Trial Outcomes & Findings for Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis (NCT NCT04017936)

NCT ID: NCT04017936

Last Updated: 2025-08-07

Results Overview

Change in c-reactive protein in participant plasma samples

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline to 28 days
• Results posted on: 2025-08-07

Participant Flow

Participant milestones

Measure	Anakinra 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care Continue standard of care treatment
Overall Study STARTED	7	10
Overall Study COMPLETED	7	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis

Baseline characteristics by cohort

Measure	Anakinra n=7 Participants 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care n=10 Participants Continue standard of care treatment	Total n=17 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	61 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	10 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 28 days

Population: Patient 5 excluded from Anakinra group outcome analysis.

Change in c-reactive protein in participant plasma samples

Outcome measures

Measure	Anakinra n=6 Participants 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care n=10 Participants Continue standard of care treatment
Change in Inflammation Marker	-43 mg/L Standard Deviation 36	7 mg/L Standard Deviation 41.56

SECONDARY outcome

Timeframe: Baseline to 180 days

Population: Reported as percent change of relative enhanced late gadolinium enhancement volume (%)

Change in late gadolinium enhancement evident on magnetic resonance imaging (MRI) scan

Outcome measures

Measure	Anakinra n=2 Participants 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care n=3 Participants Continue standard of care treatment
Change in Cardiac Fibrosis	17.7 percentage change Standard Deviation 14.7	12.3 percentage change Standard Deviation 13.3

Adverse Events

Anakinra

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anakinra n=7 participants at risk 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care n=10 participants at risk Continue standard of care treatment
Infections and infestations hospitalized for a diabetic foot infection	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.

Other adverse events

Measure	Anakinra n=7 participants at risk 100 mg/0.67 mL daily subcutaneous injection for 4 weeks Anakinra: Active Treatment	Standard of Care n=10 participants at risk Continue standard of care treatment
Infections and infestations Serious Infection	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Skin and subcutaneous tissue disorders Injection site reaction	42.9% 3/7 • Number of events 3 • 180 days Regular investigator assessment, phone call follow-up.	30.0% 3/10 • Number of events 3 • 180 days Regular investigator assessment, phone call follow-up.
Infections and infestations Bronchitis	28.6% 2/7 • Number of events 2 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.
Cardiac disorders Atrial Fibrillation	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.
Cardiac disorders Recurrent atrial tachycardia	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.
Infections and infestations Rhinovirus	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.
Infections and infestations Abdominal fullness	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Infections and infestations Worsening kidney function	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Musculoskeletal and connective tissue disorders Chest pain	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Musculoskeletal and connective tissue disorders Headache	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Blood and lymphatic system disorders Hypertension	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.
Blood and lymphatic system disorders Hypermatabolic lymph nodes	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	10.0% 1/10 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.
Skin and subcutaneous tissue disorders Skin Reaction	14.3% 1/7 • Number of events 1 • 180 days Regular investigator assessment, phone call follow-up.	0.00% 0/10 • 180 days Regular investigator assessment, phone call follow-up.

Additional Information

Dr. Jordana Kron, MD

Virginia Commonwealth University

Phone: 804-828-7565

Email: jordana.kron@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place