Atopic Dermatitis
Conditions
Brief summary
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 (AD).
Interventions
DRUGAfimkibart
Afimkibart will be administered as SC injection.
DRUGPlacebo
Placebo will be administered as SC injection.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Achieve Eczema Area and Severity Index-75 (EASI-75) Response (>= 75% Improvement from Baseline) at Week 16 | Baseline and Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Achieve Investigator Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) with >= 2-Grade Improvement at Week 16 and Week 32 | At Week 16 and Week 32 |
| Percentage of Participants who Achieve EASI-75 Response at Week 32 | At Week 32 |
| Percentage of Participants who Achieve EASI-90 Response at Week 16 and Week 32 | At Week 16 and Week 32 |
| Percent Change from Baseline in EASI by Visit | Baseline up to end of study (approximately 1 year) |
| Percent Change from Baseline in Peak Pruritus Numerical Rating Scale (NRS) Score by Visit | Baseline up to end of study (approximately 1 year) |
| Change from Baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by Visit | Baseline, weeks 4, 10, 16, 22 and 32 |
| Percentage of EASI-75 Responders at Week 16 | At Week 16 |
| Percentage of Participants with Adverse Events | Baseline up to end of study (approximately 1 year) |
| Serum Concentration of Afimkibart at Specified Timepoints | Weeks 0, 2, 4, 6, 10, 14, 16, 18, 22, 26, 30, 32 and monthly at weeks 4, 8 and 12 after treatment discontinuation. |
Countries
Brazil, Canada, France, Germany, Italy, Poland, Spain, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed