RO7790121 for Eczema

Recruiting at 13 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

Trial Summary

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.

What is the purpose of this trial?

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

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: RO7790121 Group III Experimental Treatment 1 Intervention

Participants will receive RO7790121 via SC injection.

Group II: RO7790121 Group II Experimental Treatment 1 Intervention

Participants will receive RO7790121 via SC injection.

Group III: RO7790121 Group I Experimental Treatment 1 Intervention

Participants will receive RO7790121 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