A Phase 2 interventional study of Namilumab in Sarcoidosis, Cardiac, sponsored by Kinevant Sciences GmbH. Terminated at 12 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Kinevant Sciences GmbH · Phase 2, Interventional, and Treatment
A Randomized, Double-blind, Placebo-controlled, Study with an Open-label Cohort.
Study was terminated after a single participant had received 2 doses.
278 studies on the registry are indexed under Sarcoidosis; 57 are open to participants now.
This study's enrollment of 1 is below the median of 54 across 154 interventional studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →Kinevant Sciences GmbH is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
A single participant received two doses of 150 milligrams (mg) of namilumab subcutaneously (SC) at baseline (Day 1) and on Day 15.
Drug: Namilumab
Specified dose on specified days
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation
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.
Time frame: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Laboratory Abnormalities
Time frame: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Vital Sign Abnormalities
Time frame: Baseline up to approximately 2 months
Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax)
Time frame: Baseline up to approximately 2 months
Change From Baseline in PET Mean Standardized Update Value (SUVmean)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Total Glycosylation
Time frame: Baseline up to approximately 2 months
Number of Participants Hospitalized for Cardiac Events
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE)
Time frame: Baseline up to approximately 2 months
Cumulative Oral Steroid Use
Time frame: Baseline up to approximately 2 months
Modified Glucocorticoid Toxicity Index (mGTI)
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).
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C)
Time frame: Baseline up to approximately 2 months
Number of Participants Requiring Rescue Therapy
Time frame: Baseline up to approximately 2 months
Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A)
Time frame: Baseline up to approximately 2 months
Mean Change From Baseline in King's Sarcoidosis Questionnaire (KSQ)
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.
Time frame: Baseline up to approximately 2 months
Change From Baseline in Fatigue Assessment Scale (FAS)
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.
Time frame: Baseline up to approximately 2 months
Change From Baseline in Subject Global Assessment (SGA)
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.
Time frame: Baseline up to approximately 2 months
| Milestone | Namilumab |
|---|---|
| Started | 1 |
| Received at least 1 dose of study drug | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Study terminated by sponsor | 1 |
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.
| Participants | Namilumab |
|---|---|
| AEs | 1 |
| SAEs | 0 |
| AEs leading to discontinuation | 0 |
| Participants | Namilumab |
|---|---|
| Number of Participants With Treatment-emergent Laboratory Abnormalities | 0 |
| Participants | Namilumab |
|---|---|
| Number of Participants With Treatment-emergent Vital Sign Abnormalities | 0 |
| Participants | Namilumab |
|---|---|
| Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities | 0 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over Baseline (Day 1) up to approximately 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Namilumab | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Namilumab |
|---|---|
| RashSkin and subcutaneous tissue disorders | 1/1 |
| HeadacheNervous system disorders | 1/1 |
| Injection site papuleGeneral disorders | 1/1 |
The safety population included all participants who received at least one dose of study drug.
| Age, Customized(Participants) | Namilumab |
|---|---|
| 50 - 70 years | 1 |
| Sex/Gender, Customized(Participants) | Namilumab |
|---|---|
| Male or Female | 1 |
| Ethnicity (NIH/OMB)(Participants) | Namilumab |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Namilumab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
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Kinevant Sciences GmbH