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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515494-95-00
Acronym
CS45570
Enrollment
71
Registered
2025-04-22
Start date
2025-05-26
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to Severe Atopic Dermatitis (AD)

Brief summary

1. Proportion of participants who achieve eczema area and severity index-75 (EASI-75) response (≥ 75% improvement from baseline) Week 16

Detailed description

1. Proportion 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, 2. Proportion of participants who achieve EASI-75 response at Week 32, 3. Proportion of participants who achieve EASI-90 response at Week 16 and Week 32, 4. Percent change from baseline in EASI by visit, 5. Percent change from baseline in peak pruritus Numerical Rating Scale (NRS) score by visit, 6. Change from baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by visit, 7. Proportion of EASI-75 responders at week 16, 8. Incidence and severity of the following: – Adverse events – Serious adverse events – Adverse events leading to study treatment discontinuation – Adverse events of special interest, 9. Change from baseline in selected vital signs, 10. Change from baseline in selected clinical laboratory test results, 11. Serum concentration of RO7790121 at specified timepoints

Interventions

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Proportion of participants who achieve eczema area and severity index-75 (EASI-75) response (≥ 75% improvement from baseline) Week 16

Secondary

MeasureTime frame
1. Proportion 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, 2. Proportion of participants who achieve EASI-75 response at Week 32, 3. Proportion of participants who achieve EASI-90 response at Week 16 and Week 32, 4. Percent change from baseline in EASI by visit, 5. Percent change from baseline in peak pruritus Numerical Rating Scale (NRS) score by visit, 6. Change from baseline in Dermatology Quality of Life Index at Week 16, Week 32 and by visit, 7. Proportion of EASI-75 responders at week 16, 8. Incidence and severity of the following: – Adverse events – Serious adverse events – Adverse events leading to study treatment discontinuation – Adverse events of special interest, 9. Change from baseline in selected vital signs, 10. Change from baseline in selected clinical laboratory test results, 11. Serum concentration of RO7790121 at specified timepoints

Countries

France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026