Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01532648
• Date of registration: 13/12/2011
• Prospective Registration: Yes
• Primary sponsor: Bausch Health Americas, Inc.
• Public title: Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen
• Date of first enrolment: January 27, 2012
• Target sample size: 510
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01532648
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Canada, Czech Republic, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Russian Federation, Ukraine, United States

Contacts

• Name: Lindsey Mathew
• Affiliation: Bausch Health Companies

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age 18 to 75 years, inclusive.

2. Established diagnosis of UC, based on clinical history, exclusion of infectious
causes, and characteristic endoscopic and histologic findings.

3. Active mild or moderate UC with an ulcerative colitis disease activity index (UCDAI)
score =4 and =10, with a mucosal appearance score of =1, and physician's rating of
disease activity of 1 or 2.

4. Experiencing active UC (flare) despite a therapeutic dose of an oral 5-ASA (for
example, mesalamine =2.4 g/day for =6 weeks prior to randomization, or equivalent). At
screening, photographic evidence of active UC based on mucosal appearance must be
obtained.

5. Women of childbearing potential or men of reproductive potential must be willing to
use an acceptable form of contraception.

6. Able to comprehend the full nature and purpose of the study, including possible risks
and side effects, and also able to comply with all requirements of the study. Must be
able to understand and voluntarily sign an informed consent prior to any study
procedures.

Exclusion Criteria:

1. Limited distal proctitis (from anal verge to 15 centimeters [cm] above the pectineal
line).

2. Severe UC (UCDAI >10 or physician global assessment [PGA] >2), or non-active UC (UCDAI
<4).

3. Infectious colitis or any recent history of infectious colitis (within 30 days of
Screening).

4. Active malignancy or carcinoma in situ within the last 5 years (treated non-melanoma
skin cancers are not exclusionary).

5. 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. Crohn's disease or indeterminate colitis.

8. Known hypersensitivity to budesonide or any ingredients of the budesonide MMX tablets.

9. Active tuberculosis or other active systemic or local bacterial, fungal, or viral
infection.

10. Liver cirrhosis, evident hepatic or renal disease or insufficiency, or significant
impairment of the biohumoral parameters (=2.5*upper limit of normal [ULN] for alanine
aminotransferase, aspartate aminotransferase, gamma-glutamyl transpeptidase, or =2*ULN
for creatinine). Elevations in bilirubin due to benign conditions such as Gilbert's
syndrome are not exclusionary.

11. Severe diseases in other organs or systems.

12. Local or systemic complications or other pathological states requiring therapy with
corticosteroids and/or immunosuppressive agents.

13. Type 1 diabetes.

14. Glaucoma or with a family history of glaucoma in first-degree relatives.

15. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV), according to
the local privacy policy.

16. Severe anemia (<9 g/deciliter [dL] hemoglobin), leukopenia (<2.5*10^9 white blood
cells [WBC]/liter [L]), or granulocytopenia (<1.2*10^9 cells/L).

17. Participants 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
[that is, 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 budesonide MMX treatment.

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 (TNFa) agents or other biologic therapies
within the last 3 months prior to randomization.

23. Participation in experimental therapeutic studies within 30 days of randomization (or
within the last 3 months if in an anti-TNFa or biologic agent study). Note:
participants 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 participant
or obscure the interpretation of adverse events (AEs) by the appropriate independent
ethics committee/institutional review board.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Placebo

Drug: Budesonide MMX®

Drug: 5-ASA

Primary Outcome(s)

Number of Participants Who Achieved Clinical Remission at Day 56 [Time Frame: Baseline up to Day 56]

Secondary Outcome(s)

Number of Participants Who Achieved Endoscopic Remission at Day 56 [Time Frame: Screening and Day 56]

Number of Participants Who Achieved Histologic Healing at Day 56 [Time Frame: Baseline and Day 56]

Number of Participants of Who Achieved Clinical Response at Day 56 [Time Frame: Baseline up to Day 56]

Number of Participants With Treatment Failure at Day 56 [Time Frame: Baseline up to Day 56]

Change From Baseline in Inflammatory Bowel Disease-Quality of Life (IBD-QoL) Questionnaire Scores [Time Frame: Baseline, Days 14, 28, and 56]

Number of Participants Who Achieved UCDAI Remission at Day 56 [Time Frame: Baseline up to Day 56]

Secondary ID(s)

C2011-0401

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/09/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01532648