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Trial record 4 of 4 for:    MK-3222

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01225731
Recruitment Status : Completed
First Posted : October 21, 2010
Results First Posted : March 30, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Psoriasis
Interventions Biological: tildrakizumab
Drug: Placebo
Enrollment 355
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up
Hide Arm/Group Description Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 Participants receive placebo, SC, at Weeks 0 and 4 Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug.
Period Title: Part 1
Started 42 92 89 86 46 0 0 0 0 0 0 0 0
Completed 40 87 88 84 40 0 0 0 0 0 0 0 0
Not Completed 2 5 1 2 6 0 0 0 0 0 0 0 0
Reason Not Completed
Did not meet eligibility criteria             1             0             0             0             1             0             0             0             0             0             0             0             0
Adverse Event             1             2             1             1             1             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             3             0             0             4             0             0             0             0             0             0             0             0
Protocol Violation             0             0             0             1             0             0             0             0             0             0             0             0             0
Period Title: Part 2
Started 0 [1] 0 [1] 0 [1] 0 [1] 0 [2] 13 [3] 94 [3] 153 [3] 79 [3] 0 0 0 0
Completed 0 0 0 0 0 10 86 128 68 0 0 0 0
Not Completed 0 0 0 0 0 3 8 25 11 0 0 0 0
Reason Not Completed
Protocol Violation             0             0             0             0             0             1             0             0             1             0             0             0             0
Adverse Event             0             0             0             0             0             0             4             4             2             0             0             0             0
Lack of Efficacy             0             0             0             0             0             1             0             12             3             0             0             0             0
Pregnancy             0             0             0             0             0             0             1             0             1             0             0             0             0
Lost to Follow-up             0             0             0             0             0             0             0             3             1             0             0             0             0
Physician Decision             0             0             0             0             0             0             0             2             2             0             0             0             0
Withdrawal by Subject             0             0             0             0             0             1             3             4             1             0             0             0             0
[1]
Participants could progress into Part 2
[2]
Participants could progress into Part 2; no placebo was given in Part 2
[3]
Participants were reassigned based on PASI score at Week 16
Period Title: Part 3
Started 0 0 0 0 0 0 [1] 0 [1] 0 [1] 0 [1] 10 [2] 86 [2] 126 [2] 67 [2]
Completed 0 0 0 0 0 0 0 0 0 10 80 116 60
Not Completed 0 0 0 0 0 0 0 0 0 0 6 10 7
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             0             0             1             1             0
Lost to Follow-up             0             0             0             0             0             0             0             0             0             0             1             2             1
Physician Decision             0             0             0             0             0             0             0             0             0             0             0             1             2
Withdrawal by Subject             0             0             0             0             0             0             0             0             0             0             4             6             4
[1]
Participants could enter the follow-up period
[2]
Not all participants entered follow-up
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Total
Hide Arm/Group Description Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 Participants receive placebo, SC, at Weeks 0 and 4 Total of all reporting groups
Overall Number of Baseline Participants 42 92 89 86 46 355
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 42 participants 92 participants 89 participants 86 participants 46 participants 355 participants
43.2  (12.9) 46.3  (13.7) 45.5  (12.8) 43.2  (12.6) 45.9  (11.7) 44.9  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 92 participants 89 participants 86 participants 46 participants 355 participants
Female
11
  26.2%
32
  34.8%
13
  14.6%
21
  24.4%
8
  17.4%
85
  23.9%
Male
31
  73.8%
60
  65.2%
76
  85.4%
65
  75.6%
38
  82.6%
270
  76.1%
1.Primary Outcome
Title Percentage of Participants With a Psoriasis Area and Severity Index (PASI)75 Response at Week 16
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Measure Type: Number
Unit of Measure: Percentage of participants
33.33 64.44 66.29 74.42 4.44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 5 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 28.89
Confidence Interval (2-Sided) 95%
13.41 to 44.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 25 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 60.00
Confidence Interval (2-Sided) 95%
48.42 to 71.58
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 100 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 61.85
Confidence Interval (2-Sided) 95%
50.33 to 73.37
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 69.97
Confidence Interval (2-Sided) 95%
58.96 to 80.99
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Experiencing Adverse Events
Hide Description 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.
Time Frame Up to 72 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants receiving at least one dose of study drug.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
Participants are followed for up to 20 weeks after the last dose of study drug
Participants are followed for up to 20 weeks after the last dose of study drug
Participants are followed for up to 20 weeks after the last dose of study drug
Participants are followed for up to 20 weeks after the last dose of study drug
Overall Number of Participants Analyzed 42 91 89 86 45 13 94 153 79 10 86 126 67
Measure Type: Number
Unit of Measure: Participants
30 56 58 54 31 7 60 105 52 3 32 53 28
3.Primary Outcome
Title Number of Particpants Discontinuing Study Treatment Due to Adverse Events
Hide Description 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.
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All particpants receiving at least one dose of study drug during the treatment period.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
Overall Number of Participants Analyzed 42 91 89 86 45 13 94 153 79
Measure Type: Number
Unit of Measure: Participants
1 2 1 1 1 0 5 5 3
4.Secondary Outcome
Title Percentage of Participants With a PASI 75 Response at Week 12
Hide Description 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.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Measure Type: Number
Unit of Measure: Percentage of participants
23.81 58.89 60.67 72.09 4.44
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 5 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 19.37
Confidence Interval (2-Sided) 95%
5.15 to 33.58
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 25 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 54.44
Confidence Interval (2-Sided) 95%
42.63 to 66.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 100 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 56.23
Confidence Interval (2-Sided) 95%
44.43 to 68.03
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 67.65
Confidence Interval (2-Sided) 95%
56.42 to 78.88
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Participants With Physician’s Global Assessment (PGA) of “Cleared” or “Minimal” at Week 16
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Measure Type: Number
Unit of Measure: Percentage of participants
33.33 57.78 61.80 74.42 2.22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 5 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 31.11
Confidence Interval (2-Sided) 95%
16.22 to 46.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 25 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 55.56
Confidence Interval (2-Sided) 95%
44.48 to 66.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 100 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 59.58
Confidence Interval (2-Sided) 95%
48.60 to 70.55
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 1: Tildrakizumab 200 mg, Part 1: Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline weight (≤90 kg or >90 kg) and prior use of biologics for psoriasis (Yes/No).
Method of Estimation Estimation Parameter % Difference in Response Rate
Estimated Value 72.20
Confidence Interval (2-Sided) 95%
62.02 to 82.37
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Participants With PASI 90 Response at Week 16
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 40 87 88 84 41
Measure Type: Number
Unit of Measure: Percentage of participants
12.50 25.29 38.64 52.38 2.44
7.Secondary Outcome
Title Percentage of Participants With PASI 100 Response at Week 16
Hide Description 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.
Time Frame Week 16
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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
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 40 87 88 84 41
Measure Type: Number
Unit of Measure: Percentage of participants
5.0 9.20 14.77 16.67 0.00
8.Secondary Outcome
Title PASI 75 Response Rate by Time
Hide Description 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.
Time Frame Up to 16 Weeks
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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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Measure Type: Number
Unit of Measure: Percentage of participants
Week 2 (n=42, 89, 89, 85, 45) 0.00 1.12 1.12 0.00 0.00
Week 4 (n=42, 89, 89, 85, 45) 0.00 11.24 11.24 3.53 0.00
Week 6 (n=40, 86, 88, 84,44) 12.50 20.93 25.00 30.95 2.27
Week 8 (n=40, 88, 87, 83, 43) 12.50 35.23 47.13 61.45 4.65
Week 12 (n=40, 87, 88, 83, 42) 25.00 59.77 61.36 73.49 4.76
Week 16 (n=40, 87, 88, 84, 41) 35.00 65.52 67.05 76.19 4.88
9.Secondary Outcome
Title Mean Change From Baseline in PASI Score at Weeks 12 and 16
Hide Description 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).
Time Frame Baseline and Weeks 12 and 16
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Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
Week 12
-10.2
(-12.5 to -7.9)
-14.4
(-16.0 to -12.9)
-14.1
(-15.7 to -12.5)
-14.9
(-16.5 to -13.3)
-2.2
(-4.4 to 0.00)
Week 16
-10.0
(-12.3 to -7.6)
-14.6
(-16.2 to -13.0)
-14.9
(-16.5 to -13.3)
-15.6
(-17.2 to -14.0)
-2.4
(-4.7 to -0.2)
10.Secondary Outcome
Title Percentage of Participants With PASI 50 Response at Week 16
Hide Description 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.
Time Frame Week 16
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Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 42 90 89 86 45
Measure Type: Number
Unit of Measure: Percentage of participants
57.14 82.22 82.02 91.86 8.89
11.Secondary Outcome
Title Mean Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 16
Hide Description 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.
Time Frame Week 16
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Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 40 87 88 83 42
Mean (95% Confidence Interval)
Unit of Measure: Score on a scale
-4.9
(-7.0 to -2.8)
-9.2
(-10.6 to -7.7)
-8.5
(-9.9 to -7.1)
-8.8
(-10.3 to -7.4)
1.0
(-1.1 to 3.0)
12.Secondary Outcome
Title Percentage of Participants Achieving DLQI Score of 0 or 1 at Week 16
Hide Description 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.
Time Frame Week 16
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Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 40 87 88 83
Measure Type: Number
Unit of Measure: Percentage of participants
32.5 57.47 52.27 57.83
13.Secondary Outcome
Title Percentage of Participants Achieving a >=5 Point Reduction in DLQI at Week 16
Hide Description 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.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo
Hide Arm/Group Description:
Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
Participants receive placebo, SC, at Weeks 0 and 4
Overall Number of Participants Analyzed 40 87 88 83 42
Measure Type: Number
Unit of Measure: Percentage of participants
52.50 70.11 64.77 73.49 19.05
Time Frame Up to 72 weeks
Adverse Event Reporting Description All participants who received at least one dose of tildrakizumab or placebo.
 
Arm/Group Title Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up Placebo Follow-up
Hide Arm/Group Description Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4 Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4 Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4 Participants receive placebo, SC, at Weeks 0 and 4 Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug. Participants are followed for up to 20 weeks after the last dose of study drug. Participants who received placebo in Part 1 and did not receive additional therapy.
All-Cause Mortality
Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up Placebo Follow-up
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up Placebo Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/42 (0.00%)      1/91 (1.10%)      1/89 (1.12%)      2/86 (2.33%)      0/45 (0.00%)      0/13 (0.00%)      5/94 (5.32%)      6/153 (3.92%)      3/79 (3.80%)      0/12 (0.00%)      1/87 (1.15%)      2/137 (1.46%)      2/75 (2.67%)      1/2 (50.00%)    
General disorders                             
Death  1  0/42 (0.00%)  0 0/91 (0.00%)  0 1/89 (1.12%)  1 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Hernia  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 1/87 (1.15%)  1 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations                             
Arthritis bacterial  1  0/42 (0.00%)  0 1/91 (1.10%)  1 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Appendicitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  1 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Cellulitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 1/79 (1.27%)  1 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Epiglottitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  1 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Sinusitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 1/153 (0.65%)  1 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Soft tissue infection  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 1/75 (1.33%)  1 0/2 (0.00%)  0
Injury, poisoning and procedural complications                             
Contusion  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  2 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Lower limb fracture  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 1/79 (1.27%)  1 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Tendonn rupture  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  1 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders                             
Arthralgia  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Back pain  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 1/79 (1.27%)  1 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Bursitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 1/79 (1.27%)  1 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Psoriatic arthropathy  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 1/75 (1.33%)  1 0/2 (0.00%)  0
Arthropathy  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 0/75 (0.00%)  0 0/2 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                             
Malignant melanoma  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Malignant melanoma in situ  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  2 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Rectal cancer  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 1/153 (0.65%)  1 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders                             
Ischaemic stroke  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Thrombotic cerebral infarction  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 0/75 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders                             
Ovarian cyst  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 1/86 (1.16%)  1 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders                             
Psoriasis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders                             
Lymphoedema  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 1/86 (1.16%)  1 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Tildrakizumab 5 mg Part 1: Tildrakizumab 25 mg Part 1: Tildrakizumab 100 mg Part 1: Tildrakizumab 200 mg Part 1: Placebo Part 2: Tildrakizumab 5 mg Part 2: Tildrakizumab 25 mg Part 2: Tildrakizumab 100 mg Part 2: Tildrakizumab 200 mg Part 3: Tildrakizumab 5 mg Follow-up Part 3: Tildrakizumab 25 mg Follow-up Part 3: Tildrakizumab 100 mg Follow-up Part 3: Tildrakizumab 200 mg Follow-up Placebo Follow-up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/42 (47.62%)      35/91 (38.46%)      33/89 (37.08%)      30/86 (34.88%)      21/45 (46.67%)      7/13 (53.85%)      38/94 (40.43%)      64/153 (41.83%)      32/79 (40.51%)      3/12 (25.00%)      14/87 (16.09%)      29/137 (21.17%)      17/75 (22.67%)      1/2 (50.00%)    
Congenital, familial and genetic disorders                             
Odontogenic cyst  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders                             
Abdominal pain upper  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 1/94 (1.06%)  1 1/153 (0.65%)  1 1/79 (1.27%)  1 1/12 (8.33%)  1 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Diarrhoea  1  1/42 (2.38%)  1 5/91 (5.49%)  5 6/89 (6.74%)  7 3/86 (3.49%)  4 3/45 (6.67%)  3 0/13 (0.00%)  0 0/94 (0.00%)  0 5/153 (3.27%)  6 3/79 (3.80%)  4 0/12 (0.00%)  0 1/87 (1.15%)  1 1/137 (0.73%)  1 1/75 (1.33%)  1 0/2 (0.00%)  0
Gastric ulcer  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Gastrooesophageal reflux disease  1  0/42 (0.00%)  0 0/91 (0.00%)  0 1/89 (1.12%)  1 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 3/94 (3.19%)  3 2/153 (1.31%)  2 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 0/75 (0.00%)  0 0/2 (0.00%)  0
Hiatus hernia  1  1/42 (2.38%)  1 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
General disorders                             
Pyrexia  1  0/42 (0.00%)  0 1/91 (1.10%)  1 3/89 (3.37%)  4 0/86 (0.00%)  0 1/45 (2.22%)  1 0/13 (0.00%)  0 0/94 (0.00%)  0 3/153 (1.96%)  4 2/79 (2.53%)  2 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 0/75 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations                             
Acute tonsilitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Bronchiitis  1  3/42 (7.14%)  3 3/91 (3.30%)  3 1/89 (1.12%)  1 0/86 (0.00%)  0 2/45 (4.44%)  2 1/13 (7.69%)  2 0/94 (0.00%)  0 3/153 (1.96%)  6 2/79 (2.53%)  3 0/12 (0.00%)  0 2/87 (2.30%)  2 0/137 (0.00%)  0 2/75 (2.67%)  2 0/2 (0.00%)  0
Diverticulitis  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Ear infection  1  0/42 (0.00%)  0 1/91 (1.10%)  1 0/89 (0.00%)  0 1/86 (1.16%)  1 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 1/87 (1.15%)  1 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Folliculitis  1  0/42 (0.00%)  0 1/91 (1.10%)  1 1/89 (1.12%)  1 2/86 (2.33%)  4 1/45 (2.22%)  1 1/13 (7.69%)  1 0/94 (0.00%)  0 1/153 (0.65%)  1 1/79 (1.27%)  1 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 2/75 (2.67%)  2 0/2 (0.00%)  0
Gastroenteritis  1  2/42 (4.76%)  2 0/91 (0.00%)  0 3/89 (3.37%)  3 3/86 (3.49%)  3 1/45 (2.22%)  1 1/13 (7.69%)  1 5/94 (5.32%)  5 4/153 (2.61%)  5 5/79 (6.33%)  5 0/12 (0.00%)  0 1/87 (1.15%)  1 1/137 (0.73%)  1 1/75 (1.33%)  1 0/2 (0.00%)  0
Nasopharyngitis  1  7/42 (16.67%)  9 12/91 (13.19%)  14 13/89 (14.61%)  15 11/86 (12.79%)  11 9/45 (20.00%)  10 3/13 (23.08%)  4 24/94 (25.53%)  32 34/153 (22.22%)  42 13/79 (16.46%)  21 0/12 (0.00%)  0 6/87 (6.90%)  9 12/137 (8.76%)  13 5/75 (6.67%)  6 0/2 (0.00%)  0
Rhinitis  1  1/42 (2.38%)  1 1/91 (1.10%)  1 2/89 (2.25%)  2 2/86 (2.33%)  2 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 2/153 (1.31%)  2 3/79 (3.80%)  3 0/12 (0.00%)  0 1/87 (1.15%)  1 1/137 (0.73%)  1 2/75 (2.67%)  2 0/2 (0.00%)  0
Upper Respiratory Tract Infection  1  2/42 (4.76%)  3 0/91 (0.00%)  0 3/89 (3.37%)  3 2/86 (2.33%)  2 0/45 (0.00%)  0 0/13 (0.00%)  0 3/94 (3.19%)  5 6/153 (3.92%)  7 4/79 (5.06%)  5 0/12 (0.00%)  0 2/87 (2.30%)  2 3/137 (2.19%)  3 3/75 (4.00%)  3 0/2 (0.00%)  0
Injury, poisoning and procedural complications                             
Contusion  1  0/42 (0.00%)  0 2/91 (2.20%)  2 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 1/94 (1.06%)  1 0/153 (0.00%)  0 2/79 (2.53%)  2 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 0/75 (0.00%)  0 0/2 (0.00%)  0
Injury  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Investigations                             
Blood pressure systolic increased  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Hypercholesterolaemia  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 1/86 (1.16%)  1 0/45 (0.00%)  0 1/13 (7.69%)  1 1/94 (1.06%)  1 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders                             
Back pain  1  1/42 (2.38%)  1 4/91 (4.40%)  4 3/89 (3.37%)  4 3/86 (3.49%)  4 0/45 (0.00%)  0 0/13 (0.00%)  0 4/94 (4.26%)  5 8/153 (5.23%)  8 3/79 (3.80%)  3 1/12 (8.33%)  1 3/87 (3.45%)  4 5/137 (3.65%)  5 1/75 (1.33%)  1 0/2 (0.00%)  0
Nervous system disorders                             
Headache  1  3/42 (7.14%)  3 5/91 (5.49%)  8 6/89 (6.74%)  8 7/86 (8.14%)  8 4/45 (8.89%)  6 0/13 (0.00%)  0 3/94 (3.19%)  3 13/153 (8.50%)  17 3/79 (3.80%)  6 0/12 (0.00%)  0 1/87 (1.15%)  1 5/137 (3.65%)  7 2/75 (2.67%)  3 0/2 (0.00%)  0
Psychiatric disorders                             
Sleep disorder  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 1/13 (7.69%)  1 0/94 (0.00%)  0 0/153 (0.00%)  0 0/79 (0.00%)  0 0/12 (0.00%)  0 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                             
Cough  1  3/42 (7.14%)  3 2/91 (2.20%)  2 2/89 (2.25%)  2 1/86 (1.16%)  1 2/45 (4.44%)  2 0/13 (0.00%)  0 2/94 (2.13%)  2 5/153 (3.27%)  5 0/79 (0.00%)  0 0/12 (0.00%)  0 1/87 (1.15%)  1 1/137 (0.73%)  1 0/75 (0.00%)  0 0/2 (0.00%)  0
Dyspnoea  1  0/42 (0.00%)  0 0/91 (0.00%)  0 0/89 (0.00%)  0 0/86 (0.00%)  0 0/45 (0.00%)  0 0/13 (0.00%)  0 0/94 (0.00%)  0 2/153 (1.31%)  3 0/79 (0.00%)  0 1/12 (8.33%)  1 0/87 (0.00%)  0 0/137 (0.00%)  0 0/75 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders                             
Pruritus  1  1/42 (2.38%)  1 4/91 (4.40%)  5 0/89 (0.00%)  0 4/86 (4.65%)  6 4/45 (8.89%)  4 0/13 (0.00%)  0 1/94 (1.06%)  1 2/153 (1.31%)  2 3/79 (3.80%)  3 0/12 (0.00%)  0 0/87 (0.00%)  0 1/137 (0.73%)  1 1/75 (1.33%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01225731     History of Changes
Other Study ID Numbers: P05495
2009-017272-24 ( EudraCT Number )
MK-3222-003 ( Other Identifier: Merck Research Laboratories )
First Submitted: October 7, 2010
First Posted: October 21, 2010
Results First Submitted: March 18, 2015
Results First Posted: March 30, 2015
Last Update Posted: February 5, 2019