| Primary | 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. | The Safety Population included all randomized participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | | Title | Denominators | Categories |
|---|
| AEs | | | | SAEs | | | | AEs leading to discontinuation | | |
| |
| Secondary | Number of Participants With Treatment-emergent Laboratory Abnormalities | | The Safety Population included all randomized participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Number of Participants With Treatment-emergent Vital Sign Abnormalities | | The Safety Population included all randomized participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Number of Participants With Treatment-emergent Electrocardiogram (ECG) Abnormalities | | The Safety Population included all randomized participants who received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Mean Change From Baseline in Positron Emission Tomography (PET) Maximum Standardized Update Value (SUVmax) | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |
| Secondary | Change From Baseline in PET Mean Standardized Update Value (SUVmean) | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Mean Change From Baseline in Total Glycosylation | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Number of Participants Hospitalized for Cardiac Events | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Mean Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Mean Change From Baseline in Global Longitudinal Strain (GLS) on Transthoracic Echocardiogram (TTE) | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |
| Secondary | Cumulative Oral Steroid Use | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | 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). | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |
| Secondary | Mean Change From Baseline in Glycosylated Hemoglobin (HbA1C) | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Number of Participants Requiring Rescue Therapy | | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| | |
| Secondary | Number of Participants Successfully Achieving Steroid Taper Without Requiring Rescue Therapy (Cohort A) | | 0 participants were enrolled in Cohort A. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Cohort A | Participants in Cohort A were to be randomized to either Namilumab or Placebo |
| | | |
| Secondary | 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. | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |
| Secondary | 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. | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |
| Secondary | 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. | 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. | Posted | | | | | | Baseline up to approximately 2 months | | | | ID | Title | Description |
|---|
| OG000 | Namilumab | A single participant received two doses of 150 mg of namilumab SC at baseline (Day 1) and on Day 15. |
| |