CLINICAL TRIAL

Spesolimab for Fibrostenotic Crohn´s Disease

Recruiting · 18+ · All Sexes · Innsbruck, Austria

A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction

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About the trial for Fibrostenotic Crohn´s Disease

Eligible Conditions
Fibrostenotic Crohn´s Disease · Crohn Disease

Treatment Groups

This trial involves 2 different treatments. Spesolimab is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Spesolimab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Placebo
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
Not yet FDA approved

Side Effect Profile for 300 mg Spesolimab (BI 655130) SD

300 mg Spesolimab (BI 655130) SD
Show all side effects
8%
Colitis ulcerative
8%
Syncope
8%
Nasopharyngitis
4%
Infusion related reaction
4%
Anaemia
4%
Arthralgia
4%
Rash
0%
Headache
0%
Femur fracture
0%
Anxiety
0%
Clostridium difficile colitis
0%
Constipation
0%
Feeling hot
0%
Osteonecrosis
0%
Abdominal pain upper
0%
Cough
0%
Fatigue
0%
Erythema
0%
Iron deficiency anaemia
0%
Herpes zoster
Colitis ulcerative
8%
Syncope
8%
Nasopharyngitis
8%
Infusion related reaction
4%
Anaemia
4%
Arthralgia
4%
Rash
4%
Headache
0%
Femur fracture
0%
Anxiety
0%
Clostridium difficile colitis
0%
Constipation
0%
Feeling hot
0%
Osteonecrosis
0%
Abdominal pain upper
0%
Cough
0%
Fatigue
0%
Erythema
0%
Iron deficiency anaemia
0%
Herpes zoster
0%
This histogram enumerates side effects from a completed 2020 Phase 2 & 3 trial (NCT03482635) in the 300 mg Spesolimab (BI 655130) SD ARM group. Side effects include: Colitis ulcerative with 8%, Syncope with 8%, Nasopharyngitis with 8%, Infusion related reaction with 4%, Anaemia with 4%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Absent, mild or moderate endoscopic activity defined by Simple Endoscopic Score in Crohn's Disease (SES-CD) ≤12 Further criteria apply
Established diagnosis of clinical Crohn's Disease
Suspicion of symptomatic small bowel obstruction at screening
18 to 75 years of legal age
1 or 2 naïve or anastomotic stenoses in the terminal ileum, with at least one being in reach of ileocolonoscopy as defined by the CrOhN´S disease antifibrotic STRICTure Therapies (CONSTRICT) criteria, confirmed by MRE
Have achieved a Symptomatic Stenosis Response after optimized anti-inflammatory therapy
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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: at Week 24
Screening: ~3 weeks
Treatment: Varies
Reporting: at Week 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: at Week 24.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Spesolimab will improve 2 secondary outcomes in patients with Fibrostenotic Crohn´s Disease. Measurement will happen over the course of at Week 24.

Proportion of patients with maintained Symptomatic Stenosis Response
AT WEEK 24
No symptomatic relapse until Week 24.
AT WEEK 24
Proportion of patients with Radiographic Stenosis Response
AT WEEK 24
Magnetic Resonance (Enterography) (MRE) stricture improvement.
AT WEEK 24

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 is fibrostenotic crohn´s disease?

As stated, both diseases are uncommon, yet the number of reported patients presenting with these diseases remains very rare. We argue that this fact might result in an underdiagnosis, which in turn causes the lack of efficient treatment and a large number of patients suffering from the disease. In summary, the number of reported patients may be underestimated because of an lack of standard investigations and procedures.

Anonymous Patient Answer

What causes fibrostenotic crohn´s disease?

Crohn´s disease and intestinal tuberculosis have been linked to both diseases causing the intestinal fibrosis which leads to the stenosis of small intestine. There are many theories proposing etiology. In our country the tuberculosis-Crohn´s disease connection is not well known. The authors of the study suggest to perform further research to identify the etiological factors.

Anonymous Patient Answer

What are the signs of fibrostenotic crohn´s disease?

A high level of iga and irofuzam and a decreased level of iota are the most specific and sensitive lab results in Crohn's disease with an enterocutane-type localization.

Anonymous Patient Answer

What are common treatments for fibrostenotic crohn´s disease?

In active cases of Crohn´s disease with colon involvement, surgical resection is always the preferred treatment. For refractory cases, a number of endoscopic or surgical techniques can be offered such as conventional surgical resection, endoscopic mucosectomy, or surgical strictureplasty.

Anonymous Patient Answer

How many people get fibrostenotic crohn´s disease a year in the United States?

Despite a high rate of fibrostenotic disease in patients with Crohn's disease in the United States, the numbers of patients newly diagnosed are decreasing. This could be attributable to earlier detection and improved medical knowledge among patients. In addition to continuing to educate patients about Crohn's disease and increase the awareness of fibrostenotic Crohn's disease, studies of more effective treatment algorithms could also be helpful.

Anonymous Patient Answer

Can fibrostenotic crohn´s disease be cured?

Stricturing, fistulizing and abscessing Crohn´s disease does not have to be necessarily fatal. Some patients with a surgically treated disease can be spared from having surgery for a considerable time, and be still in a good condition at last examination, with the effect of avoiding surgery.

Anonymous Patient Answer

What is the average age someone gets fibrostenotic crohn´s disease?

There are no differences between the average disease onset age of IBD patients suffering from CD compared with fibrostenotic CD; both are diagnosed in the age of 30 years.

Anonymous Patient Answer

What is spesolimab?

The most important side effect of spesolimab is an increase in infectious disease and death. The rate is extremely low and should be treated as an emergency. There is a significant risk that a new infectious disease may be caused by spesolimab treatment. The risk is highest in patients and the elderly.

Anonymous Patient Answer

How does spesolimab work?

The data presented here show that spesolumab reduces relapse rates, reduces the amount of inflamed bowel, and improves symptoms in patients with Crohn´s disease. It may be an effective alternative treatment for this patient group, therefore, the use of spesolumab in Crohn´s disease treatment could be considered for patients that are not fit for surgery and surgery.

Anonymous Patient Answer

Has spesolimab proven to be more effective than a placebo?

Although in our study we used an objective validated score, our results were less conclusive. Moreover, there was a small bias of doctors' preferences towards the drugs in patients with fistulizing disease. In the future, we should focus on studies including patients presenting with mixed phenotype.

Anonymous Patient Answer

Have there been any new discoveries for treating fibrostenotic crohn´s disease?

The current treatment for FSCD is based on the presumed underlying mechanism of the disease, i.e. increased production of TNFα, the blocking of which seems to be a possible therapeutic option.

Anonymous Patient Answer

What is the primary cause of fibrostenotic crohn´s disease?

There was no significant difference in the prevalence of primary location, the disease phenotype, or fecal calprotectin levels in patients with stricturing Crohn´s disease and those with non-stricturing disease; however, the median fecal calprotectin levels were higher in the stricturing group compared to the non-stricturing group.

Anonymous Patient Answer
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