RO7790121 for Eczema

Recruiting at 68 trial locations

Overseen By Reference Study ID Number: CS45570 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Must not be taking: Corticosteroids, Calcineurin inhibitors

Disqualifiers: Other skin conditions, Active infection, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Afimkibart (also known as RO7790121) for individuals with moderate to severe eczema, also known as atopic dermatitis. The goal is to evaluate the treatment's effectiveness and ensure its safety. Participants will receive injections of either Afimkibart or a placebo, a harmless substance resembling the treatment. This trial suits those with a dermatologist-confirmed eczema diagnosis for at least a year who use a simple, additive-free moisturizer daily. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in eczema care.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must stop using oral and injectable corticosteroids, certain topical treatments for eczema, and systemic therapies like methotrexate and cyclosporine at least 4 weeks before the study starts and during the study.

Is there any evidence suggesting that RO7790121 is likely to be safe for humans?

Research has shown that Afimkibart (RO7790121) is under study to determine its safety and effectiveness in treating atopic dermatitis, also known as eczema. Participants have generally tolerated Afimkibart well. In these studies, most side effects were mild to moderate, with the most common being skin reactions at the injection site and mild infections.

Few reports of serious side effects suggest the treatment might be safe for most people. However, as the treatment is still under investigation, researchers continue to gather more information about its safety. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

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

Researchers are excited about RO7790121 for eczema because it offers a potentially novel approach compared to existing treatments like topical steroids and immunosuppressants. Unlike these standard treatments, RO7790121, also known as afimkibart, is administered via subcutaneous injection, which could provide longer-lasting effects with less frequent dosing. Additionally, afimkibart may target specific pathways in the immune system differently, potentially reducing inflammation more effectively and with fewer side effects. This could lead to improved outcomes for patients who have not responded well to traditional therapies.

What evidence suggests that RO7790121 might be an effective treatment for eczema?

Research has shown that Afimkibart (RO7790121) might help treat moderate to severe atopic dermatitis, commonly known as eczema. Early results suggest this treatment can reduce skin inflammation and irritation. It targets specific parts of the immune system that cause eczema flare-ups, potentially leading to clearer skin and less itching. Previous studies on similar treatments have shown promising results, with many patients experiencing significant improvements in their symptoms. While more research is needed to confirm these effects for Afimkibart specifically, the early signs are encouraging. Participants in this trial will receive Afimkibart in one of several experimental groups or a placebo to further evaluate its effectiveness. ^{1 2 3 4 5}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with moderate to severe atopic dermatitis (AD), confirmed by a dermatologist. Participants should have been diagnosed at least one year ago and must use an additive-free emollient daily for a week before starting the study.

Inclusion Criteria

Moderate to severe AD

I have used a simple moisturizer every day for at least a week.

AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening

Exclusion Criteria

I have a weakened immune system from birth or due to a condition.

I haven't taken strong steroids by mouth or injection recently.

I haven't needed strong antibiotics for infections or skin conditions in the last month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive RO7790121 or placebo via subcutaneous injection

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7790121

Trial Overview The trial is testing RO7790121, which is being compared to a placebo to see if it's effective and safe in treating AD. Participants will be randomly assigned to receive either the actual medication or a placebo.

How Is the Trial Designed?

Group I: Afimkibart Group III Experimental Treatment 1 Intervention

Participants will receive afimkibart via SC injection.

Group II: Afimkibart Group II Experimental Treatment 1 Intervention

Participants will receive afimkibart via SC injection.

Group III: Afimkibart Group I Experimental Treatment 1 Intervention

Participants will receive afimkibart via subcutaneous (SC) injection.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive placebo via SC injection.

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

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06863961

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 ...

2. forpatients.roche.com forpatients.roche.com/en/trials/autoimmune-disorder/atopic-dermatitis/a-study-to-assess-the-efficacy-and-safety-of-ro7790121--62648.html

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 ...

3. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/atopic-dermatitis/a-long-term-extension-study-to-evaluate-the-safety-and--63775.html

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 ...

4. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/580699

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07223697

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 ...