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

  • STATUS
    Recruiting
  • participants needed
    4
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Updated on 19 February 2024

Summary

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.

Description

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. 



FAQ

For additional information, please contact the study coordinator Rupa Chowdary at Rupa.chowdary@pennmedicine.upenn.edu or 215-573-5073

Details
Condition Crohn's Disease
Age 18years - 75years
Clinical Study IdentifierNCT03169894
Last Modified on19 February 2024

Eligibility

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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