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

NCT01018238 | Withdrawn Phase 1

• 2 other identifiers: NN8209-3608U1111-1112-1881
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Inflammation; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Observed adverse events

  From day -28 to day 113

Secondary Outcomes (4)

• Number of adverse Events (including injection site reactions)

  Every visit through study completion (Day 113)

• Pharmacokinetics: terminal half-life, trough values, serum concentrations

  Day 1 through Day 113

• Pharmacodynamics: levels of serum, plasma, and urine markers, auto-antibodies

  Day 1 through Day 113

• 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

Study Arms (5)

Placebo arm

PLACEBO COMPARATOR

Drug: placebo

Cohort 1

EXPERIMENTAL

Drug: NNC 0151-0000-0000

Cohort 2

EXPERIMENTAL

Drug: NNC 0151-0000-0000

Cohort 3

EXPERIMENTAL

Drug: NNC 0151-0000-0000

Cohort 4

EXPERIMENTAL

Drug: NNC 0151-0000-0000

Interventions

NNC 0151-0000-0000 DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4

placebo DRUG

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Lake Success, New York, 11042-1008, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Inflammation; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 23, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 15, 2014

Record last verified: 2014-07

Locations

US (1)