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

NCT ID: NCT01018238

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2009-11-30

Brief Summary

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

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.

Conditions

Inflammation; Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo arm

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)

Cohort 1

Group Type: EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type: DRUG

Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

Cohort 2

Group Type: EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type: DRUG

Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

Cohort 3

Group Type: EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type: DRUG

Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

Cohort 4

Group Type: EXPERIMENTAL

NNC 0151-0000-0000

Intervention Type: DRUG

Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

Interventions

NNC 0151-0000-0000

Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)

Intervention Type: DRUG

placebo

Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Clinical Trial Call Center

Lake Success, New York, United States

Countries

United States

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1112-1881

Identifier Type: OTHER

Identifier Source: secondary_id

NN8209-3608

Identifier Type: -

Identifier Source: org_study_id