Phase 3
Completed N=1,090
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)
Source: ClinicalTrials.gov NCT01729754 ↗Enrolled (actual)
1,090
Serious AEs
5.4%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) — 65.6; 61.2; 5.8; 48.2 Percentage of participants — p=<0.001
◆ Published Evidence
Highly cited
555citations · ~62 / year
Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.
Summary
This study is being conducted to evaluate the efficacy and safety/tolerability of tildrakizumab (SCH 900222/MK-3222) in a population of participants with moderate-to-severe plaque psoriasis. The primary hypotheses of the study are that tildrakizumab is superior to placebo in the treatment of moderate-to-severe chronic plaque psoriasis as measured by the proportion of participants achieving >= Psoriasis Area Sensitivity Index of 75% (PASI-75) response and the proportion 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.
Linked Publications (5)
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Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.
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Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2).
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Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies.
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Efficacy and safety of tildrakizumab in patients with early- vs. late-onset psoriasis.
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Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 (Part 1) |
65.6; 61.2; 5.8; 48.2 | <0.001 sig |
| 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) |
59.2; 54.7; 4.5; 47.6 | <0.001 sig |
| PRIMARY Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 (Part 1) |
49.4; 44.3; 55.1; 54.0 | — |
| PRIMARY Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 (Part 1) |
1.0; 1.0; 1.3; 1.9 | — |
| SECONDARY Percentage of Participants Achieving a PASI-75 Response at Week 28 (Part 2) |
72.6; 73.5; 53.6 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a PASI-75 Response at Week 40 (Part 3) |
96.3; 92.6; 97.6; 63.3; 66.7; 61.9 | — |
| SECONDARY Percentage of Participants Achieving a PASI-75 Response at Week 52 (Part 3) |
97.1; 94.2; 93.6; 66.7; 78.9; 68.4 | — |
| 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) |
69.2; 64.6; 45.3 | <0.001 sig |
| 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) |
83.2; 79.2; 84.9; 57.6; 38.1; 57.1 | — |
| 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) |
84.8; 77.7; 79.4; 50.8; 42.1; 57.9 | — |
| SECONDARY Percentage of Participants Achieving a PASI-90 Response at Week 12 (Part 1) |
36.6; 38.8; 1.3; 21.4 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a PASI-90 Response at Week 28 (Part 2) |
57.7; 55.5; 30.7 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a PASI-90 Response at Week 40 (Part 3) |
76.6; 73.1; 78.8; 28.3; 23.8; 42.9 | — |
| SECONDARY Percentage of Participants Achieving a PASI-90 Response at Week 52 (Part 3) |
81.9; 68.3; 78.4; 31.7; 26.3; 42.1 | — |
| SECONDARY Percentage of Participants Achieving a PASI-100 Response at Week 12 (Part 1) |
11.8; 12.4; 0; 4.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a PASI-100 Response at Week 28 (Part 2) |
27.0; 22.8; 11.2 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving a PASI-100 Response at Week 40 (Part 3) |
39.3; 38.9; 33.5; 11.7; 0; 14.3 | — |
| SECONDARY Percentage of Participants Achieving a PASI-100 Response at Week 52 (Part 3) |
46.7; 37.5; 35.3; 10.0; 5.3; 31.6 | — |
| SECONDARY Baseline Dermatology Life Quality Index (DLQI) |
13.2; 14.8; 13.7; 14.5 | — |
| SECONDARY Change From Baseline in the DLQI at Week 12 (Part 1) |
-10.3; -10.2; -2.0; -8.9 | <0.001 sig |
| SECONDARY Change From Baseline in the DLQI at Week 28 (Part 2) |
-11.7; -11.2; -9.5 | <0.001 sig |
| SECONDARY Change From Baseline in the DLQI at Week 40 (Part 3) |
-11.6; -12.0; -13.2; -9.7; -9.0; -9.8 | — |
| SECONDARY Change From Baseline in the DLQI at Week 52 (Part 3) |
-11.3; -11.5; -13.1; -9.2; -9.4; -9.3 | — |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Week 12 (Part 1) |
47.4; 40.2; 8.0; 35.5 | <0.001 sig |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Week 28 (Part 2) |
65.0; 54.1; 39.4 | <0.001 sig |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Week 40 (Part 3) |
72.2; 68.5; 71.2; 41.7; 9.5; 19.0 | — |
| SECONDARY Percentage of Participants With a DLQI Score of 0 or 1 at Week 52 (Part 3) |
72.4; 71.4; 68.8; 40.0; 10.5; 42.1 | — |
| SECONDARY Mean Change From Baseline in PASI Score Over Time (Part 1) |
-8.1; -7.9; -2.3; -7.0; -13.1; -12.8 | — |
| SECONDARY Mean Change From Baseline in PASI Score Over Time (Part 2) |
-16.2; -15.9; -14.2; -11.6; -9.6; -17.1 | — |
| SECONDARY Mean Change From Baseline in PASI Score Over Time (Part 3) |
-19.0; -19.0; -18.7; -14.0; -15.0; -15.5 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Score Over Time (Part 1) |
-40.2; -39.3; -11.7; -33.9; -65.7; -63.8 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Score Over Time (Part 2) |
-82.0; -79.3; -70.3; -59.2; -49.4; -86.6 | — |
| SECONDARY Mean Percent Change From Baseline in PASI Score Over Time (Part 3) |
-94.9; -94.0; -94.3; -77.1; -71.1; -75.3 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to enrollment;
- Candidate for phototherapy or systemic therapy;
- Premenopausal female participants must agree to abstain from heterosexual activity or use a medically approved method of contraception or use appropriate effective contraception as per local regulations or guidelines
- For the extension study: must have completed Part 3 of the base study
- For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study
Exclusion Criteria
- Non-plaque forms of psoriasis
- Presence or history of severe psoriatic arthritis and is well-controlled on current treatment regimen
- Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating
- Participant is expected to require topical therapy, phototherapy, or systemic therapy during the trial
- Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics
- Previous use of entanercept, tildrakizumab (MK-3222), or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including p40, p19, and IL-17 antagonists
- Latex allergy or sensitivity
- Active or untreated latent tuberculosis (TB)
- For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or are breast feeding
- For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
- For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study
Data sourced from ClinicalTrials.gov (NCT01729754) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.