A Study to Determine the Optimal Dose of Tildrakizumab (S... | NCT01225731 | Trialant
NCT01225731
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 5, 2019Actual
Enrollment
355Actual
Phase
Phase 2
Conditions
Psoriasis
Interventions
tildrakizumab
Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01225731
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
P05495
Secondary IDs
ID
Type
Description
Link
2009-017272-24
EudraCT Number
MK-3222-003
Other Identifier
Merck Research Laboratories
Brief Title
A 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)
Official Title
Randomized, Double-Blinded, Placebo-Controlled, Parallel-Design, Dose-Range Finding Study of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Study P05495)
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jan 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 25, 2010Actual
Primary Completion Date
Nov 4, 2011Actual
Completion Date
Oct 24, 2012Actual
First Submitted Date
Oct 7, 2010
First Submission Date that Met QC Criteria
Oct 20, 2010
First Posted Date
Oct 21, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 18, 2015
Results First Submitted that Met QC Criteria
Mar 18, 2015
Results First Posted Date
Mar 30, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 18, 2019
Last Update Posted Date
Feb 5, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
355Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Tildrakizumab 5 mg
Experimental
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Biological: tildrakizumab
Part 1: Tildrakizumab 25 mg
Experimental
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Biological: tildrakizumab
Part 1: Tildrakizumab 100 mg
Experimental
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Biological: tildrakizumab
Part 1: Tildrakizumab 200 mg
Experimental
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Biological: tildrakizumab
Part 1: Placebo
Placebo Comparator
Participants receive placebo, SC, at Weeks 0 and 4
Drug: Placebo
Part 2: Tildrakizumab 5 mg
Experimental
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
Interventions
Name
Type
Description
Arm Group Labels
Other Names
tildrakizumab
Biological
SC administration of tildrakizumab at assigned dose
Part 1: Tildrakizumab 100 mg
Part 1: Tildrakizumab 200 mg
Part 1: Tildrakizumab 25 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at 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.
Week 16
Number of Participants Experiencing Adverse Events
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.
Up to 72 weeks
Number of Particpants Discontinuing Study Treatment Due to Adverse Events
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.
Up to 52 weeks
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a PASI 75 Response at Week 12
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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)
Participants must have a diagnosis of predominantly plaque psoriasis for ≥6 months (as determined by interview and confirmation of diagnosis through physical examination by investigator) and be considered candidates for phototherapy or systemic therapy. Participants with psoriatic arthritis may be included in the study
Exclusion Criteria:
Nonplaque forms of psoriasis specifically erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
Participants who will require oral or injectable corticosteroids during the trial
Presence of any infection requiring treatment with systemic antibiotics within 2 weeks prior to Screening, or serious infection (eg, pneumonia, cellulitis, bone or joint infections) requiring hospitalization or treatment with intravenous antibiotics within 8 weeks prior to Screening
Participants 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 treatment with study medication)
Previous exposure to any agents targeting interleukin-12 (IL-12) and/or Interleukin-23 (IL-23)
Participants with prior exposure to two or more tumor necrosis factor (TNF) antagonists with discontinuation due to lack of efficacy.
Papp K, Thaci D, Reich K, Riedl E, Langley RG, Krueger JG, Gottlieb AB, Nakagawa H, Bowman EP, Mehta A, Li Q, Zhou Y, Shames R. Tildrakizumab (MK-3222), an anti-interleukin-23p19 monoclonal antibody, improves psoriasis in a phase IIb randomized placebo-controlled trial. Br J Dermatol. 2015 Oct;173(4):930-9. doi: 10.1111/bjd.13932. Epub 2015 Oct 15.
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
FG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
Canada
France
Germany
Norway
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Biological: tildrakizumab
Part 2: Tildrakizumab 25 mg
Experimental
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
Biological: tildrakizumab
Part 2: Tildrakizumab 100 mg
Experimental
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
Biological: tildrakizumab
Part 2: Tildrakizumab 200 mg
Experimental
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
Biological: tildrakizumab
Part 3: Tildrakizumab 5 mg Follow-up
No Intervention
Participants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 25 mg Follow-up
No Intervention
Participants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 100 mg Follow-up
No Intervention
Participants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Tildrakizumab 200 mg Follow-up
No Intervention
Participants are followed for up to 20 weeks after the last dose of study drug.
Part 3: Placebo Follow-up
No Intervention
Participants are followed for up to 20 weeks after the last dose of study drug.
Part 1: Tildrakizumab 5 mg
Part 2: Tildrakizumab 100 mg
Part 2: Tildrakizumab 200 mg
Part 2: Tildrakizumab 25 mg
Part 2: Tildrakizumab 5 mg
SCH 900222
MK-3222
Placebo
Drug
SC administration of Placebo
Part 1: Placebo
Week 12
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16
The PGA is used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
Week 16
Percentage of Participants With PASI 90 Response at 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 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.
Week 16
Percentage of Participants With PASI 100 Response at 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 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.
Week 16
PASI 75 Response Rate by Time
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 at Week 2, 4, 6, 8, 12, or 16.
Up to 16 Weeks
Mean Change From Baseline in PASI Score at Weeks 12 and 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).
Baseline and Weeks 12 and 16
Percentage of Participants With PASI 50 Response at 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 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.
Week 16
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Week 16
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Week 16
Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
Week 16
Derived
Kerbusch T, Li H, Wada R, Jauslin PM, Wenning L. Exposure-response characterisation of tildrakizumab in chronic plaque psoriasis: Pooled analysis of 3 randomised controlled trials. Br J Clin Pharmacol. 2020 Sep;86(9):1795-1806. doi: 10.1111/bcp.14280. Epub 2020 Mar 25.
Jauslin P, Kulkarni P, Li H, Vatakuti S, Hussain A, Wenning L, Kerbusch T. Population-Pharmacokinetic Modeling of Tildrakizumab (MK-3222), an Anti-Interleukin-23-p19 Monoclonal Antibody, in Healthy Volunteers and Subjects with Psoriasis. Clin Pharmacokinet. 2019 Aug;58(8):1059-1068. doi: 10.1007/s40262-019-00743-7.
FG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
FG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
FG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
FG005
Part 2: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
FG006
Part 2: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
FG007
Part 2: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
FG008
Part 2: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
FG009
Part 3: Tildrakizumab 5 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
FG010
Part 3: Tildrakizumab 25 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
FG011
Part 3: Tildrakizumab 100 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
FG012
Part 3: Tildrakizumab 200 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
FG00042 subjects
FG00192 subjects
FG00289 subjects
FG00386 subjects
FG00446 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG00040 subjects
FG00187 subjects
FG00288 subjects
FG00384 subjects
FG00440 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0002 subjects
FG0015 subjects
FG0021 subjects
FG0032 subjects
FG0046 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Type
Comment
Reasons
Did not meet eligibility criteria
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Adverse Event
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants could progress into Part 2
FG0010 subjectsParticipants could progress into Part 2
FG0020 subjectsParticipants could progress into Part 2
FG0030 subjectsParticipants could progress into Part 2
FG0040 subjectsParticipants could progress into Part 2; no placebo was given in Part 2
FG00513 subjectsParticipants were reassigned based on PASI score at Week 16
FG00694 subjectsParticipants were reassigned based on PASI score at Week 16
FG007153 subjectsParticipants were reassigned based on PASI score at Week 16
FG00879 subjectsParticipants were reassigned based on PASI score at Week 16
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjectsParticipants could enter the follow-up period
FG0060 subjectsParticipants could enter the follow-up period
FG0070 subjectsParticipants could enter the follow-up period
FG0080 subjectsParticipants could enter the follow-up period
FG00910 subjectsNot all participants entered follow-up
FG01086 subjectsNot all participants entered follow-up
FG011126 subjectsNot all participants entered follow-up
FG01267 subjectsNot all participants entered follow-up
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
BG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
BG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
BG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
BG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00042
BG00192
BG00289
BG00386
BG00446
BG005355
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00043.2± 12.9
BG00146.3± 13.7
BG00245.5± 12.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00011
BG00132
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at 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.
The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG003
Title
Denominators
Categories
Title
Measurements
OG00033.33
OG00164.44
OG00266.29
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
0.001
% Difference in Response Rate
28.89
2-Sided
95
13.41
44.36
Superiority or Other
OG001
OG004
Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With a PASI 75 Response at Week 12
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.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Secondary
Percentage of Participants With Physician's Global Assessment (PGA) of "Cleared" or "Minimal" at Week 16
The PGA is used to determine the overall severity of a subject's psoriasis lesions at a given time point. Overall lesions will be graded for induration, erythema, and scaling on a scale from 0 to 5. The sum of the 3 scales will be divided by 3 to obtain the PGA score. PGA is assessed as: 0= Cleared, except for residual discoloration. 1= Minimal, majority of lesions have individual scores that average . 2 =Mild, majority of lesions have individual scores that average 2. 3= Modreate, majority of lesions have individual scores that average 3. 4= Marked, majority of lesions have individual scores that average 4. 5= Severe, majority of lesions have individual scores that average 5.
The Full Analysis Set (FAS), all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PGA value was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Secondary
Percentage of Participants With PASI 90 Response at 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 90 response was defined as >=90 % improvement in PASI score when compared to the baseline score.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Secondary
Percentage of Participants With PASI 100 Response at 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 100 response was defined as 100 % improvement in PASI score when compared to the baseline score.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data fior this endpoint
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Secondary
PASI 75 Response Rate by Time
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 at Week 2, 4, 6, 8, 12, or 16.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. and data for the specific Week.
Posted
Number
Percentage of participants
Up to 16 Weeks
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Secondary
Mean Change From Baseline in PASI Score at Weeks 12 and 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).
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for Week 12 and Week 16.
Posted
Mean
95% Confidence Interval
Score on a scale
Baseline and Weeks 12 and 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Secondary
Percentage of Participants With PASI 50 Response at 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 50 response was defined as >=50 % improvement in PASI score when compared to the baseline score.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement. The last non-missing post-baseline PASI score was carried forward (LOCF) unless the participant discontinued drug due to lack of efficacy, loss of response, or use of prohibited medications.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Secondary
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.
Posted
Mean
95% Confidence Interval
Score on a scale
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Secondary
Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and data for this endpoint, excluding all participants on the placebo arm.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Secondary
Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16
The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses range from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life.
The FAS, all randomized participants who received >=1 dose of study drug and had a baseline and >=1 post-treatment efficacy measurement, and had data for this endpoint.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Primary
Number of Participants Experiencing Adverse Events
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.
All participants receiving at least one dose of study drug.
Posted
Number
Participants
Up to 72 weeks
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Primary
Number of Particpants Discontinuing Study Treatment Due to Adverse Events
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.
All particpants receiving at least one dose of study drug during the treatment period.
Posted
Number
Participants
Up to 52 weeks
ID
Title
Description
OG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
OG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Time Frame
Up to 72 weeks
Description
All participants who received at least one dose of tildrakizumab or placebo.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
0
42
20
42
EG001
Part 1: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
1
91
35
91
EG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
1
89
33
89
EG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
2
86
30
86
EG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
0
45
21
45
EG005
Part 2: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
0
13
7
13
EG006
Part 2: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
5
94
38
94
EG007
Part 2: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
6
153
64
153
EG008
Part 2: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
3
79
32
79
EG009
Part 3: Tildrakizumab 5 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
0
12
3
12
EG010
Part 3: Tildrakizumab 25 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
1
87
14
87
EG011
Part 3: Tildrakizumab 100 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
2
137
29
137
EG012
Part 3: Tildrakizumab 200 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug.
2
75
17
75
EG013
Placebo Follow-up
Participants who received placebo in Part 1 and did not receive additional therapy.
1
2
1
2
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Death
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0021 events1 affected89 at risk
EG0030 events0 affected86 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected13 at risk
EG0060 events0 affected94 at risk
EG0070 events0 affected153 at risk
EG0080 events0 affected79 at risk
EG0090 events0 affected12 at risk
EG0100 events0 affected87 at risk
EG0110 events0 affected137 at risk
EG0120 events0 affected75 at risk
EG0130 events0 affected2 at risk
Arthritis bacterial
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Tendonn rupture
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Hernia
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Thrombotic cerebral infarction
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Odontogenic cyst
Congenital, familial and genetic disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG0030 events0 affected86 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected13 at risk
EG0061 events1 affected94 at risk
EG0070 events0 affected153 at risk
EG0080 events0 affected79 at risk
EG0090 events0 affected12 at risk
EG0100 events0 affected87 at risk
EG0110 events0 affected137 at risk
EG0120 events0 affected75 at risk
EG0130 events0 affected2 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0015 events5 affected91 at risk
EG0027 events6 affected89 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0021 events1 affected89 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Pyrexia
General disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected91 at risk
EG0024 events3 affected89 at risk
EG003
Acute tonsilitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Bronchiitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0013 events3 affected91 at risk
EG0021 events1 affected89 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Ear infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Folliculitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected91 at risk
EG0021 events1 affected89 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0010 events0 affected91 at risk
EG0023 events3 affected89 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0009 events7 affected42 at risk
EG00114 events12 affected91 at risk
EG00215 events13 affected89 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0011 events1 affected91 at risk
EG0022 events2 affected89 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA 15.1
Systematic Assessment
EG0003 events2 affected42 at risk
EG0010 events0 affected91 at risk
EG0023 events3 affected89 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0012 events2 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Blood pressure systolic increased
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Hypercholesterolaemia
Investigations
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0014 events4 affected91 at risk
EG0024 events3 affected89 at risk
EG003
Headache
Nervous system disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0018 events5 affected91 at risk
EG0028 events6 affected89 at risk
EG003
Sleep disorder
Psychiatric disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0012 events2 affected91 at risk
EG0022 events2 affected89 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 15.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 15.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0015 events4 affected91 at risk
EG0020 events0 affected89 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The Investigator agrees not to publish or publicly present any interim results of the trial without the prior written consent of the Sponsor. The investigator further agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication in any media that report any results of the trial. The Sponsor shall have the right to review and comment on the data analysis and presentation.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme
1-800-672-6372
ClinicalTrialsDisclosure@merck.com
ID
Term
D011565
Psoriasis
Ancestor Terms
ID
Term
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000598434
tildrakizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
4 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG00510 subjects
FG00686 subjects
FG007128 subjects
FG00868 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0053 subjects
FG0068 subjects
FG00725 subjects
FG00811 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0064 subjects
FG0074 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG00712 subjects
FG0083 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0073 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0063 subjects
FG0074 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00910 subjects
FG01080 subjects
FG011116 subjects
FG01260 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0106 subjects
FG01110 subjects
FG0127 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0111 subjects
FG0120 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0112 subjects
FG0121 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0122 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0104 subjects
FG0116 subjects
FG0124 subjects
43.2
± 12.6
BG00445.9± 11.7
BG00544.9± 12.9
13
BG00321
BG0048
BG00585
Male
BG00031
BG00160
BG00276
BG00365
BG00438
BG005270
86
OG00445
74.42
OG0044.44
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
60.00
2-Sided
95
48.42
71.58
Superiority or Other
OG002
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
61.85
2-Sided
95
50.33
73.37
Superiority or Other
OG003
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
69.97
2-Sided
95
58.96
80.99
Superiority or Other
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG00386
OG00445
Title
Denominators
Categories
Title
Measurements
OG00023.81
OG00158.89
OG00260.67
OG00372.09
OG0044.44
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
0.009
% Difference in Response Rate
19.37
2-Sided
95
5.15
33.58
Superiority or Other
OG001
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
54.44
2-Sided
95
42.63
66.26
Superiority or Other
OG002
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
56.23
2-Sided
95
44.43
68.03
Superiority or Other
OG003
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
67.65
2-Sided
95
56.42
78.88
Superiority or Other
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG00386
OG00445
Title
Denominators
Categories
Title
Measurements
OG00033.33
OG00157.78
OG00261.80
OG00374.42
OG0042.22
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
31.11
2-Sided
95
16.22
46.0
Superiority or Other
OG001
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
55.56
2-Sided
95
44.48
66.63
Superiority or Other
OG002
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
59.58
2-Sided
95
48.60
70.55
Superiority or Other
OG003
OG004
Cochran-Mantel-Haenszel
Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
<0.001
% Difference in Response Rate
72.20
2-Sided
95
62.02
82.37
Superiority or Other
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00040
OG00187
OG00288
OG00384
OG00441
Title
Denominators
Categories
Title
Measurements
OG00012.50
OG00125.29
OG00238.64
OG00352.38
OG0042.44
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00040
OG00187
OG00288
OG00384
OG00441
Title
Denominators
Categories
Title
Measurements
OG0005.0
OG0019.20
OG00214.77
OG00316.67
OG0040.00
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG00386
OG00445
Title
Denominators
Categories
Week 2 (n=42, 89, 89, 85, 45)
Title
Measurements
OG0000.00
OG0011.12
OG0021.12
OG0030.00
OG0040.00
Week 4 (n=42, 89, 89, 85, 45)
Title
Measurements
OG0000.00
OG00111.24
OG00211.24
OG003
Week 6 (n=40, 86, 88, 84,44)
Title
Measurements
OG00012.50
OG00120.93
OG00225.00
OG003
Week 8 (n=40, 88, 87, 83, 43)
Title
Measurements
OG00012.50
OG00135.23
OG00247.13
OG003
Week 12 (n=40, 87, 88, 83, 42)
Title
Measurements
OG00025.00
OG00159.77
OG00261.36
OG003
Week 16 (n=40, 87, 88, 84, 41)
Title
Measurements
OG00035.00
OG00165.52
OG00267.05
OG003
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG00386
OG00445
Title
Denominators
Categories
Week 12
Title
Measurements
OG000-10.2(-12.5 to -7.9)
OG001-14.4(-16.0 to -12.9)
OG002-14.1(-15.7 to -12.5)
OG003-14.9(-16.5 to -13.3)
OG004-2.2(-4.4 to 0.00)
Week 16
Title
Measurements
OG000-10.0(-12.3 to -7.6)
OG001-14.6(-16.2 to -13.0)
OG002-14.9(-16.5 to -13.3)
OG003
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
OG002
Part 1: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00042
OG00190
OG00289
OG00386
OG00445
Title
Denominators
Categories
Title
Measurements
OG00057.14
OG00182.22
OG00282.02
OG00391.86
OG0048.89
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00040
OG00187
OG00288
OG00383
OG00442
Title
Denominators
Categories
Title
Measurements
OG000-4.9(-7.0 to -2.8)
OG001-9.2(-10.6 to -7.7)
OG002-8.5(-9.9 to -7.1)
OG003-8.8(-10.3 to -7.4)
OG0041.0(-1.1 to 3.0)
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00040
OG00187
OG00288
OG00383
Title
Denominators
Categories
Title
Measurements
OG00032.5
OG00157.47
OG00252.27
OG00357.83
OG003
Part 1: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
Units
Counts
Participants
OG00040
OG00187
OG00288
OG00383
OG00442
Title
Denominators
Categories
Title
Measurements
OG00052.50
OG00170.11
OG00264.77
OG00373.49
OG00419.05
Participants receive placebo, SC, at Weeks 0 and 4
OG005
Part 2: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
OG006
Part 2: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
OG007
Part 2: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
OG008
Part 2: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
OG009
Part 3: Tildrakizumab 5 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug
OG010
Part 3: Tildrakizumab 25 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug
OG011
Part 3: Tildrakizumab 100 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug
OG012
Part 3: Tildrakizumab 200 mg Follow-up
Participants are followed for up to 20 weeks after the last dose of study drug
Units
Counts
Participants
OG00042
OG00191
OG00289
OG00386
OG00445
OG00513
OG00694
OG007153
OG00879
OG00910
OG01086
OG011126
OG01267
Title
Denominators
Categories
Title
Measurements
OG00030
OG00156
OG00258
OG00354
OG00431
OG0057
OG00660
OG007105
OG00852
OG0093
OG01032
OG01153
OG01228
OG004
Part 1: Placebo
Participants receive placebo, SC, at Weeks 0 and 4
OG005
Part 2: Tildrakizumab 5 mg
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
OG006
Part 2: Tildrakizumab 25 mg
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
OG007
Part 2: Tildrakizumab 100 mg
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
OG008
Part 2: Tildrakizumab 200 mg
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks