Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine

• Register: EUCTR
• Last refreshed on: 26 February 2024
• Main ID: EUCTR2017-004576-57-DE
• Date of registration: 08/01/2019
• Prospective Registration: Yes
• Primary sponsor: Dr. Falk Pharma GmbH
• Public title: Novel budesonide capsules vs. budesonide tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine
• Scientific title: Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2
• Date of first enrolment: 26/04/2019
• Target sample size: 777
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-004576-57
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: double-dummy If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Czechia, Germany, Hungary, Latvia, Lithuania, Poland, Russian Federation, Serbia, Slovakia, Ukraine

Contacts

• Name: Clinical Research and Development
• Affiliation: Dr. Falk Pharma GmbH

• Name: Clinical Research and Development
• Affiliation: Dr. Falk Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent,
2. Men or women aged 18 to 75 years,
3. Diagnosis of UC confirmed by endoscopy and histology = 6 months prior to baseline,
4. Mildly to moderately active UC with disease extent = 15 cm
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 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 137

Exclusion criteria:
1. Severe active ulcerative colitis at baseline
2. Suspicion or definite diagnosis of 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,
3. Toxic megacolon or fulminant colitis,
4. Colon resection (except for appendectomy and benign polyps),
5. Malabsorption syndromes


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Patients with active ulcerative colitis refractory to standard treatment with mesalazine
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Product Name: Budesonide 9 mg prolonged-release capsule, hard (BUX-PVII prototype)
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype)
Pharmaceutical Form: Prolonged-release capsule, hard
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: CortimentMMX 9 mg
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Prolonged-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): •Rate of patients with clinical and endoscopic remission at the EOT/withdrawal visit

Secondary Objective: •To study safety and tolerability by evaluation of adverse events (AEs) and laboratory parameters,
•To assess patients’ quality of life

Main Objective: The primary objective is to prove the non-inferiority of an 8-week add-on treatment with once-daily 9 mg budesonide capsules and 6 mg budesonide capsules, respectively, versus active comparator 9 mg budesonide-MMX® tablets, for the induction of remission in patients with ulcerative colitis (UC) refractory to standard treatment with mesalazine

Timepoint(s) of evaluation of this end point: After 8 weeks of treatment (EOT)/withdrawal visit

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After 8 weeks of treatment (EOT)/withdrawal visit.

Secondary end point(s): • Rate of patients with deep endoscopic remission
• Rate of patients with complete clinical remission

Secondary ID(s)

BUX-4/UCA

Source(s) of Monetary Support

Dr. Falk Pharma GmbH

Ethics review

Status: Approved
Approval date: 26/04/2019
Contact: