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tildrakizumab

Phase 2

Psoriasis | Monoclonal antibody | Immunology |Merck & Company, Inc.|Last Updated: Feb 5, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment355
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01225731A Study to Determine the Optimal Dose of Tildrakizumab (SCH 900222/MK-3222) for the Treatment of Moderate-to-severe Chronic Plaque Psoriasis (P05495) (MK-3222-003)PHASE2 COMPLETED 355Oct 25, 2010Oct 24, 2012Feb 5, 2019 -
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Study Endpoints
Primary Endpoints
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16
Week 16

The PASI score measures the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region producing a Lesion Score. The percentage of the area affected by disease is then estimated, ranging from 0 = no lesions to 6 = 90-100% of the region is covered providing an Area Score. Then, the Lesion Score and Area Score for each region are multiplied, producing 4 subtotals. The 4 region subtotals are multiplied by a standardized percentage of body surface area for that region (head = 0.1, trunk = 0.3, arms=0.2, and legs = 0.4); these four region calculations are added to provide the final PASI score, ranging from 0 = no disease to 72 = maximal disease). PASI 75 response was defined as \>=75% improvement in PASI score when compared to the baseline score.

Number of Participants Experiencing Adverse Events
Up to 72 weeks

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.

Number of Particpants Discontinuing Study Treatment Due to Adverse Events
Up to 52 weeks

An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. Participants may be discontinued from study drug due to adverse events, but remain on the study.

Secondary Endpoints
Percentage of Participants With a PASI 75 Response at Week 12
Week 12
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16
Week 16
Percentage of Participants With PASI 90 Response at Week 16
Week 16
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Tildrakizumab 5 mgEXPERIMENTALParticipants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Part 1: Tildrakizumab 25 mgEXPERIMENTALParticipants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Part 1: Tildrakizumab 100 mgEXPERIMENTALParticipants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Part 1: Tildrakizumab 200 mgEXPERIMENTALParticipants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Part 1: PlaceboPLACEBO_COMPARATORParticipants receive placebo, SC, at Weeks 0 and 4
Part 2: Tildrakizumab 5 mgEXPERIMENTALParticipants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
Part 2: Tildrakizumab 25 mgEXPERIMENTALParticipants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
Part 2: Tildrakizumab 100 mgEXPERIMENTALParticipants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
Part 2: Tildrakizumab 200 mgEXPERIMENTALParticipants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
Part 3: Tildrakizumab 5 mg Follow-upNO_INTERVENTIONParticipants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 25 mg Follow-upNO_INTERVENTIONParticipants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 100 mg Follow-upNO_INTERVENTIONParticipants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 200 mg Follow-upNO_INTERVENTIONParticipants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Placebo Follow-upNO_INTERVENTIONParticipants are followed for up to 20 weeks after the last dose of study drug.
Interventions
NameTypeDescription
tildrakizumabBIOLOGICALSC administration of tildrakizumab at assigned dose
PlaceboDRUGSC administration of Placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adult participants (≥18 years of age) with a diagnosis of moderate-to-severe chronic plaque psoriasis (defined by ≥10% body surface area \[BSA\] involvement, "moderate" or greater score on the Physician's Global Assessment \[PGA\] scale, and PASI score ≥12 at Baseline) * Parti...

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