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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)

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ClinicalTrials.gov Identifier: NCT01722331
Recruitment Status : Active, not recruiting
First Posted : November 6, 2012
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Plaque Psoriasis Drug: MK-3222 200 mg Drug: MK-3222 100 mg Drug: Matching Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 772 participants
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)
Study Start Date : December 2012
Primary Completion Date : June 2014
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of Participants With Psoriasis Area Sensitivity Index 75 (PASI-75) Response at Week 12 [ Time Frame: Week 12 ]
  2. 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 ]
  3. Number of Participants Experiencing Adverse Events (AEs) Across Study [ Time Frame: Up to Week 276 ]
  4. 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 ]
  5. Number of Participants Experiencing an AE Up to Week 12 [ Time Frame: Up to Week 12 ]
  6. 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 :
  1. Proportion of Participants With PASI-90 Response At Week 12 [ Time Frame: Week 12 ]
  2. Proportion of Participants With PASI-100 Response at Week 12 [ Time Frame: Week 12 ]
  3. Change From Baseline in the Participant Dermatology Life Quality Index (DLQI) at Week 12 [ Time Frame: Baseline, Week 12 ]
  4. Proportion of Participants With DLQI Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ]


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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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: November 6, 2012    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017

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