An Investigation of NNC 0151-0000-0000 in Subjects With Systemic Lupus Erythematosus (SLE)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)

Conditions
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Inflammation, Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: NNC 0151-0000-0000
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of systemic lupus erythematosus (SLE) Disease duration: 6 months or longer Stable, mild to moderately active systemic lupus erythematosus (SLE) Receiving stable maintenance therapy Exclusion Criteria: Significant Lupus Nephritis Active central nervous system (CNS) disease Significant arterial or venous thrombosis (blood clots) within 12 months prior to trial start Body weight of 260 lbs/120 kg or more History of alcohol or substance abuse History of cancer Infections Viral infections: HIV, Hepatitis B or C, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Varicella-Zoster Virus (VZV), or Herpes Simplex Virus (HSV-1 or HSV-2) Tuberculosis Severe systemic bacterial, viral or fungal infections within the past 12 months prior to trial start Immunosuppressive and immune modulating therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo arm<br> | Drug: placebo<br>* Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)<br>|
| Experimental: Cohort 1<br> | Drug: NNC 0151-0000-0000<br>* Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)<br>|
| Experimental: Cohort 2<br> | Drug: NNC 0151-0000-0000<br>* Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)<br>|
| Experimental: Cohort 3<br> | Drug: NNC 0151-0000-0000<br>* Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)<br>|
| Experimental: Cohort 4<br> | Drug: NNC 0151-0000-0000<br>* Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed adverse events |  | From day -28 to day 113 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |