TRaCkLIGHT study for people with moderate to severe | Clinical Research Studies Listing

TRaCkLIGHT study for people with moderate to severe Crohn's Disease

Recruiting

18 years - 75 years

All

Phase 1

4 participants needed

1 Location

Brief description of study

Patients with moderate to severe Crohn's disease, who have failed prior treatment with the standard anti-TNF therapy will receive the study medication - MDGN-002 - which may help treat the Crohn's disease and relieve its symptoms.

Detailed description of study

The purpose of this research study is to be studying the safety of this drug, including any side effects related to its use and how well the symptoms are tolerated, while also learning if the study drug MDGN-002 might be useful in treating Crohn’s disease and its symptoms. . MDGN-002 is a research therapy that has been tested before in adults using a single dose. MDGN-002 is not yet approved by the United States Food and Drug Administration (FDA).

How long will you be in this study?

If you agree to take part, the treatment period will last for 84 days and will involve upto 12 study visits. Study visits will last between 1 and 8 hours. There will be upto 2 study-related telephone calls.

The total duration of being in the study is about 26 weeks.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Crohn's Disease
Age: 18 years - 75 years
Gender: All

You may be eligible if you:

Male or female, ≥18 to £75 years of age
Have a documented diagnosis of moderate to severe, active CD as evidenced by Simple Endoscopy Score for Crohn’s Disease (SES-CD) score of greater than 7, via endoscopy/colonoscopy and histological confirmation.
Have failed treatment with an approved therapeutic dose of an anti-TNFα monoclonal antibody treatment with either no initial response (primary non-responder) or an initial response to induction with subsequent lost response or an initial response to induction with subsequent lost response (secondary non-responder). Examples of anti-TNFa are REmicade, Humira.

You would not be eligible if you:

Have a diagnosis of Ulcerative or indeterminate colitis

Have a history of or current diagnosis of any cancer

Had a surgical bowel resection within the past 6 months prior to screening or planning any resection in the next six months.

Updated on 19 Feb 2024. Study ID: 830065

Pre-Screener

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