Your session is about to expire
← Back to Search
Apraglutide for Graft-versus-Host Disease
Study Summary
This trial is testing a new drug to see if it is safe and effective in treating aGVHD in people who haven't responded to steroids.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 trial • 16 Patients • NCT04699032Trial Design
Find a Location
Who is running the clinical trial?
Media Library
- I have GI issues after a treatment to prevent cancer return.I am 12 years or older and weigh at least 40 kg.I am a man who will avoid fathering children and donating sperm during and for 2 weeks after the trial.My lower GI acute graft-versus-host disease hasn't improved with steroids.I do not have an active, uncontrolled infection or tuberculosis.I am not taking any Janus kinase inhibitors except for RUX currently.I have chronic graft-versus-host disease.I haven't had major belly surgery or serious gut issues in the last 6 months.My liver tests are not normal.I am being treated with SS and RUX, starting them at the same time or RUX up to 72 hours before apraglutide.I have had a stem cell transplant from a donor.I have not had GI tumors in the last 5 years.I have polyps in my colon that have not been removed.I have active inflammation in my digestive system not caused by graft-versus-host disease.My major organs like heart, lungs, liver, and kidneys are functioning well.My cancer returned after a stem cell transplant.I am not on any GVHD treatment except for SS and RUX.I am a man and will use birth control and not donate sperm during and for 2 weeks after the trial.My cancer returned after a stem cell transplant.I haven't taken glutamine, GLP analogs, or ADA in the last 6 months.I have had a stem cell transplant from a donor.I started treatment with SS plus RUX at the recommended dose no more than 5 days ago.My lower GI graft-versus-host disease is not responding to steroids.You are able to give informed consent and agree to follow the details of participation as outlined in the protocol.I am 12 years or older and weigh at least 40 kg. If in Germany, I am 18 or older.
- Group 1: Apraglutide Low Dose
- Group 2: Apraglutide High Dose
- Group 3: Apraglutide Standard Dose
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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 kind of safety measures are in place to protect individuals taking Apraglutide?
"Due to the nature of a Phase 2 trial, where there is pre-existing evidence for safety but not efficacy, Apraglutide earned a score of 2."
What is the size of this research cohort?
"This trial requires 34 participants that fulfill the inclusion criteria. Those looking to enroll can choose between The Winship Cancer Institute Emory University in Atlanta, Georgia or Stanford Cancer Center in Stanford, California."
Is recruitment for this research study still available?
"Clinicaltrials.gov lists the trial as currently enrolling participants, which was initiated on May 25th 2022 and last modified in November of that same year."
In what locations is the trial being conducted?
"Currently, 7 medical centres are accepting patients for this trial. Locations include Atlanta, Stanford and Iowa City among other nearby cities to reduce the travel burden of participating in the study."
Who else is applying?
What state do they live in?
What portion of applicants met pre-screening criteria?
Share this study with friends
Copy Link
Messenger