Investigation of the safety and effectiveness of Dietzia C79793-74 for moderate to severe Crohn's disease

Phase 1

Completed

• Conditions: Crohn's disease; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12614000465651
• Lead Sponsor: Centre for Digestive Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-02
• Study Completion: 2016-02-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Males and females of non-childbearing potential, aged 18-75
- Diagnosis of moderate to severe Crohn's disease

Exclusion Criteria

- Females of childbearing potential, pregnant or lactating females
- Unwilling to practice two effective methods of contraception
- A diagnosis of ulcerative colitis, pouchitis, indeterminate colitis
- Any other significant GI condition
- Evidence of cardiac impairment, insufficiency or disease, particularly cardiac valvular disease
- Severe hepatic or renal disease or impairment
- Known diagnosis with Type 2 diabetes mellitus
- History of or current infection with rheumatic fever
- Major immunodeficiency or immunosuppression
- Recently taken, actively taking or are expected to require prohibited medications

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical safety as determined by laboratory tests, vital signs, 12-lead electrocardiogram, physical examination, urinalysis, blood culture and adverse event reporting. <br>[Throughout study from Baseline (Day -28) to Day 140]

Secondary Outcome Measures

Name	Time	Method
Improvment in Crohn's disease activity index (CDAI)[At 8 weeks (conclusion of Dietzia C79793-74 dosing)];Improvement in health-related quality of life using the Inflammatory Bowel Disease Questionnaire (IBDQ)[At 8 weeks (conclusion of Dietzia C79793-73 dosing)]