Budesonide for Pediatric Ulcerative Colitis

Recruiting at 4 trial locations

Overseen By Sandra Narain

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

Must be taking: 5-ASA

Disqualifiers: Crohn's disease, Severe UC, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests budesonide, a medication, to determine if it helps children with mild to moderate ulcerative colitis achieve remission, meaning their symptoms disappear. The trial compares high and low doses of budesonide against a placebo to assess its effectiveness and safety. Children aged 5 to 17 with active ulcerative colitis and symptoms like rectal bleeding or frequent stools might be suitable candidates. As a Phase 4 trial, budesonide is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Do I need to stop my current medications for the trial?

You can continue taking your current oral or rectal 5-aminosalicylate (5-ASA) medications, but the dose and type must stay the same as they have been for at least 6 weeks before starting the trial.

What is the safety track record for budesonide?

Research shows that budesonide is generally well-tolerated by people with ulcerative colitis. Studies with adults have found that budesonide causes fewer steroid-related side effects compared to similar drugs, suggesting it might be a safer option for treating inflammatory bowel conditions.

Budesonide is already approved for treating other conditions like Crohn's disease and eosinophilic esophagitis, an allergic inflammation in the esophagus. This approval supports its safety profile.

However, like any medication, budesonide can have side effects. Common ones include headaches, nausea, and fatigue. It's important to weigh these possible effects against the potential benefits when considering participation in a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Budesonide is unique for treating pediatric ulcerative colitis because it offers a targeted approach with potentially fewer side effects. Unlike standard treatments like mesalamine or corticosteroids, which can affect the entire body, budesonide is designed to release directly in the gut, minimizing systemic exposure. This targeted delivery not only helps in reducing inflammation more effectively but also decreases the risk of side effects that are common with other treatments. Researchers are excited about budesonide because it might offer a safer, more efficient option for young patients, providing relief while allowing them to maintain a good quality of life.

What evidence suggests that budesonide might be an effective treatment for pediatric ulcerative colitis?

Research has shown that budesonide effectively treats ulcerative colitis (UC). In earlier studies, nearly half of the patients taking budesonide experienced significant symptom improvement or resolution. Specifically, 77.7% of children with UC showed significant improvement after four weeks of treatment. In this trial, participants will receive either a high dose or low dose of budesonide, or a placebo. Budesonide has proven more effective than a placebo, indicating its effects are not merely due to patients' expectations. This treatment releases the medicine directly in the colon, helping to reduce inflammation and improve symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Varsha Bhatt

Principal Investigator

Bausch Health

Are You a Good Fit for This Trial?

This trial is for kids aged 5-17 with mild to moderate ulcerative colitis, a type of inflammatory bowel disease. They must have specific symptoms and an established diagnosis based on medical history and tests. Kids should weigh over 13.6 kg and can continue their usual oral or rectal anti-inflammatory medication if stable for at least 6 weeks.

Inclusion Criteria

I have been diagnosed with ulcerative colitis based on my medical history, colonoscopy, and biopsy results.

My ulcerative colitis is active but not severe, with symptoms like bleeding, frequent stools, and visible inflammation.

I have been on the same 5-ASA medication for at least 6 weeks and am willing to stay on it.

Exclusion Criteria

My ulcerative colitis is severe, with a Mayo score over 10.

I have not had infectious colitis or a positive test for it in the last 30 days.

I have had gastrointestinal surgery, but not for appendicitis or hernia. A gallbladder removal over a year ago is okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive budesonide extended-release tablets or placebo for the induction of remission in pediatric subjects with active, mild to moderate ulcerative colitis

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Budesonide
• Placebo

Trial Overview The study is testing the effectiveness of budesonide extended-release tablets in inducing remission in children with ulcerative colitis. It's a randomized trial comparing two doses of budesonide against a placebo while allowing continued use of standard anti-inflammatory drugs.

How Is the Trial Designed?

Group I: Low Dose Budesonide Experimental Treatment 1 Intervention

Group II: High Dose Budesonide Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Budesonide is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Pulmicort for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis
• Crohn's disease
• Ulcerative colitis
• Microscopic colitis
• Eosinophilic esophagitis
• Primary immunoglobulin A nephropathy

Approved in United States as Entocort EC for:

• Crohn's disease
• Ulcerative colitis
• Primary immunoglobulin A nephropathy
• Eosinophilic esophagitis

Approved in Canada as Pulmicort for:

• Asthma
• Chronic obstructive pulmonary disease (COPD)
• Allergic rhinitis

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6826517/

Use, effectiveness and tolerability of budesonide-MMX in ... Clinical remission was achieved in 41 out of 82 patients (50%) and clinical response in two patients (2.4%), whereas no response was reported in ...

2. academic.oup.com academic.oup.com/ecco-jcc/article-abstract/11/11/1402/3826693

Budesonide MMX in Paediatric Patients With Ulcerative Colitis The authors included in their study an impressive number of 510 adult patients. Based on the results, they stated that budesonide MMX is safe and efficacious ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1873994609001032

Preliminary efficacy and safety study of a new Budesonide ... After 4 weeks, 47.1% of the patients in the Budesonide-MMX® 9 mg tablets group achieved the primary end-point vs. 33.3% of patients on placebo. In addition, ...

4. cabidigitallibrary.org cabidigitallibrary.org/doi/full/10.5555/20163223438

Budesonide MMX in pediatric ulcerative colitis. Mean PUCAI score at baseline: 45 points. After 4 weeks of therapy 7 patients (77.7%) achieved clinical remission and continued it up to 8 week. After that time ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085(12)01186-9/fulltext

Once-Daily Budesonide MMX® Extended-Release Tablets ... Budesonide MMX (9 mg) was safe and more effective than placebo in inducing remission in patients with active, mild to moderate UC. ClinicalTrials.gov, Number: ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/budesonide-oral-route/description/drg-20073233

Budesonide (oral route) - Side effects & dosage Budesonide extended-release tablets are used to help get active mild to moderate ulcerative colitis under control (induce remission). Budesonide ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9239584/

Oral budesonide for induction of remission in ulcerative colitis Fifteen per cent (71/462) of budesonide‐MMX® 9 mg patients achieved remission compared to 7% (30/438) of placebo patients (RR 2.25, 95% CI 1.50 to 3.39). A ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5777428/

Comparative safety of systemic and low‐bioavailability ... Budesonide MMX is associated with fewer corticosteroid‐related AEs than its comparator steroid treatments for adult IBD patients.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jpn3.70245

Drugs in focus: Budesonide and its role in paediatric ... Budesonide is indicated for various GI disorders, including Crohn's disease (CD, ulcerative colitis (UC) and eosinophilic oesophagitis (EoE), ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2444382418301354

Reviewing the therapeutic role of budesonide in Crohn's ... Budesonide (BUD) is the only recognised pharmacological alternative for the treatment of mild, active ileal or ileocolic Crohn's disease (CD).