Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Phase 2 Induction Study with Long-Term Extension to Evaluate the Clinical Activity and Safety of Oral NX-13 in Participants with Moderate to Severe Ulcerative Colitis

This UK-based study is exploring a new oral medicine, NX-13, for individuals aged 18 and over who have moderate to severe ulcerative colitis. It's a 'Phase 2' trial, meaning researchers are looking at how well the medicine works and if it's safe. Some participants will receive NX-13, and others a 'dummy' pill (placebo), without knowing which they have. They will take the medicine for a period, and researchers will carefully check changes in their symptoms, such as how often they go to the toilet and any bleeding, using a scoring system. The main goal is to see if NX-13 improves symptoms over 12 weeks and to understand any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Landos Biopharma Inc.

Enrolment target

Start

16 Aug 2023

Ulcerative Colitis

What is this study about?

This study is about a new medicine called NX-13, which is being investigated as a potential treatment for people in the UK living with moderate to severe ulcerative colitis.

Ulcerative colitis is a long-term condition where the lining of the large intestine (colon) becomes inflamed and develops tiny open sores (ulcers). This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. Finding effective treatments is important to help people manage their symptoms and improve their quality of life.

In this study, researchers want to see how well NX-13 works to reduce the symptoms of ulcerative colitis and if it is safe for patients. They will be comparing it to a "placebo," which looks exactly like the actual medicine but contains no active ingredients. This helps researchers understand the true effects of NX-13. Participants will take the medicine for a set period, and doctors will closely monitor their health, symptoms, and any side effects.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It's testing a new oral medicine (NX-13) against a dummy pill.
Participation involves regular clinic visits and close monitoring.
The main goal is to see if NX-13 improves symptoms and is safe.
You won't know if you're getting the medicine or the dummy pill during the study.

Who may be eligible?

This study is looking for adults aged 18 and older who have been diagnosed with moderate to severe ulcerative colitis. Both men and women can take part.

Before joining, you would need to meet certain health criteria to ensure the study is safe and appropriate for you. A doctor on the research team would review your medical history and current health to see if it's a good fit. For example, they'd look at your specific diagnosis and how well your current treatments are working.

There might be other reasons why someone couldn't join, such as other serious health conditions or taking certain medications that could interfere with the study medicine. These will be discussed in detail with the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with moderate to severe ulcerative colitis?
Are you able to attend regular clinic appointments?
Are you interested in trying a new, investigational medicine?
Are you currently in the UK?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for a while. You'll visit the clinic regularly for check-ups, which will likely include physical examinations, blood tests, and possibly some scans or scopes to look at your bowel. You'll be given either the study medicine (NX-13) or a dummy pill (placebo) to take regularly at home. Neither you nor your study doctor will know which you are receiving during the main part of the study. After the initial treatment period, there will be a longer follow-up phase to continue monitoring your health and any long-term effects. The total duration of your participation could extend for quite some time, potentially over a year, with regular appointments to ensure your safety and track your progress.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. A potential benefit is that you could receive a new treatment (NX-13) that might help your ulcerative colitis symptoms, even if we don't know for sure if it will be more effective than existing treatments. However, there's also a chance you could receive the dummy pill. Like all medicines, NX-13 might cause side effects, some of which could be serious. The research team will explain all known side effects and monitor you closely for any new ones. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium
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Unverified
Poland
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Unverified
Italy

Common questions

What is 'Phase 2' of a clinical trial?

Phase 2 is when researchers are looking closely at how well a new medicine works for a specific condition and checking for side effects in a larger group of people than in earlier stages.

What does 'randomized' mean?

It means you're put into a group (either getting the study medicine or the dummy pill) by chance, like flipping a coin. This makes sure the trial is fair.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It helps researchers see if the real medicine has a genuine effect.

Will I know if I'm getting the real medicine or the placebo?

No, during the main part of the study, neither you nor your doctors will know if you're taking NX-13 or the placebo. This is called 'double-blind'.

What is 'ulcerative colitis'?

It's a long-term condition where the lining of your large intestine (colon) becomes inflamed and develops small sores, leading to symptoms like tummy pain and diarrhoea.