E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 of the trial is to compare disease activity following a single s.c. dose of NNC142-0002 to placebo in subjects with moderately to severely active CD, measured 4 weeks after administration. |
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E.2.2 | Secondary objectives of the trial |
• To compare safety and tolerability of NNC142-0002 and placebo
• To compare change in disease activity at other time-points than Week 4, clinical response and remission, between subjects treated with NNC142-0002 and subjects receiving placebo
• To compare the quality of life (QoL) between subjects treated with NNC142-0002 and subjects receiving placebo
• To compare use of concomitant medication for CD between subjects treated with NNC142-0002 and subjects receiving placebo
• To describe the pharmacokinetics (PK) of NNC142-0002 during treatment
• To compare the pharmacodynamics (PD) response, by assessment of various biomarkers, between subjects treated with NNC142-0002 and subjects receiving placebo
• To describe the immunogenicity of NNC142-0002 |
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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 |
Endoscopy Biopsy Sub-Study (no separate protocol title, date and version)
Optional Exploratory Objectives at Specific Sites:
To describe PK and explore PD in endoscopically obtained biopsy specimens taken from gut mucosa of the subset of subjects consenting for the sub-study |
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E.3 | Principal inclusion criteria |
• Men and women (not pregnant and not nursing) of ≥18 and ≤75 years of age
• Subjects with CD for at least 3 months having active disease with a CDAI score of
220−450 (both included) and evidence of inflammation confirmed by a C-reactive protein (CRP) level ≥10 mg/L or endoscopic verification
• Biologic-naïve subjects or subjects having failed only one biologic therapy for CD (primary or secondary failure) |
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E.4 | Principal exclusion criteria |
• Any of the following: symptomatic bowel obstruction, short bowel syndrome, ileostomy or colostomy, surgical bowel resection within 6 months prior to randomisation or clinically relevant un-drained abscess
• History of dysplasia or malignancy in the colon
• Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to randomisation
• Body mass index (BMI) ≥38.0 kg/m^2 |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is change in disease activity assessed by the Crohn’s disease activity index (CDAI) from baseline to Week 4. |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Endoscopy Biopsy Sub-Study |
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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.8.3 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 | Information not present in EudraCT |
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 |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |