NI-0401 in Active Crohn's Disease

NCT00630643 | Completed Phase 1 DMC

• 1 other identifier: NI-0401-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to assess the safety and tolerability of daily intravenous NI-0401 treatment, compared to matching placebo. And to assess the ability of NI-0401 to modulate the CD3 complex on T-cells.

Conditions

Moderate to Severe Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of intravenous NI-0401 .

  24 weeks

Secondary Outcomes (1)

• Immunological response defined as the percent change in the modulation of the CD3 complex on T-cells

Study Arms (2)

1

PLACEBO COMPARATOR

Drug: Placebo

2

EXPERIMENTAL

Biological: NI-0401 (anti-CD3 mAB)

Interventions

NI-0401 (anti-CD3 mAB) BIOLOGICAL

0.05 mg up to 10 mg

2

Placebo DRUG

Placebo

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 70 years of age.
• Crohn's Disease Activity Index (CDAI) between 220 and 450.
• Raised plasma CRP level.
• Endoscopic inflammation.
• Crohn's disease of at least 6 months duration, with colitis, ileitis, or ileocolitis, confirmed by endoscopy and histology within 28 days of study day 1.

You may not qualify if:

• Have received or are planned to receive immunization with a live vaccine within 6 weeks prior to receiving study drug and 12 weeks after treatment cessation.
• Concomitant disease:
• Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease (including a history of seizure disorders or ongoing chronic active conditions such as chronic active hepatitis)
• Previous diagnosis of, or known, malignancies
• Severe infections, such as hepatitis, pneumonia or pyelonephritis, in the past three months. Less serious infections in the past 3 months, such as acute upper respiratory tract infection (colds) or uncompliant urinary tract infection are permitted at the discretion of the investigator
• Active infection requiring antibiotic therapy
• Serum anti HCV positive, serum HBsAg positive, serum anti-HIV positive
• History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of acute CMV or EBV, active Pneumocystic Carinii
• History of active tuberculosis (TB) or currently undergoing treatment for TB. Patients with a positive TB skin test or chest x-ray are ineligible. Patients with a history of bacille Calmette Guerin (BCG) vaccination and a newly positive TB skin test or a chest X-ray showing fibrotic lesions consistent with previous TB are ineligible. The PPD skin test must be read between 48 and 72 hours
• Stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium Difficile toxin within 4 weeks prior to Study Day 1

Sponsors & Collaborators

• Light Chain Bioscience - Novimmune SA: lead

Study Officials

• Janeeke Van der Woude, MD

  Erasmus Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 7, 2008

Record last verified: 2008-02