Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis

Phase 1

• Conditions: Patients with active ulcerative colitis; MedDRA version: 18.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-005635-14-LV
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Signed informed consent,
2.Men or women aged 18 to 75 years,
3.Active ulcerative colitis, except proctitis limited to 15 cm ab ano, confirmed by endoscopy and histology,
4.Established disease (presence of blood and/or mucus in the stools) or new diagnosis (presence of blood in the stools for at least 14 days prior to baseline visit),
5. Clinical Activity Index (CAI) > 4 and = 12 and Endoscopic Index (EI) = 4,
6. Insufficient response or intolerance to a previous or current treatment with mesazaline -containing or -releasing drugs

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 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

1.Crohn's disease, indeterminate colitis, ischaemic colitis, radiation colitis, microscopic colitis (i.e., collagenous colitis and lymphocytic colitis, incomplete microscopic colitis), diverticular disease associated colitis,
2.Toxic megacolon or fulminant colitis,
3.Colon resection,
4.Evidence of infectious colitis (e.g., pathogenic bacteria or Clostridium difficile toxin in stool culture at screening),
5.Malabsorption syndromes,
6.Celiac disease,
7.Bleeding hemorrhoids,
8.Active peptic ulcer disease
9.Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
10.Hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, psychiatric disorders or infection if careful medical monitoring is not ensured,
11.Any severe infectious disease (e.g., tuberculosis, AIDS),
12.Severe co-morbidity substantially reducing life expectancy,
13.History of colorectal cancer,
14.History of cancer (other than colorectal) in the last 5 years, except for basal cell carcinoma,
15. Immunosuppressants, TNF-alpha-antagonists or anti-integrin therapy within 3 months and/or corticosteroids (oral, inhalative, intravenous [IV] or topical rectal) within 4 weeks prior to baseline,
16. Current relapse occurred under maintenance treatment with > 2.4 g mesalazine per day,
17. Abnormal renal function (Serum Cystatin C > upper limit of normal [ULN]) at screening visit,
18. Abnormal hepatic function (ALT, AST or AP > 2.5 x ULN) or liver cirrhosis at screening visit,
19. Known intolerance/hypersensitivity/resistance to the IMP or drugs of similar chemical structure or pharmacological profile, or to any of the other constituents of the IMP,
20. Doubt about the patient’s cooperation, e.g., because of addiction to alcohol, drugs or medicines,
21. Existing or intended pregnancy or breast-feeding,
22. Participation in another clinical trial within the last 30 days prior to screening visit, simultaneous participation in another clinical trial, or previous participation in this trial and having received IMP.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of a 8-week treatment with once-daily 9 mg budesonide in patients with active ulcerative colitis.<br>;Secondary Objective: Secondary objectives are to study safety and tolerability in the form of adverse events and laboratory parameters.<br>;Primary end point(s): Rate of clinical remission at final/withdrawal visit;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Rate of clinical improvement at final/withdrawal visit<br>•Number of stools per week<br>•Number of bloody stools per week<br>•Number of days with urgency per week<br>•Time to first resolution of clinical symptoms<br>•Rate of endoscopic remission/improvement at final/withdrawal visit<br>•Rate of histological remission/improvement at final/withdrawal visit<br>•Course of faecal calprotectin<br>;Timepoint(s) of evaluation of this end point: Each visit, if not otherwise defined.