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

Novo Nordisk

Status and phase: Withdrawn; Phase 1

Conditions: Inflammation; Systemic Lupus Erythematosus

Treatments: Drug: NNC 0151-0000-0000; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018238

U1111-1112-1881 (Other Identifier)

NN8209-3608

Details and patient eligibility

About

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).

Full description

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 5 patient groups, including a placebo group

Placebo arm

Placebo Comparator group

Treatment:

Drug: placebo

Cohort 1

Experimental group

Treatment:

Drug: NNC 0151-0000-0000

Cohort 2

Experimental group

Treatment:

Drug: NNC 0151-0000-0000

Cohort 3

Experimental group

Treatment:

Drug: NNC 0151-0000-0000

Cohort 4

Experimental group

Treatment:

Drug: NNC 0151-0000-0000