Table of Contents
- Trial overview
- Who is being studied
- What the trials measure
- Trial phases and status
- Key trial details
- Patient glossary
Trial overview
Two authorised Phase 2 clinical trials are investigating Azd7798 in people with Crohn’s disease.[1][2] These studies are looking at both effectiveness and safety, which means they are checking whether the study treatment may help and whether it can be used safely in the study setting.[1][2]
Who is being studied
One trial is enrolling people with Crohn’s disease in general, with a planned enrollment of 193 participants.[1] The other trial is focused on adults with ileal Crohn’s disease who have an ileostomy, and it plans to enroll 31 participants.[2]
Ileal Crohn’s disease means the disease affects the ileum, which is the last part of the small intestine.[2] An ileostomy is a surgical opening that lets waste leave the body into a bag.[2]
What the trials measure
The larger study is evaluating whether Azd7798 can lead to CDAI remission, defined as a Crohn’s Disease Activity Index score below 150.[1] This is a way to measure whether Crohn’s disease becomes less active.[1]
The smaller study is focused on safety and tolerability during repeated doses in the induction period.[2] It measures adverse events, clinical laboratory tests, vital signs, and 12-lead ECGs, which are heart rhythm tests.[2]
Trial phases and status
Both studies are in Phase 2, a stage that usually follows early testing and looks more closely at how well a treatment works while continuing safety checks.[1][2] Both trials are listed as Authorised, which means they have been approved to move forward in the study setting.[1][2]
These are interventional studies, so the researchers are giving a study treatment and comparing it with placebo in at least one of the trials.[1][2] A placebo is a look-alike treatment that does not contain the active study drug.[1][2]
Key trial details
The first trial is titled “A study looking at how effective and safe AZD7798 is in people with Crohn’s disease.”[1] Its brief summary says it is evaluating the efficacy of AZD7798 induction treatment on Crohn’s Disease Activity Index remission.[1]
The second trial is titled “A trial to learn how safe AZD7798 is and how well it works in adults with ileal Crohn’s disease who have an ileostomy.”[2] Its brief summary says it is evaluating the safety and tolerability of repeated doses of AZD7798 in the induction period.[2]
The first trial includes AZD7798 and AZD7798 placebo as study interventions, while the second trial includes AZD7798 and a placebo made from 0.9% saline solution for injection.[1][2]
Patient glossary
- Crohn’s disease: A long-term inflammatory condition of the digestive tract that can cause pain, diarrhea, and other symptoms.
- Remission: A time when disease activity is low or symptoms are much better.
- Induction period: The early treatment period in a study, when researchers look for the first signs of benefit.
- Safety and tolerability: A check of how well people handle the study treatment and what unwanted effects may happen.
- Vital signs: Basic health measurements such as blood pressure, pulse, and temperature.
- ECG: A test that records the heart’s electrical activity.
