Trial · NCT01729754
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
NCT01729754, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2018-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011). Trials, record NCT01729754. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01729754
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011)
- NCT number
- NCT01729754
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,090 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Plaque Psoriasis
- Interventions
- Tildrakizumab 200 mg, Tildrakizumab 100 mg, Tildrakizumab Placebo, Etanercept Placebo, Etanercept 50 mg
- First posted
- 2012-11-20
- Last updated
- 2026-11-05
- Other registries' IDs
- eudract:2012-001377-88
- Results first posted
- 2018-06-27
Source ClinicalTrials.gov
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | 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 area of 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. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study. |
| 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 (Part 1) | Week 12 | 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. Statistical analyses presented below compare tildrakizumab to placebo to support the primary hypothesis of the study. |
| Primary | Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) | Up to Week 12 | 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. |
| Primary | Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) | Up to Week 12 | 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. |
| Secondary | Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2) | Week 28 | The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of 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. Primary analysis for this endpoint is for participants randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or etanercept in Part 1. |
| Secondary | Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3) | Week 40 | The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of 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-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28. |
| Secondary | Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3) | Week 52 | The PASI is a measure of the average redness, thickness, and scaliness of lesions (each graded on a 0-4 scale), weighed by the area of 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-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28. |
| Secondary | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2) | Week 28 | 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. |
| Secondary | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3) | Week 40 | 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. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28. |
| Secondary | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3) | Week 52 | 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. Week-28 responder (Wk-28 R) is a participant who achieved ≥ 75% improvement in PASI from baseline at Week 28. Week-28 partial responder (Wk-28 PR) is a participant who achieved ≥50% and \<75% improvement in PASI response from baseline at Week 28. |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | Week 12 | Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned. | Percentage of participants | NUMBER |
| 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 (Part 1) | Week 12 | Analysis population includes all randomized participants who received at least 1 dose of Part 1 study treatment based on the treatment assigned. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) | Up to Week 12 | Analysis population includes participants who took at least one dose of Part 1 study drug based on the treatment actually received. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) | Up to Week 12 | Analysis population includes participants who took at least one dose of Part 1 study medication based on the treatment actually received. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2) | Week 28 | Analysis population includes all participants randomized to tildrakizumab or etanercept in Part 1 who received at least one dose of study medication in Part 2. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3) | Week 40 | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 40. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3) | Week 52 | Participants who received at least one dose of study medication in Part 3 and with valid PASI value at baseline and at Week 52. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 28 (Part 2) | Week 28 | Analysis population includes participants randomized to tildrakizumab 100 mg, tildrakizumab 200 mg, or etanercept in Part 1 who received at least one dose of study medication in Part 2. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 40 (Part 3) | Week 40 | Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 40. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Week 52 (Part 3) | Week 52 | Participants who received at least one dose of study medication in Part 3 and with valid PGA value at baseline and at Week 52. | Percentage of participants | NUMBER |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group306
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | Tildrakizumab 200 mg | 65.6 | Percentage of participants | ||
| Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | Tildrakizumab 100 mg | 61.2 | Percentage of participants | ||
| Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | Placebo | 5.8 | Percentage of participants | ||
| Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) | Etanercept 50 mg | 48.2 | Percentage of participants | ||
| 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 (Part 1) | Tildrakizumab 200 mg | 59.2 | Percentage of participants | ||
| 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 (Part 1) | Tildrakizumab 100 mg | 54.7 | Percentage of participants | ||
| 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 (Part 1) | Placebo | 4.5 | Percentage of participants | ||
| 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 (Part 1) | Etanercept 50 mg | 47.6 | Percentage of participants | ||
| Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) | Tildrakizumab 200 mg | 49.4 | Percentage of participants | ||
| Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) | Tildrakizumab 100 mg | 44.3 | Percentage of participants |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Tildrakizumab 200 mg (Parts 1 & 2) | 20 | |
| Part 1 | STARTED | Tildrakizumab 200 mg (Parts 1, 2, & 3) | 184 | |
| Part 1 | STARTED | Tildrakizumab 200 mg (Parts 1 & 2)/ 100 mg (Part 3) | 110 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1 & 2) | 18 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) | 21 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1, 2, & 3) | 268 | |
| Part 1 | STARTED | Placebo (Part 1) | 14 | |
| Part 1 | STARTED | Placebo (Part 1)/ Tildrakizumab 200 mg (Parts 2 & 3) | 72 | |
| Part 1 | STARTED | Placebo (Part 1)/ Tildrakizumab 100 mg (Parts 2 & 3) | 70 | |
| Part 1 | STARTED | Etanercept 50 mg (Parts 1 & 2)/ Tildrakizumab 200 mg (Part 3) | 313 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events328
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site erythema | General disorders | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 5 | 527 | 7 |
| other | Injection site erythema | General disorders | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 5 | 487 | 5 |
| other | Injection site erythema | General disorders | Placebo (Part 1) | 1 | 156 | 2 |
| other | Injection site erythema | General disorders | Etanercept 50 mg (Parts 1 & 2) | 28 | 313 | 98 |
| other | Injection site reaction | General disorders | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 4 | 527 | 8 |
| other | Injection site reaction | General disorders | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 2 | 487 | 2 |
| other | Injection site reaction | General disorders | Placebo (Part 1) | 1 | 156 | 1 |
| other | Injection site reaction | General disorders | Etanercept 50 mg (Parts 1 & 2) | 17 | 313 | 54 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 119 | 527 | 173 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 112 | 487 | 152 |
1 to 10 of 328Source ClinicalTrials.gov
See all 328 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 0 | 527 |
| Total, all-cause mortality | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 3 | 487 |
| Total, all-cause mortality | Placebo (Part 1) | 0 | 156 |
| Total, all-cause mortality | Etanercept 50 mg (Parts 1 & 2) | 0 | 313 |
| Total, other adverse events | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 167 | 527 |
| Total, other adverse events | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 151 | 487 |
| Total, other adverse events | Placebo (Part 1) | 23 | 156 |
| Total, other adverse events | Etanercept 50 mg (Parts 1 & 2) | 118 | 313 |
| Total, serious adverse events | Tildrakizumab 200 mg (Parts 1, 2 & 3) Wk-28 R | 26 | 527 |
| Total, serious adverse events | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 30 | 487 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01729754
GET https://conductscience.org/api/trials/v1/NCT01729754/registered?page=2