RecruitingPhase IInterventional

Safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ANB033 - Part 1c

This study is looking into a new treatment called ANB033 for people with Eosinophilic Esophagitis (EoE), a condition where the immune system overreacts and causes problems in the food pipe. ANB033 is a medicine given by injection under the skin, designed to calm down these overactive immune cells. This early-stage study (Phase 1) will check if ANB033 is safe and well-tolerated by adults with EoE and how their bodies handle the medicine. Participants will receive either ANB033 or a placebo, like tossing a coin. By joining, you could help scientists learn more about this potential new medicine, which might benefit others with similar conditions in the future. The study is running in several countries, including the UK, and is expected to finish in late 2027.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

AnaptysBio, Inc.

Enrolment target

Start

28 Feb 2026

Estimated completion

28 Feb 2027

Eosinophilic Esophagitis (EoE)

What is this study about?

This study is focused on a new medicine called ANB033, which is being developed as a possible treatment for conditions involving an overactive immune system, like Eosinophilic Esophagitis (EoE). EoE is when your body's defence system mistakenly attacks your own cells in the food pipe (oesophagus), causing inflammation and making it hard to swallow. We believe ANB033 could help by calming down these overactive immune cells and restoring a healthier balance in your body's defences. It's given as an injection just under the skin.

The main goal of this early-stage study (called Phase 1) is to find out if ANB033 is safe for adults with EoE and how well their bodies tolerate it. We also want to understand how the body absorbs, processes, and gets rid of the medicine. This is important information to gather before we can test if the medicine actually treats the condition effectively in future studies.

Taking part in this study won't necessarily cure your condition, but your involvement is really important. It will help us gather vital scientific knowledge that could lead to ANB033 becoming a new treatment option for people with EoE and similar conditions in the future. This study is being carried out in different hospitals across several countries, including the UK, and is planned to run until late 2027.

Key takeaways

This study is testing a new medicine (ANB033) for Eosinophilic Esophagitis (EoE).
It aims to check the safety and how the body handles ANB033 in adults with EoE.
Participants will receive ANB033 or a placebo, given by injection under the skin.
Your involvement helps advance scientific knowledge for future treatments, but may not benefit you directly.
The study involves clinic visits and is expected to run until late 2027.
You can stop participating at any time.

Who may be eligible?

This part of the study is looking for men and women between 18 and 70 years old who have been diagnosed with Eosinophilic Esophagitis (EoE). To be considered, your EoE diagnosis must have been confirmed by a doctor, usually through a biopsy of your food pipe.

There are also specific medical details that apply. For example, your EoE symptoms, like difficulty swallowing, need to meet certain requirements. You also shouldn't have responded to a past treatment (proton pump inhibitors, or PPIs) or couldn't take them. There are other health conditions or lifestyle factors, like recent smoking or being very underweight or overweight, that might prevent you from joining to ensure the study is safe for everyone involved.

Women who are pregnant or breastfeeding cannot take part. If you're a woman, you must not be pregnant or breastfeeding. If you're a man, you must agree to use specific contraception methods during the study. It's important that you also feel able to come to all the required study appointments and follow the study instructions.

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 between 18 and 70 years old?
Do you have a confirmed diagnosis of Eosinophilic Esophagitis (EoE)?
Have you not responded to standard PPI treatments, or are you unable to take them?
Do you experience difficulty swallowing (dysphagia) at least 4 times in a two-week period?
Are you able to attend all required study appointments and follow instructions?
Are you not currently pregnant or breastfeeding (for women), or willing to use specific contraception (for men)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance (like flipping a coin) to receive either the study medicine, ANB033, or a 'placebo', which looks like ANB033 but contains no active medicine. This is a common way to test new medicines fairly. Both the study team and you won't know which one you're receiving.

The medicine will be given as an injection under the skin. The study will involve several visits to the clinic for assessments. These will include check-ups to monitor your safety, blood tests to see how your body is handling the medicine, and other tests related to your EoE condition. The full details of the schedule will be explained to you before you agree to take part. The study is planned to start in January 2026, and the last participant's final visit is expected to be in November 2027.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. The main benefit of joining this study is that you would be contributing to important scientific research. Your participation could help us understand if ANB033 might become a new treatment for EoE in the future, potentially helping many other people with the condition. It's important to know that you might not personally benefit directly from receiving the study medicine, as you could be given the placebo. As with any new medicine, there's always a possibility of unknown side effects or reactions, and these will be carefully monitored by the study team. You are completely free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (1)

Royal Liverpool University Hospital
Approximate
Liverpool, England

Common questions

What is Eosinophilic Esophagitis (EoE)?

EoE is a long-term condition where a type of white blood cell, called eosinophils, builds up in the food pipe, causing inflammation and making it hard to swallow.

What is ANB033?

ANB033 is a new medicine being tested. It's an 'investigational monoclonal antibody' designed to calm down overactive immune cells that cause conditions like EoE.

How will I take the medicine?

The medicine (ANB033 or placebo) will be given as an injection just under your skin.

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

No, neither you nor the study doctors will know if you're receiving ANB033 or the placebo. This helps us get fair and unbiased results.

Where is the study taking place in the UK?

This is a global study, including sites in the UK. Specific clinic locations will be discussed with you if you are eligible.

How to find out more

Lewis Gryziewicz

clinicaltrialinfo@anaptysbio.com +1 (0)4042746330 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.