A phase 3b, interventional, adaptive, clinical trial to evaluate the efficacy and safety of tralokinumab 300 mg every second week monotherapy compared with placebo in subjects with moderate-to-severe atopic hand eczema who are candidates for systemic therapy (ADHAND)

Status

Completed

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502653-34-01

Acronym

LP0162-2328

Enrollment

191

Registered

2024-01-30

Start date

2024-05-30

Completion date

2025-09-22

Last updated

2024-11-20

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

Conditions

Atopic dermatitis and moderate-to severe atopic hand eczema

Brief summary

IGA-AHEa score of 0 (clear) or 1 (almost clear) at Week 16.

Detailed description

Having a decrease in HECSIb of at least 75% (HECSI-75) from baseline to Week 16, Having a decrease in HECSI of at least 50% (HECSI-50) from baseline to Week 16., Having a decrease in HECSI of at least 90% (HECSI-90) from baseline to Week 16., Percentage change in HECSI score from baseline to Week 16, Having a ≥2-point reduction in IGA-AHE score from baseline to Week 16.

Interventions

DRUGTRALOKINUMAB

DRUGThe placebo presentation is a pre-filled syringe containing the same excipients in the same amounts as the IMP.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
IGA-AHEa score of 0 (clear) or 1 (almost clear) at Week 16.	—

Secondary

Measure	Time frame
Having a decrease in HECSIb of at least 75% (HECSI-75) from baseline to Week 16, Having a decrease in HECSI of at least 50% (HECSI-50) from baseline to Week 16., Having a decrease in HECSI of at least 90% (HECSI-90) from baseline to Week 16., Percentage change in HECSI score from baseline to Week 16, Having a ≥2-point reduction in IGA-AHE score from baseline to Week 16.	—

Countries

Belgium, Czechia, France, Germany, Netherlands, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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