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

Inflammation Clinical Trial

Official title:

A Multiple Dose, Randomised, Double-blind, Placebo-controlled, Multiple Site Study of Anti-C5a Receptor Antibody (NNC 0151-0000-0000) in Subjects With Systemic Lupus Erythematosus (SLE)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01018238
• Other study ID #: NN8209-3608
• Secondary ID: U1111-1112-1881
• Status: Withdrawn
• Phase: Phase 1
• First received: November 16, 2009
• Last updated: August 14, 2014
• Start date: November 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• NNC 0151-0000-0000
Multiple doses in the range of 0.05mg/kg to 0.30mg/kg administered subcutaneously (under the skin)
• placebo
Multiple doses of placebo (no active ingredients) administered subcutaneously (under the skin)

Locations

Country	Name	City	State
United States	Novo Nordisk Clinical Trial Call Center	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observed adverse events		From day -28 to day 113	No
Secondary	Number of adverse Events (including injection site reactions)		Every visit through study completion (Day 113)	No
Secondary	Pharmacokinetics: terminal half-life, trough values, serum concentrations		Day 1 through Day 113	No
Secondary	Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies		Day 1 through Day 113	No
Secondary	Clinical disease endpoints: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), British Isles Lupus Assessment Group (BILAG), and Quality of Life by use of SF-36 (QOL)		Day 1 through Day 113	No

External Links

•   Clinical Trials at Novo Nordisk