E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058815 |
E.1.2 | Term | Crohn's disease acute episode |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011402 |
E.1.2 | Term | Crohn's disease (colon) |
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 purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn’s Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn’s Disease |
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E.2.2 | Secondary objectives of the trial |
1. Proportion of subjects in clinical remission
2. Proportion of subjects in clinical response
3. Mean change from baseline in IBDQ
4. Safety of BMS-936557 in the induction period.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PK substudy:
Approximately 60 subjects (20/arm) at selected sites will participate in the PK substudy. Subjects who consent to the PK substudy will be taken additional samples to provide optimal PK
samples to facilitate population PK (popPK) analysis.
For additional details, see section 5.5.1 of the protocol.
Biopsy substudy:
All subjects are invited to participate in the biopsy substudy. For subjects who consent to and who are enrolled in the biopsy substudy, biopsies will be performed during the
required ileocolonoscopies. All samples will be sent to the central laboratory for the study and processed by a designated central pathology site for histological scoring using the GHDAS. The pathologist reading the sections will be blinded to the treatment assignment and endoscopic status.
For additional details, see section 5.4.4.2 of the protocol. |
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E.3 | Principal inclusion criteria |
• Adults subjects with confirmed CD for at least 3 months.
• Moderate to severely active CD as defined by CDAI 220 to 450
• In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy).
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E.4 | Principal exclusion criteria |
• UC or indeterminate colitis
• Short bowel syndrome
• Known stricture or noninflammatory stenosis leading to symptoms of obstruction
• Current stoma or current need for colostomy or ileostomy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Clinical remission at Week 11 (CDAI score of <150) |
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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) |
1. Proportion of subjects in clinical remission
2. Proportion of subjects in clinical response
3. Mean change from baseline in IBDQ
4. Safety of BMS-936557 in the induction period |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 7 and Week 11
2. Week 7 and Week 11
3. Week 11
4. Week 11 |
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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 | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | 3 |
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 | 24 |
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 |
France |
Hungary |
Poland |
South Africa |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |