Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of tildrakizumab in the treatment of moderate to severe psoriasis of the nails. Subjects with a clinical diagnosis of chronic plaque psoriasis for at least 6 months and moderate to severe psoriasis of the nails at screening and baseline (mNAPSI score of ≥20, ViSENPsO of ≥3, and PASI≥12) as well as moderate to severe plaque psoriasis at screening and baseline (sPGA score of at least ≥3, and BSA involvement of ≥10%) and who are considered candidates for systemic therapy will be enrolled in the study. After a screening period of 28 days, all eligible subjects will be randomly allocated (in a 1:1 ratio after stratification according to previous use of TNF-alpha inhibitors [yes/no] and baseline body weight [90 kg]) on Day 1 to receive either tildrakizumab 100 mg or placebo by DocuSign Envelope ID: A3822F87-A3D9-49E8-B885-97066609D89E TILD-18-19 Amendment 2, 25 Sep 2021 Tildrakizumab Sun Pharma Global FZE Confidential Page 13 of 113 subcutaneous (SC) injection on Week 0 (Day 1), 4, and 16. Subjects should receive the first dose of study treatment within 24 hours of randomization. At Week 16, subjects who experience significant worsening of plaque psoriasis (defined as an increase in s-PGA by, at least, 2 from the baseline measurement) will be eligible for an early escape. Subjects selected for early escape by the Principal Investigator at Week 16 will have study medication discontinued, and will complete the End of Treatment visit assessment, followed by the observational safety follow-up period. Subjects entering early escape may be replaced so as to meet the planned evaluable sample size goal for the primary endpoint analysis. At Week 28, subjects initially randomized to placebo will be switched over to receive tildrakizumab 100 mg at Weeks 28, 32, and 44. Subjects initially randomized to tildrakizumab 100 mg will continue to receive tildrakizumab at Weeks 28, 40, and 52. In order to maintain the blind, subjects in both treatment arms will receive matching placebo injections at specified time points as described in the Schedule of Assessment (SoA). Subjects who experience significant worsening of plaque psoriasis at Week 28 (defined as an increase in s-PGA by, at least, 2 from the baseline measurement) will be discontinued from treatment. Subjects who do not fulfill this criterion at Week 28 will continue to receive tildrakizumab in Part 2 as described above. After Week 52 (or early termination of study treatment prior to Week 52), the study treatment should be stopped, and the subjects will enter the 20-week observational safety follow-up period following the last dose of study treatment. During the follow-up period, subjects should continue on study-approved concomitant medications only, however, may be placed on other appropriate therapies for safety concerns or significant worsening of psoriasis based on the judgment of the Investigator. The subjects will not receive study treatment during the follow-up period.
Qualified Participants Must:
• males and females, 18 years of age or older, who suffer from moderate to severe psoriasis/nail psoriasis
Qualified Participants May Receive:
• Study medication and study related office visits, at no cost.
• Qualified participants will received up to $900 for time and travel.
• No health insurance necessary