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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004576-57-DE

Enrollment

777

Registered

2019-01-08

Start date

2019-04-26

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 Concentra

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;Secondary Objective: •To study safety and tolerability by evaluation of adverse events (AEs) and laboratory parameters, •To assess patients’ quality of life;Primary end point(s): •Rate of patients with clinical and endoscopic remission at the EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment (EOT)/withdrawal visit	—

Measure

Time frame

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;Secondary Objective: •To study safety and tolerability by evaluation of adverse events (AEs) and laboratory parameters, •To assess patients’ quality of life;Primary end point(s): •Rate of patients with clinical and endoscopic remission at the EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment (EOT)/withdrawal visit

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Secondary

Measure	Time frame
Secondary end point(s): • Rate of patients with deep endoscopic remission • Rate of patients with complete clinical remission;Timepoint(s) of evaluation of this end point: After 8 weeks of treatment (EOT)/withdrawal visit.	—

Countries

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

Contacts

Public ContactClinical Research and Development

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de+4976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026