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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1112-1881 | Other Identifier | WHO |
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See detailed description
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This trial is conducted in the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and signs of bioactivity of increasing repeated doses of NNC 151-0000-0000 in subjects with Systemic Lupus Erythematosus (SLE).
The trial was terminated before any patients were exposed to the trial drug based on new findings indicating that dose escalation with multiple doses should be performed in a different trial population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo arm | Placebo Comparator |
| |
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC 0151-0000-0000 | Drug | Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin) |
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| Measure | Description | Time Frame |
|---|---|---|
| Observed adverse events | From day -28 to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse Events (including injection site reactions) | Every visit through study completion (Day 113) | |
| Pharmacokinetics: terminal half-life, trough values, serum concentrations | Day 1 through Day 113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Clinical Trial Call Center | Lake Success | New York | 11042-1008 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| placebo | Drug | Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin) |
|
| Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies | Day 1 through Day 113 |
| Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL) | Day 1 through Day 113 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |