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

Authors
Category Primary study
Registry of TrialsJapan Pharmaceutical Information Center
Year 2019
INTERVENTION: Intervention name : UCB4940 INN of the intervention : bimekizumab Dosage And administration of the intervention : During the 8‐week Treatment Period of DV0006, subjects will receive either bimekizumab 320mg every 8 weeks (Q8W) or bimekizumab 320mg every 4 weeks (Q4W), based on their assigned dosing at Baseline. The dose regimen will remain stable for the entire 8‐week Treatment Period of DV0006. In the DV0006 substudy, subjects will be assigned to 1 of the 2 self‐injection device presentations (randomized 1:1 to either bimekizumab‐SS‐1mL or bimekizumab‐AI‐1mL) and will self‐administer bimekizumab only at Baseline and at Week 8, regardless of their assigned dosing regimen. For subjects in the bimekizumab Q4W dosing arm, bimekizumab will be administered by study personnel at Week 4. Control intervention name : ‐ INN of the control intervention : ‐ Dosage And administration of the control intervention : ‐ CONDITION: Psoriasis PRIMARY OUTCOME: 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 OUTCOME: 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). 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.
Epistemonikos ID: 148847a2a569aac4bd026df9033702e3c32fd964
First added on: Aug 24, 2024