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A MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGE OR THE AUTO-INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB SOLUTION BY SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

A MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFE AND EFFECTIVE USE OF THE PREFILLED SAFETY SYRINGE OR THE AUTO-INJECTOR FOR THE SUBCUTANEOUS SELF-INJECTION OF BIMEKIZUMAB SOLUTION BY SUBJECTS WITH MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224634
Enrollment
20
Registered
2019-04-11
Start date
2019-04-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Psoriasis

Interventions

investigational material(s) Generic name etc : UCB4940 INN of investigational material : bimekizumab Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for I

Sponsors

UCB Japan Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Subject fulfills all inclusion criteria for the PS0014 study. - Subject/legal representative is considered reliable and capable of adhering to the DV0006 protocol (eg, able to understand and complete questionnaires, able to use device presentations according to the IFU, and able to adhere to the visit schedule) according to the judgment of the Investigator. - Subject is willing to self-inject.

Exclusion criteria

Exclusion criteria: Subjects are not permitted to enroll in DV0006 if any of the PS0014 study exclusion criteria are met.

Design outcomes

Primary

MeasureTime frame
safety efficacy The primary outcome variable is the percentage of subjects able to self-administer safe and effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at Week 8.—

Secondary

MeasureTime frame
safety efficacy The secondary outcome variable is the percentage of subjects able to self-administer safe and effective injections using the bimekizumab-SS-1mL or the bimekizumab-AI-1mL at Baseline (the first self-injection visit, immediately after training in self-injection technique).—

Countries

Europe, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026