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LP0162-1335: A single (assessor) blinded, randomized, parallel-group, monotherapy trial to evaluate the pharmacokinetics and safety of tralokinumab in children (age 6 to <12 years) with moderate to-severe atopic dermatitis. - TRAPEDS 1 (TRAlokinumab PEDiatric trial no. 1).

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512791-36-00
Acronym
LP0162-1335
Enrollment
20
Registered
2024-09-03
Start date
2022-08-24
Completion date
Unknown
Last updated
2025-11-05

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

Conditions

Treatment of moderate-to-severe Atopic dermatitis

Brief summary

1. Ctrough at Week 16., 2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level

Detailed description

1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16)., 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16)., 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68)., 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68)., 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 7. Change in SCORAD from Week 0 to Week 68., 8. Change in POEM from Week 0 to Week 68., 9. Change in EASI from Week 0 to Week 68.

Interventions

Sponsors

Leo Pharma A/S
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
1. Ctrough at Week 16., 2. Cmax between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 3. AUC between Week 12-Week 14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level, 4. Tmax between Week 12-Week14 for Q2W (Week 12-Week 16 for Q4W).The endpoint will also be summarized by dosing interval within the low dose level

Secondary

MeasureTime frame
1. Number of treatment‑emergent adverse events in the initial treatment period (Week 0 to Week 16)., 2. Anti-drug antibodies (status) in the initial treatment period (Week 0 to Week 16)., 3. Number of treatment‑emergent adverse events in the open-label treatment period (Week 16 to Week 68)., 4. Anti-drug antibodies (status) in the open-label treatment period (Week 16 to Week 68)., 5. Number of treatment-emergent adverse events in the long term extension treatment period (Week 68 to end of treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 6. Anti-drug antibodies (status) in the long term extension treatment period (Week 68 to end-of-treatment visit (The end-of-treatment visit is held 2 weeks after end of treatment (defined as the date of the last IMP dose for each subject))., 7. Change in SCORAD from Week 0 to Week 68., 8. Change in POEM from Week 0 to Week 68., 9. Change in EASI from Week 0

Countries

Czechia, France, Netherlands, Spain

Outcome results

None listed

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