Crohn’s disease (CD) in patients with at least one perianal fistula. MedDRA version: 7.1 Level: LLT Classification code 10011401
Conditions
Sponsors
PDL BioPharma, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients will be considered for inclusion in this study if they meet all of the following criteria: 1) Male or female, 18 to 70 years of age 2) A diagnosis of CD and at least one documented external, draining, perianal fistula 3) Patients with reproductive potential who agree to use double-barrier methods of contraception during the study and for 3 months after receiving study drug 4) Women of childbearing potential who have a negative serum pregnancy test at baseline screening 5) Who have tested negative for Clostridium difficile within 3 weeks prior to treatment with study drug 6) 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) Who have EBV DNA titers up to 30, 000 copies/mL Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be ineligible for this study if they meet any one of the following criteria: 1) History of lymphoproliferative disorder or a prior malignancy within 5 years or current malignancies (excluding nonmelanoma skin cancers or carcinoma in situ of the cervix that has been adequately treated) 2) Pregnant women or nursing mothers 3) Any of the following hematologic abnormalities: WBC 40 mg prednisone, > 9 mg budesonide, or equivalent 12) Received a live vaccine within 6 weeks prior to receiving study drug (patients may not receive a live vaccine during treatment or for 12 weeks after treatment with study drug) 13) Received any monoclonal antibodies (including infliximab) or investigational agents or biologics within 3 months prior to receiving study drug 14) Received cyclosporine or tacrolimus (FK506) within 4 weeks of receiving study drug 15) Had a dose change of or discontinued from 6-mercaptopurine, azathioprine, or methotrexate within 4 weeks prior to receiving study drug 16) Significant organ dysfunction, including cardiac, renal, liver, CNS, pulmonary, vascular, non-CD-related gastrointestinal, endocrine, or metabolic (eg, creatinine >=1.6 mg/dL; ALT or AST >= twice the upper limit of normal (ULN); alkaline phosphatase >= 1.5 X ULN; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry). 17) History of lymphoproliferative disorder 18) History of tuberculosis (TB) or other mycobacteria 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 CD (not including joint, skin, hepatic, and ocular inflammatory conditions that may be components of CD) 21) History of seizure with subtherapeutic blood levels of anticonvulsive medications (documented) within one week before study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical activity of two consecutive daily doses of 10 mcg/kg visilizumab administered intravenously to patients with draining perianal fistulas associated with Crohn’s disease;Secondary Objective: 1) To evaluate the pharmacokinetics of two consecutive daily doses of 10 mcg/kg 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 15 mcg/kg visilizumab in patients with perianal fistulas associated with Crohn’s disease;Primary end point(s): The primary endpoint, which is determined by clinical examination, is clinical response, defined as external closure of at least 50% of perianal fistulas identified at baseline and observed at two consecutive study visits at least 4 weeks apart by Study Day 89, without an accompanying increase in dose(s) of concomitant medication(s) or the addition of new medication(s) as therapy for CD, or CD-related surgery. | — |
Countries
Germany
Outcome results
None listed