A Study to Evaluate the Efficacy and Safety of Subcutaneo... | NCT01722331 | Trialant
NCT01722331
Sponsor
Sun Pharmaceutical Industries Limited
Status
Completed
Last Update Posted
Mar 23, 2022Actual
Enrollment
772Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
Tildrakizumab 200 mg
Tildrakizumab 100 mg
Matching Placebo
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01722331
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3222-010
Secondary IDs
ID
Type
Description
Link
2012-002255-42
EudraCT Number
P07770
Other Identifier
Merck Protocol Number
132284
Registry Identifier
JAPIC-CTI
Brief Title
A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
Official Title
A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Acronym
reSURFACE 1
Organization
Sun Pharmaceutical Industries LimitedINDUSTRY
Status Module
Record Verification Date
Feb 2022
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
Dec 6, 2012Actual
Primary Completion Date
Oct 28, 2015Actual
Completion Date
Nov 10, 2021Actual
First Submitted Date
Nov 2, 2012
First Submission Date that Met QC Criteria
Nov 2, 2012
First Posted Date
Nov 6, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 28, 2018
Results First Submitted that Met QC Criteria
May 14, 2018
Results First Posted Date
Jun 13, 2018Actual
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
Feb 23, 2022
Last Update Posted Date
Mar 23, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Sun Pharmaceutical Industries LimitedINDUSTRY
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 study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.
Detailed Description
Participants are initially randomized to receive tildrakizumab 200 or 100 mg once weekly at Weeks 0, 4, and every 12 weeks thereafter; or placebo at Weeks 0 and 4.
At Week 12, participants initially randomized to placebo will be re-randomized to receive either tildrakizumab 200 or 100 mg at Weeks 12 and 16.
At Week 28, all participants enrolled will be assessed for their improvement in PASI score from baseline.
RESPONDERS: Participants initially randomized to tildrakizumab who achieve at least a 75% improvement from baseline PASI will be re-randomized to either continue on their initial treatment or to receive placebo at Week 28.
Participants who are re-randomized to continue on their initial treatment will continue tildrakizumab 200 or 100 mg every 12 weeks through Week 64.
Participants who are re-randomized to placebo will receive placebo every 4 weeks until relapse (reduction in maximum PASI response by 50%). If relapse occurs, the tildrakizumab dose that the participants was originally randomized to at baseline will be re-initiated (tildrakizumab 200 or 100 mg). Participants will be dosed tildrakizumab at the visit when the relapse occurs, and subsequent dosing of tildrakizumab will be given 4 weeks after treatment re-initiation, and every 12 weeks thereafter through Week 64.
PARTIAL RESPONDERS: Participants initially randomized to tildrakizumab who achieved a PASI response of ≥50% but <75% improvement from baseline will be assigned a treatment regimen as described below, with their first dose started at Week 28.
Participants initially randomized to tildrakizumab 200 mg will remain on tildrakizumab 200 mg every 12 weeks.
Participants initially randomized to tildrakizumab 100 mg will be re-randomized to either remain on tildrakizumab 100 mg every 12 weeks or to receive tildrakizumab 200 mg every 12 weeks.
Participants initially randomized to placebo who achieved ≥50% improvement from baseline in PASI will receive tildrakizumab (200 or 100 mg) according to their re-randomized treatment assignment at Week 12 and continue on this treatment every 12 weeks through Week 64.
NON-RESPONDERS: Participants who did not achieve at least 50% improvement from baseline PASI at Week 28 will be discontinued from the study.
EXTENSION: Participants will receive tildrakizumab 200 mg or 100 mg every 12 weeks through Extension Week 192, depending on the treatment received at the time of completion of the base study.
Conditions Module
Conditions
Plaque 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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
772Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Tildrakizumab 200 mg
Experimental
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
Drug: Tildrakizumab 200 mg
Drug: Matching Placebo
Tildrakizumab 100 mg
Experimental
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Drug: Tildrakizumab 100 mg
Drug: Matching Placebo
Placebo
Placebo Comparator
Matching placebo administered SC once a week at Weeks 0 and 4.
Drug: Tildrakizumab 200 mg
Drug: Tildrakizumab 100 mg
Drug: Matching Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Tildrakizumab 200 mg
Drug
Two tildrakizumab 100 mg/mL pre-filled syringes (PFS)
Placebo
Tildrakizumab 200 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Week 12 (or end of trial if prior to Week 12)
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, 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 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, 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.
Baseline and Week 12 (or end of trial if prior to Week 12)
Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Up to 12 weeks
Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With PASI-90 Response At Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to study enrollment
A candidate for phototherapy or systemic therapy
For the extension study: must have completed Part 3 of the base study
For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study
For the extension study: must have received active tildrakizumab (MK-3222) treatment within 12 weeks prior to the end of Part 3 of the base study
Premenopausal female participants must agree to abstain from heterosexual activity or use a medically accepted method of contraception or use appropriate effective contraception as per local regulations or guidelines
If enrolled at a Japanese site, participants with psoriatic arthritis using non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4 weeks prior to the first dose of study drug and must not be expected to require an increase in dose over the course of the study
Exclusion Criteria:
Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
Current or history of severe psoriatic arthritis and is well-controlled on current treatment
Women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
Expected to require topical treatment, phototherapy, or systemic treatment during the trial
Presence of any infection
History of recurrent infection requiring treatment with systemic antibiotics within 2 weeks of screening
Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors including P40, p19, and IL-17 antagonists
Evidence of active or untreated latent tuberculosis (TB)
Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)
At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA
For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study
At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the screening visit.
Reich K, Papp KA, Blauvelt A, Tyring SK, Sinclair R, Thaci D, Nograles K, Mehta A, Cichanowitz N, Li Q, Liu K, La Rosa C, Green S, Kimball AB. Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials. Lancet. 2017 Jul 15;390(10091):276-288. doi: 10.1016/S0140-6736(17)31279-5. Epub 2017 Jun 6.
The tables below present the Participant Flow for the Base Study only (Weeks 0 to 64: Part 1 for 12 weeks, Part 2 for 16 weeks, and Part 3 for 36 weeks).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Tildrakizumab 200 mg (Parts 1, 2 & 3)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
FG001
Tildrakizumab 100 mg (Parts 1, 2 & 3)
Periods
Title
Milestones
Reasons Not Completed
Part 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
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
Australia
Canada
Japan
United Kingdom
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
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
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
MK-3222, SCH 900222
Tildrakizumab 100 mg
Drug
Tildrakizumab 100 mg/mL PFS
Placebo
Tildrakizumab 100 mg
MK-3222, SCH 900222
Matching Placebo
Drug
Matching placebo to tildrakizumab PFS
Placebo
Tildrakizumab 100 mg
Tildrakizumab 200 mg
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Up to 12 weeks
Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)
A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.
Up to 12 weeks
Week 12 (or end of trial if prior to Week 12)
Percentage of Participants With PASI-100 Response at Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Week 12 (or end of trial if prior to Week 12)
Baseline Dermatology Life Quality Index (DLQI) Score
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Baseline
Change From Baseline in the Participant DLQI Score at Week 12
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.
Baseline and Week 12 (or end of trial if prior to Week 12)
Percentage of Participants With DLQI Score of 0 or 1 at Week 12
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Week 12 (or end of trial if prior to Week 12)
Derived
Bagel J, Gogineni R, Shaikh A, Lebwohl MG. Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2. Dermatol Ther (Heidelb). 2026 Apr;16(4):2153-2167. doi: 10.1007/s13555-026-01708-y. Epub 2026 Mar 16.
Armstrong AW, Blauvelt A, Lebwohl M, Asahina A, Gogineni R, Griffiths CEM. Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis. Br J Dermatol. 2025 Aug 18;193(3):442-450. doi: 10.1093/bjd/ljaf171.
Thaci D, Gerdes S, Du Jardin KG, Perrot JL, Puig L. Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies. Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13.
Igarashi A, Nakagawa H, Morita A, Okubo Y, Sano S, Imafuku S, Tada Y, Honma M, Mendelsohn AM, Kawamura M, Ohtsuki M. Efficacy and safety of tildrakizumab in Japanese patients with moderate to severe plaque psoriasis: Results from a 64-week phase 3 study (reSURFACE 1). J Dermatol. 2021 Jun;48(6):853-863. doi: 10.1111/1346-8138.15789. Epub 2021 Feb 25.
Reich K, Warren RB, Iversen L, Puig L, Pau-Charles I, Igarashi A, Ohtsuki M, Falques M, Harmut M, Rozzo S, Lebwohl MG, Cantrell W, Blauvelt A, Thaci D. Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks. Br J Dermatol. 2020 Mar;182(3):605-617. doi: 10.1111/bjd.18232. Epub 2019 Jul 18.
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.
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1), Week 16 (Part 2), and Weeks 28, 40, 52 and 64 (Part 3).
FG002
Tildrakizumab 100 mg (Parts 1 & 2)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2).
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 (Part 1) and Week 16 (Part 2). Tildrakizumab 200 mg administered SC once a week at Weeks 28, 40, 52, and 64 (Part 3).
FG004
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1).
Matching placebo administered SC once a week at Weeks 0 and 4 (Part 1). Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
Matching placebo administered SC once a week at Weeks 0 and 4. Tildrakizumab 200 mg administered SC once a week at Week 16 (Part 2) and Weeks 28, 40, 52 and 64 (Part 3).
FG000308 subjects
FG001249 subjects
FG00241 subjects
FG00319 subjects
FG0049 subjects
FG00572 subjects
FG00674 subjects
COMPLETED
FG000298 subjects
FG001249 subjects
FG00232 subjects
FG00319 subjects
FG0040 subjects
FG00572 subjects
FG00674 subjects
NOT COMPLETED
FG00010 subjects
FG0010 subjects
FG0029 subjects
FG0030 subjects
FG0049 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Pregnancy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG004
Part 2
Type
Comment
Milestone Data
STARTED
FG000298 subjects
FG001249 subjects
FG00231 subjects1 participant who completed Part 1 did not enter Part 2
FG00319 subjects
FG0040 subjects
FG00572 subjects
FG00674 subjects
COMPLETED
FG000279 subjects
FG001249 subjects
FG0020 subjects
FG00319 subjects
FG004
NOT COMPLETED
FG00019 subjects
FG0010 subjects
FG00231 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG003
Part 3
Type
Comment
Milestone Data
STARTED
FG000279 subjects
FG001249 subjects
FG0020 subjects
FG00319 subjects
FG0040 subjects
FG00562 subjects
FG00667 subjects
COMPLETED
FG000264 subjects
FG001232 subjects
FG0020 subjects
FG00318 subjects
FG004
NOT COMPLETED
FG00015 subjects
FG00117 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0012 subjects
FG0020 subjects
FG003
Overall Number of Baseline Participants includes randomized participants according to assigned treatment for Part 1 of the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
BG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
BG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000308
BG001309
BG002155
BG003772
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
ParticipantsBG000308
ParticipantsBG001309
ParticipantsBG002155
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000308
ParticipantsBG001309
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000308
ParticipantsBG001309
ParticipantsBG002
Physician's Global Assessment (PGA) score
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, 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; 2 =Mild; 3= Moderate; 4= Marked; 5= Severe. Round average to the nearest whole number.
Analysis population includes participants with baseline PGA data.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000308
ParticipantsBG001
Body weight
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000308
ParticipantsBG001309
ParticipantsBG002
Prior exposure to biologics therapy for psoriasis
The following therapies constitute biologics therapy for psoriasis: efalizumab, alefacept, infliximab, adalimumab, ustekinumab, and etanercept.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000308
ParticipantsBG001309
ParticipantsBG002
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 Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study)
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Posted
Number
Percentage of Participants
Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG00062.3
OG00163.8
OG0025.8
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
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
56.6
2-Sided
95
49.6
62.8
Superiority
OG001
OG002
Primary
Percentage of Participants With a Physician's Global Assessment (PGA) Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 12 (Base Study)
The PGA is used to determine the overall severity of a participant's psoriasis lesions at a given time point. Overall lesions will be graded for thickness, 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 1. 2 =Mild, majority of lesions have individual scores that average 2. 3= Moderate, 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.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Posted
Number
Percentage of Participants
Baseline and Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
Primary
Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Posted
Count of Participants
Participants
Up to 12 weeks
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Units
Primary
Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study)
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Posted
Count of Participants
Participants
Up to 12 weeks
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Primary
Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study)
A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug.
Analysis population included all randomized participants who received at least 1 dose of study medication during Weeks 0 to 12 based on the treatment actually received.
Posted
Count of Participants
Participants
Up to 12 weeks
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Units
Counts
Participants
Secondary
Percentage of Participants With PASI-90 Response At Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-90 response indicates the number of participants achieving a 90% reduction in PASI score compared to baseline.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Posted
Number
Percentage of participants
Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Secondary
Percentage of Participants With PASI-100 Response at Week 12
The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the amount of body surface for each region involved (head=0.1; upper limbs=0.2; trunk= 0.3; and lower limbs=0.4) and the degree of involvement for each body region (0=no involvement to 6=90-100% involvement). Calculated PASI score ranges from 0 to 72, with higher score indicating more severe disease status. The PASI-100 response indicates the number of participants achieving a 100% reduction in PASI score compared to baseline.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12.
Posted
Number
Percentage of participants
Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Secondary
Baseline Dermatology Life Quality Index (DLQI) Score
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have baseline DLQI measurement
Posted
Mean
Standard Deviation
Score on a scale
Baseline
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Secondary
Change From Baseline in the Participant DLQI Score at Week 12
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life. For a change from baseline, a larger negative number correlates with a greater improvement in the DLQI score.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have at least one DLQI measurement (post-baseline or baseline).
Posted
Least Squares Mean
95% Confidence Interval
Score on a scale
Baseline and Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Secondary
Percentage of Participants With DLQI Score of 0 or 1 at Week 12
The DLQI questionnaire consists of 10 questions, where each question is scored from 0 (not affected at all) to 3 (very much affected). The DLQI score is the sum of the 10 individual question scores and ranges from 0 to 30, with lower scores indicating better quality of life.
Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12 and have a DLQI measurement at Week 12 (or end of trial if prior to Week 12).
Posted
Number
Percentage of participants
Week 12 (or end of trial if prior to Week 12)
ID
Title
Description
OG000
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered subcutaneously (SC) once a week at Weeks 0 and 4 and then every 12 weeks.
OG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered SC once a week at Weeks 0 and 4 and then every 12 weeks.
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Time Frame
Up to 84 weeks including a 20-week follow-up period (Part 1: Week 0 to Week 12; Part 2: Week 12 to Week 28; Part 3, Week 28 to Week 64)
Description
Part 1 includes all randomized participants who received at least 1 dose of Part 1 study drug, based on the treatment received. Part 2 includes all randomized participants who received at least 1 dose of Part 2 study drug, based on the treatment received, including those on placebo re-randomized at Week 12 to tildrakizumab. Part 3 includes all participants who received at least 1 dose of Part 3 study drug, based on the treatment received, including those re-randomized to placebo during Part 3.
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
Tildrakizumab 200 mg (Part 1)
Tildrakizumab 200 mg administered once a week at Weeks 0 and 4.
0
308
8
308
35
308
EG001
Tildrakizumab 100 mg (Part 1)
Tildrakizumab 100 mg administered once a week at Weeks 0 and 4.
0
309
5
309
36
309
EG002
Placebo (Part 1)
Placebo administered once a week at Weeks 0 and 4.
0
155
1
154
23
154
EG003
Tildrakizumab 200 mg (Part 2)
Tildrakizumab 200 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 200 mg).
0
298
8
370
38
370
EG004
Tildrakizumab 100 mg (Part 2)
Tildrakizumab 100 mg administered once a week at Week 16 (includes placebo participants re-randomized at Week 12 to receive tildrakizumab 100 mg). Includes 1 participant who did not enter Part 2, but received an unscheduled dose at Week 12.
0
299
7
374
42
374
EG005
Tildrakizumab 200 mg (Part 3)
Participants received tildrakizumab 200 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
0
279
21
360
86
360
EG006
Tildrakizumab 100 mg (Part 3)
Participants received tildrakizumab 100 mg (depending on their PASI response) at Weeks 28, 40, 52, and 64 (includes participants re-randomized to placebo during Part 3).
1
19
14
316
78
316
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0011 events1 affected309 at risk
EG0020 events0 affected154 at risk
EG0030 events0 affected370 at risk
EG0040 events0 affected374 at risk
EG0050 events0 affected360 at risk
EG0060 events0 affected316 at risk
Coronary artery disease
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Salivary gland enlargement
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0011 events1 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Epiglottitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0021 events1 affected154 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0011 events1 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0001 events1 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0011 events1 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0011 events1 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Bone tuberculosis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Cataract
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Gastroenteritis salmonella
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Benign biliary neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Bowen's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Carcinoma in situ of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Cerebellar infarction
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Uterine haemorrhage
Reproductive system and breast disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Aneurysm
Vascular disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0010 events0 affected309 at risk
EG0020 events0 affected154 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG00020 events20 affected308 at risk
EG00126 events24 affected309 at risk
EG0028 events8 affected154 at risk
EG00318 events17 affected370 at risk
EG00424 events24 affected374 at risk
EG00555 events44 affected360 at risk
EG00666 events48 affected316 at risk
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 19.1
Systematic Assessment
EG0000 events0 affected308 at risk
EG0012 events2 affected309 at risk
EG0028 events8 affected154 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 19.1
Systematic Assessment
EG00015 events15 affected308 at risk
EG00110 events10 affected309 at risk
EG00210 events9 affected154 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 that report any results of the trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Head-Clinical Development
Sun Pharma Advanced Research Company Limited
912266455645
clinical.trials@sparcmail.com
ID
Term
C000598434
tildrakizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
3 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG00562 subjects
FG00667 subjects
0 subjects
FG00510 subjects
FG0067 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Lack of Efficacy
FG0003 subjects
FG0010 subjects
FG00211 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0063 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
Non-Compliance with Study Drug
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Progressive Disease
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0005 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0062 subjects
Other Protocol Specified Criteria
FG0006 subjects
FG0010 subjects
FG00210 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
0 subjects
FG00559 subjects
FG00665 subjects
0 subjects
FG0053 subjects
FG0062 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lack of Efficacy
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lost to Follow-up
FG0003 subjects
FG0014 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Non-Compliance with Study Drug
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Physician Decision
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Withdrawal by Subject
FG0004 subjects
FG0017 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0061 subjects
Other Protocol Specified Criteria
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
772
Title
Measurements
BG00046.9± 13.16
BG00146.4± 13.09
BG00247.9± 13.55
BG00346.9± 13.21
155
ParticipantsBG003772
Title
Measurements
Female
BG00082
BG001102
BG00255
BG003239
Male
BG000226
BG001207
BG002100
BG003533
155
ParticipantsBG003772
Title
Measurements
Hispanic or Latino
BG00037
BG00134
BG00219
BG00390
Not Hispanic or Latino
BG000271
BG001275
BG002135
BG003681
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
309
ParticipantsBG002154
ParticipantsBG003771
Title
Measurements
<3
BG0000
BG0011
BG0020
BG0031
3
BG000202
BG001206
BG002111
BG003519
4
BG00095
BG00195
BG00241
BG003231
5
BG00011
BG0017
BG0022
BG00320
155
ParticipantsBG003772
Title
Measurements
<=90 kg
BG000182
BG001183
BG00293
BG003458
>90 kg
BG000126
BG001126
BG00262
BG003314
155
ParticipantsBG003772
Title
Measurements
Yes
BG00071
BG00171
BG00235
BG003177
No
BG000237
BG001238
BG002120
BG003595
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
58.0
2-Sided
95
51.0
64.1
Superiority
OG002
Placebo (Part 1)
Matching placebo administered SC once a week at Weeks 0 and 4.
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG00059.1
OG00157.9
OG0027.1
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
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
52.1
2-Sided
95
44.8
58.5
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
50.9
2-Sided
95
43.6
57.4
Superiority
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG000130
OG001146
OG00274
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG0005
OG0010
OG0021
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG0002
OG0010
OG0020
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG00035.4
OG00134.6
OG0022.6
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
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
32.9
2-Sided
95
26.8
38.8
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
32.1
2-Sided
95
25.9
38.0
Superiority
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG00014.0
OG00113.9
OG0021.3
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
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
12.7
2-Sided
95
8.3
17.2
Superiority
OG001
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
12.7
2-Sided
95
8.0
17.3
Superiority
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG00013.2± 6.87
OG00113.9± 6.68
OG00213.2± 7.25
Units
Counts
Participants
OG000308
OG001309
OG002154
Title
Denominators
Categories
Title
Measurements
OG000-10.0(-10.7 to -9.4)
OG001-9.8(-10.4 to -9.1)
OG002-2.3(-3.1 to -1.5)
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
OG002
Constrained Longitudinal Data Analysis
Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
<0.001
Difference in least squares means
-7.7
2-Sided
95
-8.6
-6.8
Other
OG001
OG002
Constrained Longitudinal Data Analysis
Terms for time, the interaction of time by treatment, body weight (<=90 kg, >90 kg), and prior exposure to biologic therapy for psoriasis (yes/no).
<0.001
Difference in least squares means
-7.4
2-Sided
95
-8.3
-6.5
Other
Units
Counts
Participants
OG000299
OG001304
OG002150
Title
Denominators
Categories
Title
Measurements
OG00044.2
OG00141.5
OG0025.3
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
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.
<0.001
Difference in percentages
38.9
2-Sided
95
31.9
45.4
Other
OG001
OG002
Cochran-Mantel-Haenszel
Stratified by body weight (<=90kg, >90kg) and prior exposure to biologic therapy for psoriasis (yes/no). P-values are not adjusted for multiplicity.