Conditions: Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 355
Healthy volunteers: no

Brief summary:
This is a response-driven study of tildrakuzumab for the treatment of moderate to severe chronic plaque psoriasis. The primary study hypothesis is that one or more doses of tildrakizumab will be superior to placebo for the treatment of psoriasis.

Detailed description:
Each participant will be enrolled in the trial for approximately 72-76 weeks. Each participant will receive assigned treatment at Weeks 0 and 4 in Part I. At Week 16, the dosage of treatment the patient is assigned to may be adjusted based on the Psoriasis Area and Severity Index (PASI) 75 response (responder vs non-responder). Participants will receive study medication once every 12 weeks during Part 2 (Weeks 16 to 52); no participants will receive placebo in Part 2. Part 3 is an observational period and each subject will continue to be monitored on a monthly basis through Week 72. Subjects will not receive any study medication during Part 3.

Arms:
arm 1: Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 arm 2: Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 arm 3: Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 arm 4: Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 arm 5: Participants receive placebo, SC, at Weeks 0 and 4 arm 6: Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks arm 7: Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks arm 8: Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks arm 9: Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks arm 10: Participants are followed for up to 20 weeks after the last dose of study drug. arm 11: Participants are followed for up to 20 weeks after the last dose of study drug. arm 12: Participants are followed for up to 20 weeks after the last dose of study drug. arm 13: Participants are followed for up to 20 weeks after the last dose of study drug. arm 14: Participants are followed for up to 20 weeks after the last dose of study drug.

Interventions: intervention 1: tildrakizumab intervention 2: Placebo
Intervention descriptions: intervention 1: SC administration of tildrakizumab at assigned dose intervention 2: SC administration of Placebo

Protocol document: