Assessing a new treatment for moderate to severe atopic dermatitis
A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of RO7790121 in Patients With Moderate to Severe Atopic Dermatitis
This study is testing a new medication for people with moderate to severe atopic dermatitis to see if it can help improve their skin condition compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hoffmann-La Roche Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT06863961 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of a new medication, RO7790121, in individuals diagnosed with moderate to severe atopic dermatitis. Participants will be monitored for their response to the treatment compared to a placebo over a specified period. Inclusion criteria require a confirmed diagnosis of atopic dermatitis and consistent use of a bland emollient prior to the study. The study aims to determine if RO7790121 can provide significant improvements in managing this chronic skin condition.
Who should consider this trial
Good fit: Ideal candidates are individuals with a confirmed diagnosis of moderate to severe atopic dermatitis who have been using a bland emollient regularly.
Not a fit: Patients with other skin conditions that may interfere with the assessment of atopic dermatitis or those currently using certain prohibited treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from moderate to severe atopic dermatitis.
How similar studies have performed: Other studies have shown promise with similar approaches in treating atopic dermatitis, but the specific efficacy of RO7790121 remains to be established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * AD diagnosis confirmed by a dermatologist according to the Hanifin/Rajka criteria at least 1 year prior to screening * Moderate to severe AD * At least once daily use of an additive-free, bland emollient for at least 7 days prior to the baseline visit and during the study Exclusion Criteria: * Evidence of other skin conditions that would interfere with the assessment of AD, including, but not limited to, for example cutaneous T-cell lymphoma, allergic contact dermatitis * IV, IM, IL, and oral corticosteroids (inhaled, ophthalmic drops, and nasal corticosteroids are allowed) within 4 weeks of the baseline visit and during the study * Topical treatment for AD including, but not limited to topical corticosteroids, topical calcineurin Inhibitors, topical PDE-4 inhibitors, , prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea or filaggrin within 7 days prior to the baseline visit and during the study * Any active infection or other active skin diseases that required treatment with parenteral anti-infectives within 4 weeks or oral anti-infective treatment within 2 weeks prior to baseline * Acquired or congenital immunodeficiency * Systemic therapies that are also used in the treatment of AD, including, but not limited to methotrexate, cyclosporine, azathioprine, mycophenolate mofetil within 4 weeks of the baseline visit and during the study
Where this trial is running
Los Angeles, California and 6 other locations
- Dermatology Research Associate — Los Angeles, California, United States (Recruiting)
- Dawes Fretzin Clinical Res LLC — Indianapolis, Indiana, United States (Recruiting)
- Revival Research Institute, LLC — Troy, Michigan, United States (Recruiting)
- Best Skin Research LLC — Camp Hill, Pennsylvania, United States (Recruiting)
- Goodlettsville Dermatology Research — Goodlettsville, Tennessee, United States (Recruiting)
- Arlington Research Center — Arlington, Texas, United States (Recruiting)
- Reveal Research Institute — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: CS45570 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.