Study for the Treatment of Crohn's Disease With Adacolumn

A Randomized, Prospective, Double-Blinded, Placebo-Controlled (Sham-Controlled) Study to Evaluate the Safety and Effectiveness of the Adacolumn Apheresis System for the Treatment of Moderate to Severe Crohn's Disease

The purpose of this study is to evaluate the safety and effectiveness of the Adacolumn Apheresis System as a treatment for the signs and symptoms of Crohn's disease.

Trial Features:

• Medical device (Non-drug option)
• Most patients can remain on current treatment regimen throughout the study

Components of the Study:

• Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
• Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
• 2:1 Randomization (treatment:sham)
• Open-Label extension offered to eligible patients

Key Inclusion Criteria:

• Moderate to severe Crohn's disease
• Adequate peripheral venous access
• Agree to participate in the required follow-up visits
• Able to complete a diary
• Signed written informed consent document and authorization for use of protected health information

Key Exclusion Criteria:

• Extremely severe Crohn's disease
• Known obstructive symptoms within the past 3 months
• Presence of toxic megacolon
• Major surgery within the past 6 weeks or anticipated need for surgery within 12 weeks
• Total colectomy, ileostomy, stoma or 100 cm of resected small bowel
• Requiring in-patient hospitalization
• A history of allergic reaction to heparin or heparin-induced thrombocytopenia
• A history of hypersensitivity reaction associated with an apheresis procedure or intolerance of apheresis procedures
• A history of severe cardiovascular or peripheral arterial diseases
• A history of cerebral vascular diseases
• Liver diseases
• Renal insufficiency
• Known bleeding disorder or use of concomitant anticoagulant therapy for purposes other than apheresis treatment
• Any hypercoagulable disorder
• Known infection with Hepatitis B or C, or HIV
• Severe anemia
• Leukopenia or granulocytopenia
• Evidence of current systemic infection
• Malignancy
• Pregnant, lactating or planning to become pregnant during the course of the investigational study
• Used within the last 30 days, an investigational drug, biologic or device or 5 half-lives, if known, for any investigational drug or biologic