An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)

Study Overview
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Brief Summary
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This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.

Official Title
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A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus

Conditions
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Inflammation, Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: NNC0114-0006
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (not pregnant and not nursing) Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA) If taken, background medication must be stable Exclusion Criteria: Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months Body mass index (BMI) below 18 kg/m^2 or above 38 kg/m^2

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0114-0006<br> | Drug: NNC0114-0006<br>* Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | From first administration of the trial product and up to week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½) |  | After the last dosing (Week 6) | 
| PK endpoint from serum NNC0114-0006: Accumulation based on the concentration |  | 2 weeks after the first (week 2) and the last dose (week 8) | 
| Change in serum levels of total IL-21 (Interleukin-21) |  | Week 0, week 26 | 
| Change in disease activity (SELENA-SLEDAI) |  | Week 0, week 12 | 
| Change in corticosteroid usage |  | Week 0, week 12 |