TRaCkLIGHT study for people with moderate to severe Crohn's Disease
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: Between 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
26 Jul 2021.
Study ID: 830065
