E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fistulizing Crohn’s Disease (CD) |
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E.1.1.1 | Medical condition in easily understood language |
Crohn’s disease is an inflammatory disease of the gastrointestinal tract. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10075465 |
E.1.2 | Term | Fistulizing Crohn's disease |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to evaluate the proportion of subjects with fistula healing at Week 30 in 2 different dose regimens of vedolizumab IV 300mg in subjects with fistulizing CD. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate fistula healing over a 30-week evaluation period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration. -Subjects who have historically had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFalpha antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD. |
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E.4 | Principal exclusion criteria |
-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI. -Subjects who have a CDAI score greater than 400. -Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine. -Subjects who have significant anal or rectal stenosis. -Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during Screening, other than related to the fistula(e). -Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist. -Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days of randomization. -Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab, etrolizumab, or anti- mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy. -Subjects who have active or latent tuberculosis. -Subjects who have a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), acquired human immunodeficiency virus (HIV), or are found to be seropositive at Screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint for this study is the proportion of subjects with a reduction of at least 50% from Day 1 in the number of draining fistulae at Week 30 (where closed fistulae are no longer draining despite gentle finger compression). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
-The proportion of subjects with a reduction of at least 50% from Day 1 in the number of draining perianal fistulae at both Week 22 and Week 30 (where closed fistulae are no longer draining despite gentle finger compression). -The proportion of subjects with 100% fistulae closure at Week 30 (where all fistulae are no longer draining despite gentle finger compression). -Time to first fistula closure. -Time to last (100%) fistulae closure. -Duration of fistula response (number of days with drainage) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
France |
Italy |
Netherlands |
Spain |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of trial will be the date of the last visit of the last subject at the Week 40 Follow-up Visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |