Moderate-to-Severe Chronic Plaque Psoriasis MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Tildrakizumab
Product Code: MK-3222 (SCH 900222)
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ti
Sponsors
Sun Pharma Global FZE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject (=18 years of age) with a clinical diagnosis of moderate-to-severe chronic plaque psoriasis (defined by =10% body surface area [BSA] involvement, at least "moderate" [=3] score on the PGA scale, and PASI score of =12 at Baseline [Visit 2]). - Subject must have a diagnosis of predominantly plaque psoriasis for =6 months (as determined by subject interview and confirmation of diagnosis through physical examination by investigator). - Subject must be considered a candidate for phototherapy or systemic therapy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44
Exclusion criteria
Exclusion criteria: - Subject has predominantly non-plaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new-onset guttate psoriasis. - Subject with current or history of severe psoriatic arthritis and is well-controlled on current therapy. - Women of childbearing potential who are pregnant, intend to become pregnant (within 6 months of completing the trial), or are lactating. - Subject who is expected to require topical therapy, phototherapy, or systemic therapy during the trial. - Subject with presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or severe infection (e.g. pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with IV antibiotics within 8 weeks prior to Screening. - Subject with any previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors, including p40, p19 and IL-17 antagonists. - Subject with evidence of active or untreated latent tuberculosis (TB) according to screening criteria specified in the protocol. Prophylactic treatment for latent TB as per local guidelines must be initiated at least 4 weeks prior to first administration of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Efficacy Objective: To assess the efficacy of tildrakizumab (SCH-900222/MK-3222) (hereafter referred to as MK-3222) compared to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of subjects with at least 75% improvement in the Psoriasis Area and Severity Index from baseline (PASI 75 response), and the proportion of subjects with a Physician’s Global Assessment (PGA) score of “clear” or “minimal”, with at least a 2 grade reduction from baseline, at Week 12. Primary Safety/Tolerability Objective: To assess the safety/tolerability of tildrakizumab (MK-3222) in subjects with moderate-to-severe chronic plaque psoriasis at Week 12. Extension Study: To assess long-term safety and tolerability of tildrakizumab (MK-3222) in subjects with moderate-to-severe chronic plaque psoriasis for a minimum of 4 years. ;Secondary Objective: To assess the efficacy of tildrakizumab (MK-3222) compared to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of subjects with at least 90% improvement in PASI from baseline (PASI 90 response) at Week 12.; Primary end point(s): Primary Efficacy Endpoints - Proportion of subjects with PASI 75 response at Week 12 - Proportion of subjects with a PGA score of "clear" or "minimal", with at least a 2 grade reduction from baseline, at Week 12. ;Timepoint(s) of evaluation of this end point: See section E.5.1 above. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: See section E.5.2 above.; Secondary end point(s): Key Secondary Efficacy Endpoint - Proportion of subjects with PASI 90 response at Week 12 - Proportion of subjects with PASI 100 response at Week 12 Other Secondary Efficacy Endpoints Part 1 (Weeks 0-12) - Change from baseline in DLQI from baseline at Week 12 - Proportion of subjects with a DLQI score of 0 or 1 at Week 12 - Proportion of subjects with ACR 20, ACR50 and ACR70 response at Week 12 (applicable only to subjects with concomitant psoriatic arthritis at baseline enrolled at Japanese Investigative sites) - Change from baseline in HAQ at Week 12 (applicable only to subjects with concomitant psoriatic arthritis at baseline enrolled at Japanese Investigative sites) - Change from baseline in PGAP (VAS for pain) at Week 12 (applicable only to subjects with concomitant psoriatic arthritis at baseline enrolled at Japanese Investigative sites) - Change and percent change from baseline in PASI score at Week 12 Parts 2 and 3 (Weeks 12 - 64) - Proportion of subjects with PASI 75 response at Weeks 28, 40, 52, and 64 - Proportion of subjects with PASI 90 response at Weeks 28, 40, 52, and 64 - Proportion of subjects with PASI 100 response at Weeks 28, 40, 52, and 64 - Proportion of subjects with PGA "clear" or "minimal", with at least a 2 grade reduction from baseline, at Weeks 28, 40, 52, and 64 - Change from baseline in DLQI response at Weeks 28, 40, 52 and 64 - Proportion of subjects with DLQI score of 0 or 1 at Weeks 28, 40, 52 | — |
Countries
Australia, Canada, Japan, United Kingdom, United States
Contacts
Public ContactShantanu Mehta
Sun Pharma Advanced Research Company Ltd.
Outcome results
None listed