An open-label study to evaluate the efficacy, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset of Crohn's disease versus subject with longer exisiting Crohn's disease

Phase 1

• Conditions: Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-005376-29-HU
• Lead Sponsor: Academic Medical Center, Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-30
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

1. In the opinion of the investigator, the subject is capable of understanding and complying with
protocol requirements.
2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
3. Age 18 to 80.
4. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
5. Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
6. Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
7. Anti-TNF discontinued for at least 4 weeks prior to baseline.

GROUP 1 (EARLY CD):
8. Diagnosis of CD < 24 months prior to enrollment.
9. Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
or: need for 1 course of steroids since diagnosis
or: steroid dependency at any dose since diagnosis,
and additionally, but not mandatory, lack of efficacy or intolerance to thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine)(any duration). Patients using thiopurines must have been using the agent for > 3 months (last 4 weeks at stable dose).

GROUP 2 (LATE CD):
10. Diagnosis of CD > 24 months prior to enrollment.
11. Subject has been treated with corticosteroids and demonstrated failure to respond to corticosteroids and at least 3 months of thiopurines or intolerance to thiopurines
and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Previous exposure to any anti-integrin antibodies including vedolizumab, a4ß7 antibodies, ß7 antibodies, anti-MADCAM-1.
2. Contraindication for endoscopy.
3. History of colonic dysplasia or colonic cancer.
4. Presence of stoma.
5. Subjects with a pouch.
6. Received other biologics within the last 4 weeks of baseline.
7. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment.
8. Chronic hepatitis B or C infection.
9. Subjects with ALT or AST 3x the upper limit of normal measured at screening.
10. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment.
11. Active or latent tuberculosis.
12. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
13. Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
14. Positive PML subjective symptom checklist before enrollment.
15. Subjects with known allergy or hyposensitivity to vedolizumab or its components.
16. Cancer (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence). Subjects with a history of cancer and a documented 2-year disease free period before screening, may enter the study.
17. Early CD group: previous exposure to any anti-TNF.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified