120 Participants Needed

Afimkibart for Atopic Dermatitis

(Velarite-LTE Trial)

RS
Overseen ByReference Study ID Number: CS45943 https://forpatients.roche.com/
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Afimkibart for individuals with atopic dermatitis, a common form of eczema that causes itchy and inflamed skin. The goal is to assess the long-term safety and effectiveness of Afimkibart. Individuals who participated in earlier Afimkibart trials and experienced improvement might be suitable candidates. Participants will receive the treatment via an injection under the skin. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Afimkibart is likely to be safe for humans?

Research shows that Afimkibart, tested on people with moderate to severe atopic dermatitis, has promising safety results. Previous studies found that most participants tolerated the treatment well. Some mild side effects, such as redness at the injection site or mild headaches, were noted, but these were not serious for most people. The treatment remains under study, with its safety closely monitored. Participants from earlier trials provided valuable information, enhancing the understanding of the treatment's safety.12345

Why do researchers think this study treatment might be promising for atopic dermatitis?

Afimkibart is unique because it targets atopic dermatitis in a novel way. Unlike traditional treatments like topical corticosteroids or calcineurin inhibitors, which mainly focus on reducing inflammation on the skin's surface, Afimkibart is administered as a subcutaneous injection, potentially offering more systemic relief. Researchers are excited about Afimkibart because it promises a new mechanism of action, possibly leading to improved outcomes for patients who haven't responded well to existing therapies. This innovative approach could provide a more effective long-term solution with fewer side effects.

What evidence suggests that Afimkibart might be an effective treatment for Atopic Dermatitis?

In earlier studies, Afimkibart showed promise in treating moderate to severe atopic dermatitis. Research shows that participants experienced a noticeable reduction in symptoms like itching and skin inflammation after receiving the treatment. This improvement suggests Afimkibart can enhance the quality of life for people with this condition. Initial findings also indicate it may be safe and effective for long-term use. These results offer hope for its use as a treatment option for atopic dermatitis.12345

Who Is on the Research Team?

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for individuals with Atopic Dermatitis who were part of the CS45570 study, saw at least a 50% improvement by Week 36, and can commit to protocol requirements like efficacy assessments and safety checks throughout the study.

Inclusion Criteria

I was part of study CS45570, saw improvement by Week 36, and my condition improved by 50% or more from the start.
I can follow the study's requirements and attend all appointments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Afimkibart as a subcutaneous injection

Follow-up

Participants are monitored for long-term safety and efficacy of Afimkibart

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Afimkibart

Trial Overview

The long-term safety and effectiveness of Afimkibart (RO7790121) are being evaluated in patients with Atopic Dermatitis who have previously participated in Afimkibart clinical trials.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Afimkibart Group IIExperimental Treatment1 Intervention
Group II: Afimkibart Group IExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

NCT06863961 | A Study to Assess the Efficacy and Safety ...

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic ...

Clinical trial for Atopic Dermatitis-Genentech A Member o...

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in ...

Clinical trial for Atopic Dermatitis-ForPatients by Roche

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic dermatitis ...

A Long Term Extension Study to Evaluate the Safety and ...

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in ...

A Study to Assess the Efficacy and Safety of Afimkibart ...

The purpose of this study is to assess the efficacy and safety of Afimkibart (also known as RO7790121) in participants with moderate to severe atopic ...