CLINICAL TRIAL

Brazikumab low dose for Ileocolitis

Stage I
Recruiting · 18+ · All Sexes · Montpellier Cedex 5, France

This study is evaluating whether brazikumab is safe and effective in treating people with CD.

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About the trial for Ileocolitis

Eligible Conditions
Crohn's Disease (CD) · Inflammatory Bowel Diseases (IBD) · Crohn Disease

Treatment Groups

This trial involves 6 different treatments. Brazikumab Low Dose is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Experimental Group 1
Brazikumab high dose
DRUG
Experimental Group 2
Brazikumab low dose
DRUG
Experimental Group 3
Brazikumab low dose
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Endoscopic response at Week 12, endoscopic remission at Week 52
Screening: ~3 weeks
Treatment: Varies
Reporting: Endoscopic response at Week 12, endoscopic remission at Week 52
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Endoscopic response at Week 12, endoscopic remission at Week 52.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether Brazikumab low dose will improve 32 secondary outcomes in patients with Ileocolitis. Measurement will happen over the course of at Week 12.

Stage 1. Serum IL-22 concentration clinical cutoff for Stage 2
AT WEEK 12
Derive the relationship between baseline serum IL-22 concentration and efficacy of brazikumab through CDAI remission and endoscopic response
AT WEEK 12
Stage 2. Percentage of patients with endoscopic response
AT WEEK 12
Endoscopic response is described as minimum of 50% decrease from Baseline in SES-CD total score
AT WEEK 12
Stage 2. Percentage of patients with CS-free clinical remission
AT WEEK 52
Percentage of patients achieving CS-free average daily LSF subscore of ≤ 3 as assessed on the CDAI LSF item AND average daily AP subscore of ≤ 1 as assessed on the CDAI AP item
AT WEEK 52
Stage 2: Percentage of patients with CS-free endoscopic remission
AT WEEK 52
For participants taking CS at Baseline, percentage of patients achieving CS-free endoscopic remission
AT WEEK 52
Stage 2: Percentage of patients with endoscopic remission
AT WEEK 52
Endoscopic remission: - SES-CD total score of 0-2, OR - SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
AT WEEK 52
Stage 1. Percentage of patients with endoscopic remission
AT WEEK 52
Endoscopic remission is defined as achieving the SES-CD total score of 0-2 OR SES-CD total score of ≤ 4 and at least 2 point reduction from Baseline with no subscore > 1
AT WEEK 52
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes ileocolitis?

Ileocolitis can result from a complicated interaction of the immune and digestive systems or from a primary digestive disease such as Crohn's disease. The main causes in adults are unknown and the diagnosis usually is based on colonoscopy and biopsy. Most sufferers have no evidence of a previous diagnosis and are treated based on empirical therapy for one year. The exact cause is unknown and treatment options are limited so that the most appropriate therapy can be obtained and the condition is best managed.

Anonymous Patient Answer

What are common treatments for ileocolitis?

Most common treatments for ileocolitis include discontinuing any oral or parenteral food, using probiotics and antibiotics as the last resort, or a combination of the above. Surgery is not an option in ileocolitis, and all patients are managed symptomatically.

Anonymous Patient Answer

What is ileocolitis?

The inflammatory bowel disease with two types of cancer, colitis and Crohn's disease, is more related to an increase in colon carcinogenesis than to a decrease in colon carcinogenesis.

Anonymous Patient Answer

How many people get ileocolitis a year in the United States?

The incidence of ileocolitis is low in the U.S. in contrast to Denmark, where one tenth of all patients with Crohn's disease need to be treated with systemic corticosteroids each year. The low incidence in Denmark may be explained by the fact that only patients who need systemic corticosteroids are admitted to hospital for a colostomy or colectomy. The high incidence of ileocolitis in Denmark may perhaps be caused by a larger use of systemic corticosteroids in both patients with Crohn's disease and ulcerative colitis, since the use of corticosteroids is not restricted to patients with ileocolitis.

Anonymous Patient Answer

Can ileocolitis be cured?

Patients with severe ileocolitis are at risk of perforation. However, ileic pouch surgery with diversionary ileostomy can be offered to patients with disabling disease who are not candidates for pouch substitution surgery. The use of ileostomy in a subset of pouch surgery patients can be associated with some reduction in the rate of pouch-related complications and hospital admissions.

Anonymous Patient Answer

What are the signs of ileocolitis?

To rule out inflammatory bowel disease, physicians must consider symptoms such as diarrhea, rectal bleeding, anemia, and abdominal distension. Also, an ileocecal valve of >30 cm can be an indicator of ileocolitis. When evaluating a patient for inflammatory bowel disease, physicians should consider a workup of colonic and fecal examinations, stool histologic examination, evaluation of inflammatory indices, and evaluation of inflammatory bowel disease-specific tests.

Anonymous Patient Answer

Does brazikumab low dose improve quality of life for those with ileocolitis?

There was no statistical difference between groups after the 1-month follow-up in scores for SISSI-FI and IBS symptom improvement or quality of life as perceived by patients. A large placebo effect is assumed in clinical trials of medications (in this case, a subgroup of patients with a severe form of ileocolitis were treated by the placebo only).

Anonymous Patient Answer

What is the average age someone gets ileocolitis?

In a recent study, findings has quantified the mean age of onset for IC. There was no statistical difference for males or females as well as right- and left-side onset as seen in other studies. Younger individuals have a longer onset of IC than those diagnosed with age.

Anonymous Patient Answer

What are the latest developments in brazikumab low dose for therapeutic use?

Therapeutic brazikumab 20 mg was well tolerated and efficacious in the treatment of pouchitis and pouch failure. The use of brazikumab in the treatment of pouchitis may be comparable or superior to conventional therapy with oral metronidazole or methotrexate, although a randomized comparative study is needed.

Anonymous Patient Answer

Is brazikumab low dose safe for people?

The dose of B-ABZ used in the present study was found to be safe and effective. Given a higher incidence of adverse events with higher rates observed in the placebo arm after two years, a study on a longer duration of follow up would be warranted. However, this prospective study was only a pilot study and a full-scale study with an extended data collection period is required in order to establish safety and efficacy of B-ABZ.

Anonymous Patient Answer

Who should consider clinical trials for ileocolitis?

While most patients with colitis are treated surgically with one of the medications used in the clinical trials, the clinical trials and their data are the basis for this treatment. In this review we have only highlighted the most relevant trials and have not covered all of the ileocolitis trials. We hope that this review will lead to the inclusion of more trials investigating this area of chronic gut disease and the advancement of therapy.

Anonymous Patient Answer

Does ileocolitis run in families?

Recent findings showed no evidence for an increased risk of IBD in families with other members with a similar phenotype, suggesting that an autoimmune mechanism is unlikely to be responsible for susceptibility in these families.

Anonymous Patient Answer
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