Trial · NCT01722331
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)
NCT01722331, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2018-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01722331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01722331
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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 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)
- NCT number
- NCT01722331
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 772 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Plaque Psoriasis
- Interventions
- Tildrakizumab 200 mg, Tildrakizumab 100 mg, Matching Placebo
- First posted
- 2012-11-06
- Last updated
- 2022-03-23
- Other registries' IDs
- eudract:2012-002255-42
- Results first posted
- 2018-06-13
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) | Week 12 (or end of trial if prior to 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-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline. |
| 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) | Baseline and Week 12 (or end of trial if prior to 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. |
| Primary | Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) | Up to 12 weeks | 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 | Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) | Up to 12 weeks | 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 | Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) | Up to 12 weeks | A drug-related adverse event is an adverse event that has been determined by the investigator to be related to the study drug. |
| Secondary | Percentage of Participants With PASI-90 Response At Week 12 | Week 12 (or end of trial if prior to 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. |
| Secondary | Percentage of Participants With PASI-100 Response at Week 12 | Week 12 (or end of trial if prior to 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. |
| Secondary | Baseline Dermatology Life Quality Index (DLQI) Score | Baseline | 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. |
| Secondary | Change From Baseline in the Participant DLQI Score at Week 12 | Baseline and Week 12 (or end of trial if prior to 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. |
| Secondary | Percentage of Participants With DLQI Score of 0 or 1 at Week 12 | Week 12 (or end of trial if prior to 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) | Week 12 (or end of trial if prior to Week 12) | Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12. | 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 (Base Study) | Baseline and Week 12 (or end of trial if prior to Week 12) | Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12. | Percentage of Participants | NUMBER |
| PRIMARY | Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) | Up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) | Up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) | Up to 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With PASI-90 Response At Week 12 | Week 12 (or end of trial if prior to Week 12) | Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PASI-100 Response at Week 12 | Week 12 (or end of trial if prior to Week 12) | Analysis population consists of all randomized participants who received at least one dose of assigned study drug between Weeks 0 and 12. | Percentage of participants | NUMBER |
| SECONDARY | Baseline Dermatology Life Quality Index (DLQI) Score | Baseline | 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 | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in the Participant DLQI Score at Week 12 | Baseline and Week 12 (or end of trial if prior to Week 12) | 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). | Score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With DLQI Score of 0 or 1 at Week 12 | Week 12 (or end of trial if prior to Week 12) | 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). | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) | Tildrakizumab 200 mg (Part 1) | 62.3 | Percentage of Participants | ||
| Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) | Tildrakizumab 100 mg (Part 1) | 63.8 | Percentage of Participants | ||
| Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) | Placebo (Part 1) | 5.8 | 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 (Base Study) | Tildrakizumab 200 mg (Part 1) | 59.1 | 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 (Base Study) | Tildrakizumab 100 mg (Part 1) | 57.9 | 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 (Base Study) | Placebo (Part 1) | 7.1 | Percentage of Participants | ||
| Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) | Tildrakizumab 200 mg (Part 1) | 130 | Participants | ||
| Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) | Tildrakizumab 100 mg (Part 1) | 146 | Participants | ||
| Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) | Placebo (Part 1) | 74 | Participants | ||
| Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) | Tildrakizumab 200 mg (Part 1) | 5 | Participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow63
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 & 3) | 308 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 249 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1 & 2) | 41 | |
| Part 1 | STARTED | Tildrakizumab 100 mg (Parts 1 & 2)/ 200 mg (Part 3) | 19 | |
| Part 1 | STARTED | Placebo (Part 1) | 9 | |
| 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) | 74 | |
| Part 1 | COMPLETED | Tildrakizumab 200 mg (Parts 1, 2 & 3) | 298 | |
| Part 1 | COMPLETED | Tildrakizumab 100 mg (Parts 1, 2 & 3) | 249 | |
| Part 1 | COMPLETED | Tildrakizumab 100 mg (Parts 1 & 2) | 32 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 participant flowAdverse events357
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 | Nasopharyngitis | Infections and infestations | Tildrakizumab 200 mg (Part 1) | 20 | 308 | 20 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 100 mg (Part 1) | 24 | 309 | 26 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Part 1) | 8 | 154 | 8 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 200 mg (Part 2) | 17 | 370 | 18 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 100 mg (Part 2) | 24 | 374 | 24 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 200 mg (Part 3) | 44 | 360 | 55 |
| other | Nasopharyngitis | Infections and infestations | Tildrakizumab 100 mg (Part 3) | 48 | 316 | 66 |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Tildrakizumab 200 mg (Part 1) | 0 | 308 | 0 |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Tildrakizumab 100 mg (Part 1) | 2 | 309 | 2 |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Placebo (Part 1) | 8 | 154 | 8 |
1 to 10 of 357Source ClinicalTrials.gov
See all 357 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tildrakizumab 200 mg (Part 1) | 0 | 308 |
| Total, all-cause mortality | Tildrakizumab 100 mg (Part 1) | 0 | 309 |
| Total, all-cause mortality | Placebo (Part 1) | 0 | 155 |
| Total, all-cause mortality | Tildrakizumab 200 mg (Part 2) | 0 | 298 |
| Total, all-cause mortality | Tildrakizumab 100 mg (Part 2) | 0 | 299 |
| Total, all-cause mortality | Tildrakizumab 200 mg (Part 3) | 0 | 279 |
| Total, all-cause mortality | Tildrakizumab 100 mg (Part 3) | 1 | 19 |
| Total, other adverse events | Tildrakizumab 200 mg (Part 1) | 35 | 308 |
| Total, other adverse events | Tildrakizumab 100 mg (Part 1) | 36 | 309 |
| Total, other adverse events | Placebo (Part 1) | 23 | 154 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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.
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