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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01722331
First Posted: November 6, 2012
Last Update Posted: March 17, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study is being conducted to evaluate the efficacy and safety/tolerability of subcutaneous MK-3222, followed by an optional long-term safety extension study, in participants with moderate-to-severe chronic plaque psoriasis.

Condition Intervention Phase
Plaque Psoriasis Drug: MK-3222 200 mg Drug: MK-3222 100 mg Drug: Matching Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Proportion of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 [ Time Frame: Week 12 ]
  • 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 [ Time Frame: Week 12 ]
  • Number of Participants Experiencing Adverse Events (AEs) Across Study [ Time Frame: Up to Week 276 ]
  • Number of Participants Discontinuing Due to Drug-Related AEs Up to Week 12 and Across Study [ Time Frame: Up to Week 12; Up to Week 276 ]
  • Number of Participants Experiencing an AE Up to Week 12 [ Time Frame: Up to Week 12 ]
  • Number of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 and Across Study [ Time Frame: Up to Week 12; Up to Week 276 ]

Secondary Outcome Measures:
  • Proportion of Participants With PASI-90 Response At Week 12 [ Time Frame: Week 12 ]
  • Proportion of Participants With PASI-100 Response at Week 12 [ Time Frame: Week 12 ]
  • Change From Baseline in the Participant Dermatology Life Quality Index (DLQI) at Week 12 [ Time Frame: Baseline, Week 12 ]
  • Proportion of Participants With DLQI Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]

Enrollment: 772
Study Start Date: December 2012
Estimated Study Completion Date: October 2019
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-3222 200 mg
MK-3222 administered subcutaneously (SC) at a dose of 200 mg at Week 0 and Week 4, and then every 12 weeks until study end or participant discontinuation.
Drug: MK-3222 200 mg
Other Name: SCH 900222
Experimental: MK-3222 100 mg
MK-3222 administered SC at a dose of 100 mg at Week 0 and Week 4, and then every 12 weeks until study end or participant discontinuation.
Drug: MK-3222 100 mg
Other Name: SCH 900222
Placebo Comparator: Placebo
Matching placebo administered SC at Week 0 and Week 4.
Drug: Matching Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 that are pregnant, intend to become pregnant within 6 months of completing the trial, or that 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 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 (HBs Ag) 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 that are pregnant, intend to become pregnant within 6 months of completing the trial, or that 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722331


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01722331     History of Changes
Other Study ID Numbers: 3222-010
2012-002255-42 ( EudraCT Number )
P07770 ( Other Identifier: Merck Protocol Number )
132284 ( Registry Identifier: JAPIC-CTI )
First Submitted: November 2, 2012
First Posted: November 6, 2012
Last Update Posted: March 17, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases