Inflammatory Bowel Disease (IBD) is the comprehensive term for disorders involving chronic inflammation in the gastrointestinal tract, often the small intestine and colon. It is believed to be a disorder mediated by T lymphocytes that arise in genetically susceptible persons as a result of a breakdown in the regulatory constraints on mucosal immune responses to enteric bacteria. Evidence suggests that Th1 T cells play an important pathogenetic role in Crohn´s disease. Level: PT Classification
Conditions
Interventions
Product Name: rCTB-401
Pharmaceutical Form: Oral solution
Other descriptive name: rCTB-401
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Sponsors
SBL Vaccin AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female aged 18 to 70 years. • A previously established diagnosis of Crohn´s disease verified with enteroclysis/small bowel follow-through, barium enema, endoscopy or histology. Should be performed within 24 months prior to study initiation. • Active disease of mild to moderate degree. CDAI (Crohn´s Disease Activity Index) score = 220 and = 400. • If ongoing treatment with sulphasalazine (SASP) or 5-ASA, corticostereoids or immunomodulators, the dose regimen must have been unchanged for at least 4 weeks and must have been initiated at least 12 weeks prior to inclusion. • CRP>5. • Give written informed consent to participate. • Willing and able to communicate with the Investigator and understand the requirements of the study. • Females should unless being menopausal agree to use reliable contraception (hormonal contraceptives or intra-uterine device), at least from 1 month prior to inclusion until three months after last intake of study drug. 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: • Treatment with metronidazole within the last four weeks. • Treatment with any biological drug, including infliximab, within 12 weeks. • Has received Dukoral in the last year. • Patient with a known intestinal stricture or symptoms or history indicating a stenotic condition. • Active fistulating disease. • Any condition which would limit the patient’s ability to complete the study in the opinion of the Investigator. • History of drug or chemical abuse in the year before the study. • Receipt of any other investigational product in the month before study entry. • Concomitant participation in any other clinical study. • Donation of blood 6 weeks before study entry or at any time during the study. • Females who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical response of rCTB given in a dose of 5 mg three times a week for two weeks to treat active Crohn`s disease (CD).;Secondary Objective: To evaluate safety and tolerability of rCTB given in a dose of 5 mg three times a week for two weeks. ;Primary end point(s): Frequency of patients with a reduction in CDAI score of 100 points or more between pre-dose and 2 weeks after last dose (at day 29). | — |
Countries
Sweden
Outcome results
None listed