Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Budesonide-MMX®
Pharmaceutical Form: Film coated gastro-resistant tablet
INN or Proposed INN: BUDESONIDE
CAS Number: 51333-22-3
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Santarus, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with diagnosed UC fulfilling the following criteria at Screening are eligible for participation in the study: 1. Age 18 to 75 years, inclusive 2. Established diagnosis of UC, based on clinical history, exclusion of infectious causes (e.g., enteric bacterial infection, Clostridium difficile, parasites, ova, etc.), characteristic endoscopic findings, and histopathology results from biopsies. 3. UC of mild or moderate severity with an Ulcerative Colitis Disease Activity Index (UCDAI) score = 4 and = 10 according to Sutherland, with a mucosal appearance subscore of = 1 and a physician’s rating of disease activity of 1 or 2. 4. Currently experiencing active UC (flare) despite taking a therapeutic dose of an oral 5-ASA (e.g., mesalamine = 2.4 g/day, or equivalent dose of another 5-ASA for a minimum of 6 weeks prior to randomization. At screening, photographic evidence of active UC based on mucosal appearance must be obtained from the flexible sigmoidoscopy procedure. 5. Women of childbearing potential, or men of reproductive potential, must be willing to use an acceptable form of contraception. Acceptable forms of contraception are defined as those with a failure rate =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria at Screening are to be excluded from study participation: 1. Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line). 2. Patients with severe UC (UCDAI > 10 or PGA > 2), or patients not currently in an active phase or flare (defined in this study as a UCDAI score < 4). 3. Patients with infectious colitis (based on positive microbiologic tests, Clostridium difficile toxin, or ova and parasites per the central laboratory) or any recent history of infectious colitis (within 30 days of Screening). 4. Patients with a history of active malignancy or carcinoma in situ within the last 5 years (excised or treated non-melanoma skin cancers are not exclusionary). 5. Patients with an active ulcer or bleeding disorder that may affect evaluation of blood in the stool. 6. Evidence or history of toxic megacolon or bowel resection. 7. Patients with Crohn’s disease or indeterminate colitis. 8. Patients with a known hypersensitivity to budesonide or any of the ingredients of the budesonide MMX tablets 9. Patients with active tuberculosis or any other active systemic or local bacterial, fungal, or viral infection. 10. Patients with liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant impairment of the biohumoral parameters (= 2.5 x upper limit of normal [ULN] for ALT, AST, GGT, or = 2 x ULN for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert’s syndrome are not exclusionary. 11. Patients with severe diseases in other organs or systems. 12. Patients with local or systemic complications or other pathological states requiring therapy with corticosteroids and/or immunosuppressive agents. 13. Patients diagnosed with type 1 diabetes. 14.Patients diagnosed as having glaucoma, or with a family history of glaucoma in first degree relatives. 15. Patients with known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to the local privacy policy. 16. Patients with severe anemia (< 9 g/dL hemoglobin), leukopenia (< 2.5 x 109 white blood cells [WBC]/L), or granulocytopenia (< 1.2 x 109 cells/L). 17. Patients with a history of pancolitis (disease that extends to the hepatic flexure or beyond) for = 8 years or left-sided colitis (disease confined to the left colon [i.e., distal to the splenic flexure]) = 15 years who have not yet completed a surveillance colonoscopy for dysplasia/colorectal cancer screening within the past year. 18. Prior treatment with budesonide MMX. 19. Use of oral corticosteroids including other budesonide formulations within the last 4 weeks prior to randomization. 20. Use of any rectal 5-ASA or corticosteroid formulations within the last 2 weeks prior to randomization. 21. Use of immunosuppressive agents within the last 8 weeks prior to randomization. 22. Use of anti-tumor necrosis factor-alpha (anti-TNFa) agents or other biologic therapies within the last 3 months prior to randomization. 23. Participation in experimental therapeutic studies within the last 30 days prior to randomization (or within the last 3 months if in an anti-TNFa or biologic agent study). Note: patients who participated in observational-only studies (and who did not receive study therapy) are not excluded. 24. Any other medical condition that in the Principal Investigator’s opinion would make the administration of the study drug or study procedures hazardous to the patient, or obscure the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of UCDAI remission in patients with active, mild or moderate UC.;Secondary Objective: -To compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of clinical remission in patients with active, mild or moderate UC. -To compare the efficacy of budesonide MMX 9 mg and placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of endoscopic remission in patients with active, mild or moderate UC. - To compare the time to onset of clinical remission in the two treatment groups. - To compare the percentages of patients who achieve clinical improvement in the two treatment groups. - To compare the percentages of patients who achieve histologic healing in the two treatment groups. -To compare the percentages of treatment failures in the two treatment groups. - To evaluate the effects of budesonide MMX 9 mg on the inflammatory bowel disease-quality of life (IBD-QoL) questionnaire, CRP, and fecal calprotectin when compared to placebo.;Primary end point(s): The primary efficacy endpoint is UCDAI (clinical and endoscopic) remission at Day 56, defined as a total UCDAI score (according to the Sutherland index of = 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance.;Timepoint(s) of evaluation of this end point: Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints are as follows: • Clinical remission at Day 56, defined as a score of 0 for rectal bleeding and 0 for stool frequency from the UCDAI • Endoscopic remission at Day 56, defined as a score of 0 from the mucosal appearance subscore from the UCDAI;Timepoint(s) of evaluation of this end point: Day 56 | — |
Countries
Bulgaria, Canada, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Ukraine, United States
Contacts
Public ContactMichael Huang, MD, Medical Director
Santarus, Inc.
Outcome results
None listed