Trial · NCT05351554
A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
NCT05351554, Phase 2, Terminated, Kinevant Sciences GmbH; results first posted 2025-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis. Trials, record NCT05351554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05351554
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Safety, Tolerability, and Efficacy of Namilumab in Participants With Active Cardiac Sarcoidosis
- NCT number
- NCT05351554
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Kinevant Sciences GmbH
- Conditions
- Sarcoidosis, Cardiac
- Interventions
- Namilumab
- First posted
- 2022-04-28
- Last updated
- 2025-04-17
- Results first posted
- 2025-04-17
- Limitations and caveats
The sponsor terminated the study for business reasons, not related to safety, after a single participant had received 2 doses. No efficacy analyses were performed and no conclusions can be drawn due to the limited data available.
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Number of Participants With Treatment-emergent Laboratory Abnormalities | Baseline up to approximately 2 months | |
| Secondary | Number of Participants With Treatment-emergent Vital Sign Abnormalities | Baseline up to approximately 2 months | |
| Secondary | Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities | Baseline up to approximately 2 months | |
| Secondary | Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax) | Baseline up to approximately 2 months | |
| Secondary | Change From Baseline in PET Mean Standardized Update Value (SUVmean) | Baseline up to approximately 2 months | |
| Secondary | Mean Change From Baseline in Total Glycosylation | Baseline up to approximately 2 months | |
| Secondary | Number of Participants Hospitalized for Cardiac Events | Baseline up to approximately 2 months | |
| Secondary | Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Baseline up to approximately 2 months | |
| Secondary | Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE) | Baseline up to approximately 2 months |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Baseline up to approximately 2 months | The Safety Population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Laboratory Abnormalities | Baseline up to approximately 2 months | The Safety Population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Vital Sign Abnormalities | Baseline up to approximately 2 months | The Safety Population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities | Baseline up to approximately 2 months | The Safety Population included all randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax) | Baseline up to approximately 2 months | 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. | ||
| SECONDARY | Change From Baseline in PET Mean Standardized Update Value (SUVmean) | Baseline up to approximately 2 months | 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. | ||
| SECONDARY | Mean Change From Baseline in Total Glycosylation | Baseline up to approximately 2 months | 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. | ||
| SECONDARY | Number of Participants Hospitalized for Cardiac Events | Baseline up to approximately 2 months | 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. | ||
| SECONDARY | Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Baseline up to approximately 2 months | 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. | ||
| SECONDARY | Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE) | Baseline up to approximately 2 months | 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Namilumab | AEs | 1 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Namilumab | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation | Namilumab | AEs leading to discontinuation | 0 | Participants | |
| Number of Participants With Treatment-emergent Laboratory Abnormalities | Namilumab | 0 | Participants | ||
| Number of Participants With Treatment-emergent Vital Sign Abnormalities | Namilumab | 0 | Participants | ||
| Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities | Namilumab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Namilumab | 1 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Namilumab | 1 | |
| Overall Study | COMPLETED | Namilumab | 0 | |
| Overall Study | NOT COMPLETED | Namilumab | 1 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | Namilumab | 1 | 1 | |
| other | Headache | Nervous system disorders | Namilumab | 1 | 1 | |
| other | Injection site papule | General disorders | Namilumab | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Namilumab | 0 | 1 |
| Total, other adverse events | Namilumab | 1 | 1 |
| Total, serious adverse events | Namilumab | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05351554
GET https://conductscience.org/api/trials/v1/NCT05351554/registered