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OptIMMize-1: A Randomized, Active-controlled, Efficacy Assessor-blinded Study to Evaluate Pharmacokinetics, Safety, and Efficacy of Risankizumab in Patients From 6 to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504156-10-00
Acronym
M19-977
Enrollment
72
Registered
2023-07-14
Start date
2021-08-13
Completion date
2024-10-01
Last updated
2024-11-25

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

Conditions

Plaque Psoriasis.

Brief summary

Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment

Detailed description

Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2., Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment, Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2., Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of a PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2, Change in Children's Dermatology Life Quality Index (CDLQI) from Week 0 to Week 16 of initial treatment in Part 2, Change in CDLQI from Week 0 to Week 16 of re-treatment phase of Part 2, Change in Family Dermatology Life Quality Index (FDLQI) from Week 0 to Week 16 of initial treatment in Part 2, Change in FDLQI from Week 0 to Week 16 of re-treatment phase of Part 2, Change in Itch Numerical Rating Scale (Itch NRS) from Week 0 to Week 16 of initial treatment in Part 2, Change in Itch NRS from Week 0 to Week 16 of re-treatment phase in Part 2, Achievement of ≥ 4-point improvement from baseline in the Itch Numerical Rating Scale (in patients with Baseline score ≥ 4) at Week 16 of initial treatment in Part 2

Interventions

DRUGRisankizumab

Sponsors

Abbvie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Co-primary Endpoints: - Achievement of PASI 75 (defined as at least 75% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear (0 or 1) at Week 16 of initial treatment

Secondary

MeasureTime frame
Ranked Secondary Endpoints: Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 16 of initial treatment., Achievement of sPGA clear or almost clear at (0 or 1) at Week 0 and Week 16 of the retreatment phase in Part 2., Non-ranked Secondary Efficacy Endpoints: Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 16 of initial treatment, Achievement of PASI 50 (defined as at least 50% improvement from baseline in PASI) at Week 0 and Week 16 of the re-treatment phase in Part 2., Achievement of PASI 90 (defined as at least 90% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of PASI 100 (defined as 100% improvement from baseline in PASI) at Week 0 and Week 16 of the retreatment phase in Part 2., Achievement of a PASI 75 (defined as at least 75% impr

Countries

Germany, Poland, Spain

Outcome results

None listed

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