Mild to moderate ulcerative colitis
Conditions
Interventions
Product Name: BGP-014 Capsules
Product Code: BGP-014
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Lactobacillus reuteri
Current Sponsor code: BGP-014
Other descriptive name: LACTOBACILLUS R
Sponsors
BioGaia Pharma AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 The subject has given written consent to participate in the study. 2 >18 years of age 3 Diagnosed previously with UC (> 6 months earlier) determined by clinical and endoscopic histopathology (pathology showing chronic inflammatory changes). =1 documented previous flare-up and with last resolved flare >3 months away 4 Active UC determined by sigmoidoscopy before randomisation of study (baseline) and defined as a total Mayo index score of 4 to 10 points 5 Mayo endoscopic subscore =1 (Mayo subscore, Findings of flexible proctosigmoidoscopy, Appendix A) 6 Rectal bleeding =1 (Mayo subscore, Rectal bleedings, Appendix A) 7 Permitted concomitant SoC medications include: • Oral aminosalicylates (5-ASA), with a stable dose (1.6-4.8g/ day) for 14± 2 days prior to screening, Visit 1 • Steroids (dose =15mg at screening, Visit 1) with further tapering of dose in accordance with SoC until steroid tx termination • Immunomodulator, as: 6-Mercaptopurine, Azathioprine, Methotrexate (Stable dose for > 12 weeks prior to screening, Visit 1) 8 In females of childbearing potential should be practicing at least 1 effective contraceptive method; oral or parenteral hormonal contraceptives; a vasectomized partner; or abstinence from sexual intercourse. The investigator will discuss with the subject the option of practicing at least 1 of the above methods for the duration of the study. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1 Involvement in any investigational drug or device study within 30 days prior to this study 2 Known intolerance of 5-ASA or sulphasalazine medications 3 Biologics or FMT treatment less than 12 weeks before screening 4 No 5-ASA or steroid topical treatment is allowed 5 Antibiotic treatment 38.5 °C, at Visit 1 9 Anaemia, Hb value below 100 10 Evidence of on-going toxic megacolon 11 Presence of obstructive diseases of the gastrointestinal system 12 Any clinically significant concomitant disease that might interfere with patient safety 13 Unwilling to withdraw probiotic supplements. Yoghurts without supplemented bacteria are permitted 14 Pregnant 15 Planned abdominal surgery 16 Judged unable by the physician to comprehend information regarding the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and tolerability of BGP-014 compared to placebo in mild to moderate UC patients on SoC treatment.;Secondary Objective: The exploratory objective is to explore the efficacy of BGP-014 compared to placebo in mild to moderate UC patients on SoC treatment.;Primary end point(s): Frequency and severity of adverse events;Timepoint(s) of evaluation of this end point: At 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory efficacy Endpoints: • Proportion of patients with Clinical remission at week 6. Total Mayo score =2. (Defined further as Mayo endoscopic subscore of 0 or 1, rectal bleeding subscore 0 and stool frequency subscore of 0 or a decrease from baseline of at least one unit.) • Proportion of patients with Clinical response at week 6. Total Mayo score improvement =3 units. Reduction in rectal bleeding subscore at least 1 unit decrease from baseline. • Proportion of patients with Clinical response from baseline in modified Mayo score improvement =2 units or absolute resolution in modified Mayo subscores. Proportions of patients with reduction in rectal bleeding subscore at least 1 unit decrease from baseline. • Endoscopic improvement (Proportion of patients with decrease from baseline of at least 1 unit in Mayo endoscopic score) • To evaluate the change from baseline in faecal calprotectin level • Proportion of patients with change from a level >200mg/kg to =50 mg/kg • Proportion of patients with change from a level >200mg/kg to =200 mg/kg • Time to symptom relief and symptom resolution based on PROs (Symptom relief defined as reduction of one unit from baseline in rectal bleeding subscore and/or stool frequency subscore. Symptom resolution is rectal bleeding subscore and/or stool frequency subscore of 0.) • Change from baseline in abdominal pain. VAS scale from 10-0. • To evaluate the change from baseline in patient reported Short Health Scale ;Timepoint(s) of evaluation of this end point: At 6 weeks | — |
Countries
Sweden
Contacts
Public ContactPetra Jones Lierud
BioGaia Pharma AB
Outcome results
None listed