Patients with Moderately Active Crohn’s Disease Who Are Refractory or Intolerant to Immunosuppressants and/or Anti-TNF Agents MedDRA version: 7.1 Level: LLT Classification code 10011401
Conditions
Sponsors
Therakos
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Signed and dated informed consent must be obtained prior to conducting any study procedure. • Patients must be = 18 years of age. • Patients must have a body weight = 40 kg (88 lb). • Patients must have had Crohn’s disease for at least 6 months duration (with colitis, ileitis, or ileocolitis) confirmed by radiography or endoscopy. • Patients must have a CDAI = 220 to 10.0 mg/L (1.0 mg/dL) or evidence of active inflammatory luminal Crohn’s disease as demonstrated by superficial and/or deep ulcerations, pseudopolyps, and/or ulcerated stenosis on colonoscopy within 8 weeks of screening. • Patients who are receiving corticosteroids must be on a prednisone equivalent dose = 25 mg/day or an oral (PO) budesonide dose = 9 mg/day. • Patients who are receiving any of the following concomitant Crohn’s disease medications must have been on a stable dose of these medications for the specified period of time prior to confirmation of eligibility (this time period may include screening): - aminosalicylates, antibiotics, and immunosuppressants (i.e., 6-mercaptopurine, 6- MP; methotrexate, MTX; or azathioprine, AZA) for at least 4 weeks, - corticosteroids or PO budesonide for at least 2 weeks, - anti-TNF agents (i.e., infliximab or adalimumab) for at least 8 weeks. • Patients who have failed treatment with immunosuppressants and/or anti-TNF agents. • Patients who have discontinued treatment with any of the following Crohn’s disease medications must have done so for the specified period of time prior to confirmation of eligibility (this time period may include screening): - antibiotics, aminosalicylates, corticosteroids, or PO budesonide for at least 2weeks, - immunosuppressants (i.e., 6-MP, MTX, or AZA), or anti TNF agents (i.e., infliximab or adalimumab) for at least 8 weeks, - other investigative therapies - non biologics for at least 4 weeks and biologics for at least 8 weeks. • Patients who have fistulae are permitted, provided: - patients have predominantly luminal Crohn’s disease, and - fistulae are not associated with abscess formation. • Patients must have a platelet count = 50,000/µL (50.0 x 109/L). 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 who are concomitantly using biologic agents other than anti-TNF agents, cyclosporine (CSA), tacrolimus (FK506), mycophenolate mofetil (MMF), or investigational Crohn’s disease therapies. • Patients who, in the opinion of the Investigator, may not be able to remain on a stable dose of a concomitant Crohn’s disease medication for at least 12 weeks. • Patients with currently symptomatic untreated diarrhea, due to conditions other than inflammatory Crohn’s disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, or bacterial overgrowth). • Patients with symptomatic intestinal strictures. • Patients with stomas. • Patients with other local manifestations of Crohn’s disease such as abscesses, or other disease manifestations for which surgery might be indicated, or which might preclude utilization of a CDAI to assess response to therapy (such as “short gut” syndrome). • Patients who are unable to tolerate the extracorporeal volume shifts associated with ECP treatment due to the presence of any of the following conditions: uncompensated congestive heart failure, pulmonary edema, severe chronic obstructive pulmonary disease, severe asthma, renal failure, or hepatic failure. • Patients receiving total parenteral nutrition, as the sole source of nutrition, within 3 weeks of screening. • Female patients whose hemoglobin (Hgb) is 25,000 mm³, previous splenectomy or coagulation disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to explore the safety and activity of ECP treatment with UVADEX in inducing a clinical response (i.e., a CDAI decrease = 100 from baseline and/or a CDAI < 150) over a 12-week period in moderately active Crohn’s disease (CDAI = 220 to < 450) patients who are refractory or intolerant to immunosuppressants and/or anti-TNF agents. This study will also assess response to continued treatment during a 12-week extension period in patients who have a clinical response at week 12 of the treatment period and elect to participate in the extension period. Objective of the Substudy: The substudy will examine the immunomodulatory effects of ECP treatment of peripheral blood with UVADEX on prognostic indicators and markers of disease predisposition, biomarkers of ECP efficacy or action, and indicators of disease status. ;Secondary Objective: N/A;Primary end point(s): clinical response (i.e., a CDAI decrease = 100 from baseline and/or a CDAI < 150) over a 12-week period | — |
Countries
Germany
Outcome results
None listed