Active not recruitingPHASE2INTERVENTIONAL

A Study to Assess the Efficacy and Safety of Afimkibart (RO7790121) in Participants With Moderate to Severe Atopic Dermatitis

This research study is looking at a new medicine called Afimkibart (also known as RO7790121) for adults living with moderate to severe atopic dermatitis, more commonly known as eczema. Many people with eczema find their current treatments aren't enough, so researchers are always looking for new options. The main goal of this study is to find out if Afimkibart is both safe to use and effective at improving symptoms of eczema. To do this, some participants will receive the new medicine, while others will receive a 'placebo' – a dummy treatment that looks just like the real medicine but contains no active ingredients. This helps researchers accurately see the effects of Afimkibart. This is a Phase 2 study, which means it's an important step in understanding how well the medicine works before it can be considered for wider use.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

160

Start

01 Apr 2025

Estimated completion

03 Feb 2027

Atopic Dermatitis

What is this study about?

If you or someone you know lives with eczema (atopic dermatitis), you'll know how challenging it can be. Eczema can cause itchy, dry, and inflamed skin, and for some, it can be quite severe. Current treatments help many people, but there's always a need for new and better options.

This study is investigating a new medicine called Afimkibart. It's designed for people whose eczema is moderate to severe, meaning it significantly affects their daily life. Researchers want to carefully examine if this new medicine can reduce eczema symptoms and improve the overall skin condition. They also want to understand if it has any side effects, which is just as important as knowing if it works.

To get clear and reliable results, the study will compare Afimkibart with a 'placebo.' A placebo looks exactly like the actual medicine but doesn't contain any active ingredients. This allows the researchers to accurately determine if any improvements seen are truly due to Afimkibart or if they might be a result of other factors. This type of study design is standard in medical research to ensure the findings are as precise as possible. It's important to remember that this is a Phase 2 study, which means it's still in the earlier stages of development.

Key takeaways

This study is for adults with moderate to severe eczema.
It's testing a new medicine called Afimkibart for safety and effectiveness.
Some participants will receive the new medicine, others a dummy treatment (placebo).
It's a Phase 2 study, an early step in medicine development.
You'll need regular clinic visits and careful monitoring if you take part.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with eczema by a dermatologist at least a year ago and whose eczema is considered moderate to severe.

To join, you'll need to be regularly using a basic, unscented moisturiser every day for at least a week before the study starts and continue doing so throughout. You won't be able to join if you have other skin conditions that might make it hard to tell if the eczema is improving, or if you've recently used certain strong medicines for your eczema or other conditions, like oral steroids or strong topical treatments. Also, if you have a weakened immune system or an active infection, you won't be able to take part for your safety.

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?
Has a skin doctor (dermatologist) confirmed you have eczema at least one year ago?
Is your eczema moderate to severe?
Are you able to use a basic, unscented moisturiser daily for the study?
Have you avoided other strong eczema treatments (like oral steroids or certain medicated creams) recently?
Do you have a healthy immune system and no active infections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have several visits to the study clinic over a certain period. During these visits, the study team will carry out checks to see how your skin is doing, take blood samples, and ask you about your symptoms and how you're feeling. You'll be given either the new study medicine, Afimkibart, or a placebo (a dummy treatment) to take regularly, as instructed by the study team.

Throughout the study, you'll be carefully monitored. You'll need to avoid using certain other eczema treatments, such as strong steroid creams or oral medications, to ensure that any changes are due to the study medicine. The total length of your participation will be explained to you by the study team if you're interested in joining.

Potential risks and benefits

Participating in this study might offer you the potential benefit of trying a new medicine that could improve your eczema symptoms. However, as with all new medicines, there's a possibility of side effects, and the medicine might not work for everyone. These side effects could range from mild to more serious, and the study team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (68)

First OC Dermatology
Verified postcode
Fountain Valley, United States
The Center for Dermatology Clinical Research
Verified postcode
Fremont, United States
University of California Los Angeles
Verified postcode
Los Angeles, United States
Dermatology Research Associate
Verified postcode
Los Angeles, United States
Suncoast Research Associates LLC - ERN - PPDS
Verified postcode
Doral, United States
Olympian Clinical Research
Verified postcode
Tampa, United States
Hamilton Research, LLC
Verified postcode
Alpharetta, United States
Dermatology Affiliates Research Institute, LLC
Verified postcode
Atlanta, United States
Dawes Fretzin Clinical Res LLC
Verified postcode
Indianapolis, United States
Southern Indiana Clinical Trials
Verified postcode
New Albany, United States
Revival Research Institute, LLC
Verified postcode
Troy, United States
Regents of the University of Minnesota
Verified postcode
Minneapolis, United States

Common questions

What is eczema (atopic dermatitis)?

Eczema is a common, long-term condition that causes the skin to become dry, itchy, red, and cracked. It can sometimes be quite uncomfortable and affects people differently.

What is a 'placebo'?

A placebo is a dummy treatment. It looks exactly like the medicine being tested but contains no active ingredients. This helps researchers compare the real medicine's effects accurately.

What is a Phase 2 study?

A Phase 2 study is an early stage of clinical research. It mainly focuses on assessing whether a new treatment is safe and if it shows some signs of being effective for a particular condition.

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

No, during the study, neither you nor the study team will know whether you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure unbiased results.

Can I continue my usual eczema creams during the study?

You will need to use a basic, unscented moisturiser. However, you will need to stop using certain strong eczema treatments like steroid creams, calcineurin inhibitors, or certain prescription moisturisers for a period before and during the study.