E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with Crohn's Disease |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
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 |
• To assess the efficacy of GSK1605786A compared with placebo in maintaining clinical remission in subjects with Crohn’s disease over 52 weeks. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the safety of GSK1605786A compared with placebo in subjects with Crohn’s disease. • To investigate the effect of GSK1605786A compared with placebo on health-related quality of life in subjects with Crohn’s disease. • To investigate the effect of GSK1605786A compared with placebo on healthcare related resource utilisation in subjects with Crohn’s disease. • To investigate the effect of GSK1605786A compared with placebo on work productivity in subjects with active Crohn’s disease. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects achieving clinical response (CDAI decrease ≥ 100points) and/or remission (CDAI <150) upon completion of treatment in Study CCX114151 or another GSK sponsored induction study 2. Written informed consent prior to any CCX114157 specific study procedures 3. Females of child-bearing potential must be sexually inactive or commit to use of consistent and correct use of contraceptive methods with a failure rate of < 1%, for the duration of this 52 week study as defined by the following: Abstinence Sexual inactivity by abstinence must be consistent with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Contraceptive Methods with a Failure Rate of < 1% • Oral contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label • Male partner sterilisation (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. • Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository) These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring subjects understand how to properly use these methods of contraception. Female subjects should not be enrolled if they are pregnant or lactating or if they plan to become pregnant during the time of study participation. For women of childbearing potential, a urine pregnancy test will be performed on the morning of the randomisation visit and at repeated intervals throughout the study. 4. Any medications being currently received for Crohn’s disease must remain stable throughout the study period with the exception of tapering of corticosteroids 5. Subjects on corticosteroids at entry must be willing to undergo corticosteroid dose tapering Note: Country-specific requirement for French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. |
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E.4 | Principal exclusion criteria |
1. If female, is pregnant, has a positive pregnancy test or is breast-feeding 2. Subjects with known or suspected coeliac disease or a positive screening test (antitissue transglutaminase antibodies) should have been excluded from enrolment into the induction studies. Subjects in whom a diagnosis of coeliac disease is subsequently suspected should have this excluded with testing for anti- tissue transglutaminase antibodies prior to enrolment into the maintenance study. 3. Known or suspected small bowel stricture 4. Enterocutaneous , abdominal or pelvic fistulae likely to require surgery during the study period 5. Current sepsis or infections requiring intravenous antibiotic therapy >2 weeks 6. Evidence of hepatic dysfunction, viral hepatitis, or liver function abnormalities: Exhibits serum ALT (SGPT) and/or AST (SGOT) values ≥2 times the upper limit of normal, or has a total bilirubin value ≥1.5 times the upper limit of normal: has alkaline phosphatase ≥ 1.5 times the upper limit of normal; has current or chronic history of liver disease including non-alcoholic steatohepatitis (NASH) or known hepatic or biliary abnormalities with the exception of Gilbert’s syndrome or asymptomatic gallstones. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Efficacy endpoints:
Proportion of subjects in clinical remission (CDAI score <150 points) at both Weeks 28 and 52 of the 52-week treatment period |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 54 |
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 | 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 | 4 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |