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

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Inflammation; Systemic Lupus Erythematosus

Treatments: Drug: NNC0114-0006; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01689025

2011-005699-41 (EudraCT Number)

U1111-1125-9646 (Other Identifier)

NN8828-4002

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

NNC0114-0006

Experimental group

Treatment:

Drug: NNC0114-0006

Placebo

Placebo Comparator group

Treatment:

Drug: placebo