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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01689025

Enrollment

Registered

2012-09-20

Start date

2012-09-30

Completion date

2014-02-28

Last updated

2014-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Systemic Lupus Erythematosus

Brief summary

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.

Interventions

DRUGNNC0114-0006

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

DRUGplacebo

Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of Adverse Events (AEs)	From first administration of the trial product and up to week 26

Secondary

Measure	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

Countries

Hungary, Poland, Serbia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026