Phase 3
Completed N=772
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)
Source: ClinicalTrials.gov NCT01722331 ↗Enrolled (actual)
772
Serious AEs
2.9%
Results posted
Jun 2018
Primary outcomePrimary: Percentage of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) — 62.3; 63.8; 5.8 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 subcutaneous tildrakizumab (MK-3222), followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.
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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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 Japanese patients with moderate to severe plaque psoriasis: Results from a 64-week phase 3 study (reSURFACE 1).
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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 With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 (Base Study) |
62.3; 63.8; 5.8 | <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 (Base Study) |
59.1; 57.9; 7.1 | <0.001 sig |
| PRIMARY Number of Participants Experiencing an Adverse Event Up to Week 12 (Base Study) |
130; 146; 74 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an Adverse Event Up to Week 12 (Base Study) |
5; 0; 1 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to a Drug-Related Adverse Event (Base Study) |
2; 0; 0 | — |
| SECONDARY Percentage of Participants With PASI-90 Response At Week 12 |
35.4; 34.6; 2.6 | <0.001 sig |
| SECONDARY Percentage of Participants With PASI-100 Response at Week 12 |
14.0; 13.9; 1.3 | <0.001 sig |
| SECONDARY Baseline Dermatology Life Quality Index (DLQI) Score |
13.2; 13.9; 13.2 | — |
| SECONDARY Change From Baseline in the Participant DLQI Score at Week 12 |
-10.0; -9.8; -2.3 | <0.001 sig |
| SECONDARY Percentage of Participants With DLQI Score of 0 or 1 at Week 12 |
44.2; 41.5; 5.3 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Clinical diagnosis of moderate-to-severe plaque psoriasis for at least 6 months prior to study enrollment
- A candidate for phototherapy or systemic therapy
- For the extension study: must have completed Part 3 of the base study
- For the extension study: must have achieved at least a PASI-50 response by the end of Part 3 of the base study
- For the extension study: must have received active tildrakizumab (MK-3222) treatment within 12 weeks prior to the end of Part 3 of the base study
- Premenopausal female participants must agree to abstain from heterosexual activity or use a medically accepted method of contraception or use appropriate effective contraception as per local regulations or guidelines
- If enrolled at a Japanese site, participants with psoriatic arthritis using non-steroidal anti-inflammatory drugs (NSAIDs) must be on a stable dose for at least 4 weeks prior to the first dose of study drug and must not be expected to require an increase in dose over the course of the study
Exclusion Criteria
- Has erythrodermic psoriasis, predominantly pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
- Current or history of severe psoriatic arthritis and is well-controlled on current treatment
- Women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
- Expected to require topical treatment, phototherapy, or systemic treatment during the trial
- Presence of any infection
- History of recurrent infection requiring treatment with systemic antibiotics within 2 weeks of screening
- Previous use of tildrakizumab (MK-3222) or other IL-23/Th-17 pathway inhibitors including P40, p19, and IL-17 antagonists
- Evidence of active or untreated latent tuberculosis (TB)
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- At Japanese sites, positive test for HBs antibody and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)
- At Japanese sites, positive test for the Hepatitis B core (HBc) antibody and HBV DNA
- For the extension study: women of child-bearing potential who are pregnant, intend to become pregnant within 6 months of completing the trial, or who are breast feeding
- For the extension study: active or uncontrolled significant organ dysfunction or clinically significant laboratory abnormalities
- For the extension study: expected to require topical treatment, phototherapy, or systemic treatment during the extension study
- At Japanese sites, abnormal for Beta D Glucan and/or KL-6 test result(s) at the screening visit.
Data sourced from ClinicalTrials.gov (NCT01722331) 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.