Phase III study to assess efficacy and safety of D9421-C 9 mg with active Crohn’s Disease in Japa

Phase 1

• Conditions: Active Crohn’s Disease; MedDRA version: 19.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-004132-20-Outside-EU/EEA
• Lead Sponsor: AstraZeneca K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-28
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

1. Female or male =15 years of age
2. Diagnosis of Crohn’s Disease, verified by X-ray, endoscopy or histology
3. Main active disease of the ileal, ileocecal region, and/or ascending colon
4. Signed informed consent has to be obtained from the patient, and patient’s legal representative additively if necessary, prior to conducting any study-related procedures.
5. If patients treated with medication before entry, subjects should fulfil the following criteria:
If treated with partial nutrition treatment (=1200 kcal/day), the treatment has to be on constant calories from 14 days prior to randomisation until the study completion or discontinuation (including tapering period).
If treated with azathioprine (=2.0 mg/kg/day) or 6-mercaptopurine (=1.2 mg/kg/day), the treatment has to be on constant dose from 12 weeks prior to randomisation until the study completion or discontinuation (including tapering period).
6. Ability to read, write and to fill a diary card and HRQL questionnaire as instructed.

For randomisation in the study patients must fulfil all of the following criteria:
7.Having mild to moderate active Crohn’s disease, defined as CDAI score of 180-400 based on the patient’s condition for 7 consecutive days prior to the Visit 2

Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 109
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Having ileostomy or pouch and/or colostomy.
2. Having active Crohn’s disease in the rectum and/or anus
3. Having limited active Crohn’s disease in upper gastrointestinal only.
4. Having resection of ileum totalling more than 100 cm.
5. Having previous total gastrectomy.
6. Having a known or suspected systemic infection (eg, HBV, HCV, HIV infection).
7. Other complications such as abscess, obstruction, stricture with proximal dilatation, and/or active fistula.
8. Being candidates for immediate major surgery (including endoscopic treatment, but excluding tooth extraction and cataract surgery) or unlikely to complete the trial due to a poor general condition.
9. Having histological documented gastrointestinal malignancy or high-grade dysplasia within five years prior to randomisation.
10. Having a history of carcinoma (excluding basal and squamous skin cell carcinoma) within five years prior to randomisation.
11. Having uncontrolled diabetes. Patient needs to have his/her diabetes controlled by diet, exercise, and medical treatment and without complications such as neuropathy, nephropaty or retinopathy.
12. Having active peptic disease, such as a verified diagnose of esophagitis, gastric, duodenal ulcers and infectious diarrhea.
13. Having rheumatoid arthritis.
14. Having ankylosing spondylitis.
15. Having parathyroid disease.
16. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis at Visit 1, which, in the opinion of the investigator(s), may put the patient at risk because of his/her participation in the study.
17. Having a clinically relevant renal, hepatic, cardiovascular or psychiatric disease as judged by the investigator.
18. Have received or requiring glucocorticosteroids for any reason, or antibiotics for treatment of Crohn’s Disease (eg, sulfasalazine, metronidazol, and ciprofloxacin), within two weeks prior to randomisation and during study period. Use of topical steroids (eg, nasal steroids, eye drops and steroid ointments) is eligible.
19. Having been administered or requiring Mesalazine (=2251 mg/day) from 14 days before randomisation until the day before the randomisation.
20. Have received infliximab within 8 weeks or adalimumab within 2 weeks prior to randomisation
21. Have received methotrexate, cyclosporine or tacrolimus hydrate within 12 weeks prior to randomisation
22. Have received granulocytapheresis within 4 weeks prior to randomisation
23. Have received immunisation with live viruses (eg, polio) or live bacteria (eg, tubercle bacilli) within 12 weeks prior to randomisation.
24. Requiring concomitant medications listed in Section 5.6.3 during the study period.
25. Being pregnant or breast-feeding. Female patients have to be postmenopausal, surgically sterile or using medically accepted contraceptive measures.
26. Known hypersensitivity to budesonide, other glucocorticosteroids, any of the excipients of D9421-C capsule, salicylate esters such as Mesalazine, salicylates, or salazosulfapyridine.
27. Scheduled to undergo any types of invasive treatment during the course of the study.
28. Have participated in any clinical study involving an investigational product 4 weeks prior to randomisation.
29. Have received any kind of experimental treatment within 12 weeks prior to randomisation eg, studies with new biologicals, surgical procedures in a clinical setting, leukocytapheresis and other experimental procedure.
30. Having previously been randomised in this

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified