Trial Outcomes & Findings for A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis (NCT NCT05351554)
NCT ID: NCT05351554
Last Updated: 2025-04-17
Results Overview
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.
TERMINATED
PHASE2
1 participants
Baseline up to approximately 2 months
2025-04-17
Participant Flow
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.
Participant milestones
| Measure |
Namilumab
A single participant received two doses of 150 mg (milligrams) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Namilumab
A single participant received two doses of 150 mg (milligrams) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.
|
|---|---|
|
Overall Study
Study terminated by sponsor
|
1
|
Baseline Characteristics
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
Baseline characteristics by cohort
| Measure |
Namilumab
n=1 Participants
A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Age, Customized
50 - 70 years
|
1 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male or Female
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The Safety Population included all randomized participants who received at least one dose of study drug.
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.
Outcome measures
| Measure |
Namilumab
n=1 Participants
A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AEs
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
SAEs
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
AEs leading to discontinuation
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The Safety Population included all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Namilumab
n=1 Participants
A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Number of Participants With Treatment-emergent Laboratory Abnormalities
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The Safety Population included all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Namilumab
n=1 Participants
A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Number of Participants With Treatment-emergent Vital Sign Abnormalities
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The Safety Population included all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Namilumab
n=1 Participants
A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: 0 participants were enrolled in Cohort A.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to approximately 2 monthsPopulation: The study was terminated by the Sponsor due to a business decision (no safety concerns). The study participant did not consent to publishing his/her individual data. As there was only 1 participant in this study, no data are reported in order to protect and maintain participant privacy/confidentiality.
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.
Outcome measures
Outcome data not reported
Adverse Events
Namilumab
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Namilumab
n=1 participants at risk
Participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Baseline (Day 1) up to approximately 2 months
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Baseline (Day 1) up to approximately 2 months
|
|
General disorders
Injection site papule
|
100.0%
1/1 • Baseline (Day 1) up to approximately 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place