Crohn's disease
Conditions
Interventions
Product Code: AZD9056
Pharmaceutical Form: Tablet
Current Sponsor code: AZD9056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the plac
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study s must fulfil all of the following criteria: 1. Provision of written informed consent 2. Female or male =18 years of age. Female patients should have cessation of regular menses for more than 12 months, be surgically sterile, or using two forms of contraceptives throughout the study period. 3. Diagnosis of Crohn’s disease affecting ileum and/or colon verified by X-ray (small bowel follow-through), MRI and/or endoscopy 4. Disease activity defined as CDAI = 220 at Visit 2 5. Normal stool culture 6. Normal values of aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (ALP), and bilirubin 7. If treated with oral sulphasalazine, olsalazine or 5-ASA at entry, the dose should have been kept constant during two weeks prior to visit 2 8. If treated with azathioprine, methotrexate or 6-mercaptopurine at entry, the dose should have been kept constant for 3 months prior to Visit 2 9. For inclusion in the genetic component of the study, see Appendix C. If a patient declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient.. The patient will not be excluded from other aspects of the study described in this Clinical Protocol, should they not consent to genetic sampling. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Any significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal (other than Crohn’s disease), liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or patient´s ability to participate in the study 2. Ileostomy, ileo-pouch-anal anastomosis, ileorectal anastomosis or proctocolectomy 3. Active listeriosis or tuberculosis or positive screening for tuberculosis or a major episode of infection (e.g. pneumonia, pyelonephritis) requiring hospitalisation within 3 months prior to visit 2. 4. Septic complication, abscess, perforation, obstruction and/or fistulae, except for inactive perianal fistulae 5. Need for immediate surgery or unlikely to complete the trial due to poor general condition 6. Histologically documented gastrointestinal malignancy or high-grade dysplasia within the last five years prior to visit 1 7. History of carcinoma (excluding basal and squamous skin cell carcinoma) within the last five years prior to visit 1 8. Uncontrolled diabetes 9. Verified active gastric or duodenal ulcer 10. Rheumatoid arthritis 11. Sclerosing cholangitis 12. Clinically significant abnormal values for White blood cells (WBC), neutrophils or platelet in the opinion of the investigator. The limits are given in Section 3.3.5.1 13. Requirement for non-steroid anti-inflammatory drugs (NSAIDs) for chronic use except low dose aminosalicylic acid, ASA (<350 mg daily) for prophylaxis 14. Currently treated with glucocorticosteroids or stopped treatment with glucocorticosteroids less than two weeks prior to Visit 2. However, nasal glucocorticosteroid sprays and/or low potent steroid ointment are allowed 15. Received of infliximab or other biological treatments or cyclosporine within 12 weeks prior to Visit 2 16. Reception of any kind of experimental treatment (e.g. cytokines, probiotics, or helminthics) within 12 weeks prior to visit 2 17. Reception of immunization with live viruses (e.g. polio) or live bacteria (e.g. tubercle bacilli) within 12 weeks prior to visit 2 18. Known HIV or high risk for HIV infection 19. Clinically abnormal ECG, current treatment with antiarrhythmic drugs, history of clinically significant cardiac arrythmias, or resting QTc (according to Bazett’s correction method) greater than 460 ms on more than two baseline ECGs 20. Evidence of retinopathy on fundoscopic examination 21. Participation in any clinical study involving an investigational product within 90 days prior to randomization 22. Previous randomization in the present study 23. Alcohol or drug abuse or any other conditions associated with poor compliance or other reason for not being appropriate for the study, in the opinion of the investigator 24. History of known hypersensitivity to the excepients unse in the study investigational product. 25. Involvement the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to study the efficacy of a daily dose of 200 mg AZD9056 in patients with active CD affecting ileum and/or colon by assessment of the change in CDAI from baseline after 28 days treatment.;Primary end point(s): Change of CDAI from baseline after 28 days treatment. ;Secondary Objective: The secondary objectives of the study are: 1. To study efficacy by assessment of a) proportion of patients in clinical remission after 28 days, where clinical remission is defined as CDAI = 150 b) proportion of patients with clinical response after 28 days, where clinical response is defined as reduction in CDAI of at least 70 points from baseline c) time to remission d) time in study e) patient reported outcomes 2. To study safety by assessment of AEs, safety laboratory analyses, ECG, vital signs, fundoscopy and physical examination 3. To study pharmacodynamics of AZD9056 in plasma For explorative purposes the following will be analyzed but the results will not be presented in the study report: - Cytokines with focus on IL1-related cytokines - Matrix metalloproteinase (MMP1, MMP3) - Proteomics - Calprotectin in faeces | — |
Countries
Austria, Belgium, Germany, Hungary
Outcome results
None listed