Synergistic Effect of Vedolizumab and Pentoxifylline

University of Miami

Status and phase: Completed; Early Phase 1

Conditions: Crohn Disease

Treatments: Drug: placebo; Drug: vedolizumab; Drug: Pentoxifylline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02953275

20160543

Details and patient eligibility

About

The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.

Enrollment: 37 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
• Patients who are good candidates to start standard dosing of vedolizumab
• Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
• Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
• Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
• Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening
• Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab
• Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion

Exclusion criteria

• Contraindications or history of allergy to PTX
• Known interaction of PTX with patient's current medications
• Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
• Pregnancy
• GFR <30 at any time in the 6 months prior to first infusion of VDZ
• Documented cirrhosis
• Age <18 or >80 years old
• Contraindication to colonoscopy at 24 week study time-point

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

vedolizumab plus pentoxifylline

Experimental group

Description:

Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as pentoxifylline 400 mg orally thrice daily.

Treatment:

Drug: Pentoxifylline

Drug: vedolizumab

vedolizumab plus placebo

Placebo Comparator group

Description:

Patients will receive standard induction and maintenance dosing of vedolizumab 300 mg intravenously as well as placebo orally thrice daily.

Treatment:

Drug: placebo

Drug: vedolizumab