Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00267722
Protocol/serial number
291-412
Study information
Scientific title
Acronym
Study hypothesis
To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously to patients with moderate to severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease
Ethics approval
Approved by the Medical Ethics Committee on 03/02/2005, (ref: 04/325)
Study design
Treatment, non-randomized, open label, uncontrolled, single group assignment, efficacy study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Crohn's disease
Intervention
Two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously. Taking of blood samples, endoscopy and biopsies.
Intervention type
Drug
Phase
Phase II
Drug names
Visilizumab
Primary outcome measure
To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg of visilizumab administered intravenously to patients with moderate to severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease
Secondary outcome measures
1. To evaluate the pharmacokinetics of two consecutive daily doses of visilizumab administered intravenously in this patient population
2. To determine the risk-benefit relationship of visilizumab in this patient population
3. To assess immunogenicity of visilizumab in this patient population
4. To evaluate the safety, tolerability, clinical activity, pharmacokinetics and immunogenicity of retreatment (if warranted) of two consecutive daily doses of 10 mcg/kg visilizumab in patients with moderate-to-severe inflammatory, non-stricturing, non-penetrating forms of Crohn's disease
Overall trial start date
01/10/2004
Overall trial end date
31/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female, 18 to 70 years of age
2. A diagnosis of moderate-to-severe inflammatory, non-stricturing, non-penetrating Crohns disease, defined as Crohns Disease Activity Index (CDAI) >/= 250, C-Reactive Protein (CRP) >/= Upper Limit of Normal (ULN) and endoscopic evidence of moderate-to-severe active inflammatory disease
3. Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for three months after receiving the study drug
4. Women of childbearing potential who have negative serum pregnancy test
5. Patients who have been tested negative for Clostridium difficile within three weeks prior to treatment with the study drug
6. Patients who are capable of understanding the purpose and risks of the study and who provide signed and dated informed consent and an authorization to use protected health information (US sites only)
7. Patients who have Epstein-Barr virus (EBV) Deoxyribonucleic Acid (DNA) titers up to 30,000 copies/ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. History of lymphoproliferative disorder or a prior malignancy within five years or current malignancies (excluding non-melanoma skin cancers or in situ carcinoma of the cervix that has been adequately treated)
2. Pregnant women or nursing mothers
3. Any of the following hematologic abnormalities: White Blood Cell (WBC) <2500 /mm^3, platelets <150,000 /mm^3, hemoglobin <10 g/dl
4. Serologic evidence of infection with Human Immunodeficiency Virus (HIV) or Hepatitis B or C virus (HBV, HCV)
5. Presence of obstructive symptoms, confirmed by endoscopy showing an impassable stricture or Computed Tomography (CT) or barium studies showing stricture with prestenotic bowel dilation, within six months prior to receiving the study drug
6. Serious infections, particularly those of viral etiology e.g. known active cytomegalovirus (CMV) colitis, and patients who have had a history of opportunistic infections within the past year
7. Active infections that require antibiotic therapy (not to include use of antibiotics to control Crohns disease)
8. Started, or have a dose change of, sulfasalazine, 5-aminosalicylic acid (5-ASA), or antibiotics, probiotics, or topical therapies for Crohns disease within two weeks prior to receiving the study drug
9. Serious infections that required intravenous (IV) antibiotic therapy or hospitalization within eight weeks prior to receiving the study drug
10. Had an increased dose in corticosteroid medication two weeks prior to receiving the study drug, is receiving IV steroids, or, is receiving a daily dose of >40 mg prednisone, >9 mg budesonide, or equivalent
11. Received a live vaccine within six weeks prior to receiving the study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with the study drug)
12. Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within three months prior to receiving the study drug
13. Received cyclosporine or tacrolimus (FK506) within four weeks of receiving the study drug
14. Had a dose change of, or discontinued from, 6-mercaptopurine, azathioprine, or methotrexate within four weeks prior to receiving the study drug
15. Significant organ dysfunction, including cardiac, renal, liver, Central Nervous System (CNS), pulmonary, vascular, non-Crohn's disease-related gastrointestinal, endocrine, or metabolic (e.g. creatinine >1.6 mg/dl, alanineamino transferase [ALT] or aminotransferase [AST] > twice the Upper Limit of Normal [ULN], alkaline phosphatase >1.5 x ULN, history of myocardial infarction, congestive heart failure, or arrhythmias within six months prior to receiving the study drug)
16. Likely to require surgery in the next six months, such as those with clinically apparent abscesses or severely symptomatic stenoses
17. History of lymphoproliferative disorder
18. History of tuberculosis (TB) or other mycobacterial infection, or chest X-ray positive for previous TB infection
19. History of thrombophlebitis or pulmonary embolus
20. Histories of immune deficiency or autoimmune disorders other than Crohns disease (not including joint, skin, hepatic, and ocular inflammatory conditions that may be more typically associated with Crohns disease)
21. History of seizure with subtherapeutic blood levels of anticonvulsive medication (documented) within one week before study enrolment
Recruitment start date
01/10/2004
Recruitment end date
31/08/2007
Locations
Countries of recruitment
Germany, Netherlands, United States of America
Trial participating centre
Academic Medical Center
Amsterdam
1105AZ
Netherlands
Sponsor information
Organisation
PDL BioPharma Inc. (USA)
Sponsor details
34801 Campus Drive
Fremont
CA 94587
United States of America
mddyer@pdl.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Protein Design Labs Inc
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list