+11 more

Side effects data

From 2016 Phase 2 trial • 122 Patients • NCT02129777
4%
Nasopharyngitis
4%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Period: Namilumab 150 mg
Open-Label Period: Namilumab 150 mg
Follow-up Period: Placebo
Follow-up Period: Namilumab 20 mg
Follow-up: Namilumab 150 mg
Double-Blind Period: Placebo
Double-Blind Period: Namilumab 20 mg
Double-Blind Period: Namilumab 50 mg
Double-Blind Period: Namilumab 80 mg
Open-Label Period: Namilumab 80 mg
Follow-up Period: Namilumab 80 mg
Follow-up Period: Namilumab 50 mg

RESOLVE-Heart Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Arm 3Experimental Treatment2 Interventions
Namilumab with current dose of prednisone, or equivalent
Group II: Treatment Arm 1Experimental Treatment2 Interventions
Namilumab with prednisone, or equivalent
Group III: Treatment Arm 2Placebo Group2 Interventions
Placebo with prednisone, or equivalent
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Namilumab
2014
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

Kinevant Sciences GmbHLead Sponsor
3 Previous Clinical Trials
363 Total Patients Enrolled
Hayes Dansky, MDStudy DirectorKinevant Sciences
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being included in this experiment?

"Affirmative. According to the clinicaltrials.gov listing, this clinical trial is still seeking participants since it was initially posted on June 30th 2022 and recently updated on November 11th 2022. The study requires that 30 patients be recruited from 13 various locations across the nation."

Answered by AI

Is Namilumab a secure treatment option for individuals?

"Namilumab's safety was assigned a score of 2, as evidence exists to suggest that it is safe but there are still no indications regarding its efficacy."

Answered by AI

Are there still openings for participants in this experiment?

"Affirmative. The clinicaltrials.gov database demonstrates that this research study has been open since June 30th 2022 and is still searching for participants as of November 11th 2022. A total of 30 individuals will be accepted from 13 different sites across the US."

Answered by AI

How many medical facilities in this state are conducting the investigation?

"At the moment, 13 different medical sites are running this trial; these locations span from New Haven to Palo Alto and Denver. To reduce travel commitments for potential participants, it is best that they select a site close by."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Kinevant Study Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
2022. "A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05351554.
~0 spots leftby Apr 2025
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