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Guselkumab for Crohn's Disease (GALAXI Trial)
GALAXI Trial Summary
This trial will test the effects of a new drug, guselkumab, on Crohn's disease. The study will measure the drug's clinical efficacy, safety, and endoscopic efficacy.
GALAXI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowGALAXI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 1027 Patients • NCT03573323GALAXI Trial Design
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Who is running the clinical trial?
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- I have Crohn's disease and haven't responded well to standard or biologic treatments.I have been diagnosed with ulcerative colitis or indeterminate colitis.I have Crohn's disease and haven't responded well to standard or biologic treatments.I have moderate to severe Crohn's disease based on specific health scores.I am a woman who can have children and have tested negative for pregnancy.I haven't taken any Crohn's disease biologics or experimental treatments recently.I have had Crohn's disease for at least 3 months with inflammation in my colon, ileum, or both.My Crohn's disease medication dose has been changing.I have complications from Crohn's disease like blockages or short gut syndrome.
- Group 1: Phase 3 (GALAXI 2 and 3): Group 1 and Group 2 (Guselkumab)
- Group 2: Phase 2 (GALAXI 1): Group 2 (Guselkumab)
- Group 3: Phase 2 (GALAXI 1): Group 4 (Ustekinumab)
- Group 4: Phase 2 (GALAXI 1): Group 3 (Guselkumab)
- Group 5: Phase 3 (GALAXI 2 and 3): Group 3 (Ustekinumab)
- Group 6: Phase 3 (GALAXI 2 and 3): Group 4 (Placebo/Ustekinumab)
- Group 7: Phase 2 (GALAXI 1): Group 5 (Placebo/Ustekinumab)
- Group 8: Phase 2 (GALAXI 1): Group 1 (Guselkumab)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the desired outcome of this research?
"The primary outcome of this trial will be monitored from Baseline to Week 48 and Phase 3: Clinical Response at Week 12 and Endoscopic Response at Week 48. However, other objectives include Phase 3: Clinical Response at Week 4 (defined as Clinical response based on CDAI score.), Phase 3: Clinical Remission at Week 48 (defined as remission based on CDAI score.), or Phase 3: Endoscopic Remission at week 48 (defined as endoscopic remission based on SES-CD score.)."
How is Guselkumab most often employed?
"Guselkumab is the standard medication used to treat adrenal cortex hormone conditions. Additionally, Guselkumab has been shown to be effective in treating other issues like psoriasis, Crohn's disease, and patients who have not responded well to other TNF therapies."
Could you tell us what other drugs have been studied in relation to Guselkumab?
"There are currently 55 clinical trials underway that focus on Guselkumab. Of these active studies, 24 have reached Phase 3 testing. Though the majority of research is based in Gdansk, Pomorskie, there are 4606 total locations running tests for this potential treatment."
Are there still vacancies in this study for people who want to participate?
"This clinical trial is not presently recruiting candidates at this time. The trial was first posted on 4/13/2018 and was most recently updated on 11/9/2022. If you are exploring for other studies, there are presently 258 studies actively recruiting participants with ileocolitis and 55 trials for Guselkumab actively searching for participants."
How many different hospitals are participating in this trial?
"There are 100 running for this trial including Gastroenterology Associates in Baton Rouge, Gastroenterology and Internal Medicine Research Institute (GIRI) in Edmonton, and Pharmaceutical Integrated Research Company in Waterloo, along with other locations."
What is the projected sample size for this research project?
"This particular trial is not enrolling patients at this moment in time. The first posting was on April 13th, 2018 and the last edit was on November 9th, 2022. However, there are currently 258 trials actively recruiting patients with ileocolitis and 55 Guselkumab trials that have open enrolment."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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