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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01729754
First received: November 13, 2012
Last updated: November 9, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Plaque Psoriasis
Drug: Tildrakizumab 200 mg
Drug: Tildrakizumab 100 mg
Drug: Tildrakizumab Placebo
Drug: Etanercept Placebo
Drug: Etanercept 50 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-Week, Phase 3, Randomized, Active Comparator and 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-3222-011)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentage of Participants Achieving a Psoriasis Area Sensitivity Index 75% (PASI-75) Response at Week 12 [ Time Frame: Week 12 ]
  • 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 [ Time Frame: Week 12 ]
  • Percentage of Participants Experiencing an Adverse Event (AE) Up to Week 12 [ Time Frame: Up to Week 12 ]
  • Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 12 [ Time Frame: Up to Week 12 ]
  • Percentage of Participants Experiencing an AE Up to Week 264 [ Time Frame: Up to Week 264 ]
  • Percentage of Participants Discontinuing Study Treatment Due to an AE Up to Week 244 [ Time Frame: Up to Week 244 ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving a PASI-75 Response at Weeks 28, 40, and 52 [ Time Frame: Week 28, Week 40, Week 52 ]
  • Percentage of Participants With a PGA Score of Clear or Minimal With at Least a 2 Grade Reduction From Baseline at Weeks 28, 40, and 52 [ Time Frame: Week 28, Week 40, Week 52 ]
  • Percentage of Participants Achieving a PASI-90 Response at Weeks 12, 28, 40 and 52 [ Time Frame: Week 12, Week 28, Week 40, Week 52 ]
  • Percentage of Participants Achieving a PASI-100 Response at Weeks 12, 28, 40 and 52 [ Time Frame: Week 12, Week 28, Week 40, Week 52 ]
  • Mean Change from Baseline in the Dermatology Life Quality Index (DLQI) at Weeks 12, 28, 40 and 52 [ Time Frame: Week 12, Week 28, Week 40, Week 52 ]
  • Percentage of Participants with a DLQI Score of 0 or 1 at Weeks 12, 28, 40 and 52 [ Time Frame: Week 12, Week 28, Week 40, Week 52 ]
  • Mean Change from Baseline in PASI Score Over Time [ Time Frame: Baseline through Week 244 ]
  • Mean Percent Change from Baseline in PASI Score Over Time [ Time Frame: Baseline through Week 244 ]

Enrollment: 1090
Study Start Date: February 2013
Estimated Study Completion Date: June 2019
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tildrakizumab 200 mg+Etanercept PBO
Participants receive tildrakizumab 200 mg subcutaneously (SC) on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo (PBO) twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Drug: Tildrakizumab 200 mg
Tildrakizumab 200 mg administered SC
Other Name: SCH 900222
Drug: Etanercept Placebo
Matching placebo to etanercept administered SC
Experimental: Tildrakizumab 100 mg+Etanercept PBO
Participants receive tildrakizumab 100 mg SC on Weeks 0, 4, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244, plus etanercept placebo twice weekly until Week 12 and once weekly from Week 12 to Week 28.
Drug: Tildrakizumab 100 mg
Tildrakizumab 100 mg administered SC
Other Name: SCH 900222
Drug: Etanercept Placebo
Matching placebo to etanercept administered SC
Placebo Comparator: Tildrakizumab PBO+Etanercept PBO
Participants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 plus etanercept placebo twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants will be re-randomized 1:1 at Week 12 to receive tildrakizumab 200 mg or tildrakizumab 100 mg on Weeks 12, 16, 28, 40 and 52 and, optionally, every 12 weeks thereafter until Week 244.
Drug: Tildrakizumab Placebo
Matching placebo to tildrakizumab administered SC
Drug: Etanercept Placebo
Matching placebo to etanercept administered SC
Active Comparator: Tildrakizumab PBO+Etanercept 50 mg
Participants receive matching placebo to tildrakizumab SC on Weeks 0 and 4 and etanercept 50 mg twice weekly up to Week 12 and once weekly from Week 12 to Week 28. Participants who don't achieve PASI-75, receive tildrakizumab 200 mg after Week 28 (Weeks 32, 26 and 48) and optionally every 12 weeks thereafeter until Week 244.
Drug: Tildrakizumab Placebo
Matching placebo to tildrakizumab administered SC
Drug: Etanercept 50 mg
Etanercept 50 mg administered SC
Other Name: Embrel

Detailed Description:

The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 52 weeks, and a 20-week follow-up period. The base study treatment period is divided into 3 sequential parts.

In Part 1 of the base study (Week 0 to Week 12), participants will be randomized to one of 4 study arms (Arm A: tildrakizumab 200 mg + matching placebo to etanercept; Arm B: tildrakizumab 100 mg + matching placebo to etanercept; Arm C: matching placebo to tildrakizumab + matching placebo to etanercept; Arm D: matching placebo to tildrakizumab + etanercept 50 mg).

In Part 2 of the base study (Week 12 to Week 28), participants in Arm A and Arm B will receive matching placebo to tildrakizumab to maintain blinding at Week 12 and will receive either tildrakizumab 200 mg (Arm A) or tildrakizumab 100 mg (Arm B) at Week 16. Participants in Arm A and Arm B will also receive matching placebo to etanercept once weekly through study Week 28. At study Week 12, Arm C participants will be re-randomized to receive their first dose of tildrakizumab 200 mg or tildrakizumab 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16. Participants in Arm C will also receive matching placebo to etanercept through treatment Week 28. Participants in Arm D will continue with once weekly doses of etanercept through study Week 28 in combination with matching placebo to tildrakizumab.

In Part 3 of the base study (Week 28 to Week 52), participants in Arm A with >= Psoriasis Area Sensitivity Index of 75% (PASI-75) response at Week 28 will be re-randomized to either continue tildrakizumab 200 mg or receive tildrakizumab 100 mg at study Weeks 28, 40, and 52. Participants with >= PASI-50 response but < PASI-75 response will continue to receive tildrakizumab 200 mg every 12 weeks and those participants with < PASI-50 response will be discontinued from the study. Participants in Arm B with >= PASI-75 response at Week 28 will continue to receive tildrakizumab 100 mg every 12 weeks. Those with >= PASI-50 response but < PASI-75 response will be re-randomized to receive continued tildrakizumab 100 mg or tildrakizumab 200 mg every 12 weeks. Participants in Arm B with < PASI-50 response will be discontinued from the study. Participants in Arm C will continue to receive treatment every 12 weeks according to their re-randomized treatment assignment. Participants in Arm D that achieve >= PASI-75 response at Week 28 will be discontinued from the study. Those participants with < PASI-75 response at Week 28 will be crossed over to tildrakizumab 200 mg to receive doses at Weeks 32, 36 and 48.

Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be monitored for an additional 20 weeks in the follow-up period. Each participant will receive tildrakizumab 200 mg or tildrakizumab 100 mg every 12 weeks up to study Week 244 according to their treatment assignment at the conclusion of Part 3 of the base study.

  Eligibility

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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01729754

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: NCT01729754     History of Changes
Other Study ID Numbers: 3222-011
2012-001377-88 ( EudraCT Number )
P07771 ( Other Identifier: Merck Protocol Number )
Study First Received: November 13, 2012
Last Updated: November 9, 2016

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Antibodies, Monoclonal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on March 23, 2017