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A Phase 3b, Open-label Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505558-16-00
Acronym
M-17923-33
Enrollment
218
Registered
2023-10-11
Start date
2023-10-24
Completion date
2025-06-16
Last updated
2025-04-01

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

Conditions

Atopic Dermatitis

Brief summary

Percentage of participants achieving EASI score ≤7 at Week 24

Detailed description

1. Percentage of participants achieving EASI score ≤7, EASI ≤5, and EASI ≤3 by visit, 2. Percentage of participants achieving EASI 75, and EASI 90 by visit, 3. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points by visit, 4. Percentage of participants achieving SCORAD 75 and SCORAD 90 by visit, 5. Percentage change from baseline in mTLSS (hands) from baseline by visit, 6. Percentage of participants with a Face IGA score of 0 or 1 and a reduction ≥2 points by visit, 7. Percentage of participants with Pruritus NRS ≥4 at baseline achieving ≥4-point improvement in Pruritus NRS from baseline by visit, 8. Percentage of participants achieving DLQI 0-1 by visit, 9. Percentage of participants with DLQI ≥4 at baseline achieving ≥4-point improvement in DLQI from baseline by visit, 10. Percentage of participants achieving cDLQI 0-1 by visit, 11. Percentage of participants with cDLQI ≥6 at baseline achieving ≥6-point improvement in cDLQI from baseline by visit, 12. Percentage of participants with a Sleep-Loss Scale of ≥2 points at baseline who achieve at least 2-point reduction by visit, 13. Percentage of participants with POEM ≥4 at baseline achieving ≥4-point improvement in POEM from baseline by visit, 14. Itch Controlled Days questionnaire score by visit, 15. TSQM-9 by visit

Interventions

DRUGLebrikizumab

Sponsors

Almirall S.A.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of participants achieving EASI score ≤7 at Week 24

Secondary

MeasureTime frame
1. Percentage of participants achieving EASI score ≤7, EASI ≤5, and EASI ≤3 by visit, 2. Percentage of participants achieving EASI 75, and EASI 90 by visit, 3. Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points by visit, 4. Percentage of participants achieving SCORAD 75 and SCORAD 90 by visit, 5. Percentage change from baseline in mTLSS (hands) from baseline by visit, 6. Percentage of participants with a Face IGA score of 0 or 1 and a reduction ≥2 points by visit, 7. Percentage of participants with Pruritus NRS ≥4 at baseline achieving ≥4-point improvement in Pruritus NRS from baseline by visit, 8. Percentage of participants achieving DLQI 0-1 by visit, 9. Percentage of participants with DLQI ≥4 at baseline achieving ≥4-point improvement in DLQI from baseline by visit, 10. Percentage of participants achieving cDLQI 0-1 by visit, 11. Percentage of participants with cDLQI ≥6 at baseline achieving ≥6-point improvement in cDLQI from baseline by visit, 12. Perc

Countries

Germany, Netherlands

Outcome results

None listed

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