A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous MK-3222 in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-012)

Plaque-type Psoriasis Clinical Trial

Official title:
A 28-Week, Phase 3, Randomized, Active Comparator and Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous 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-3222-012)

Status Withdrawn

Clinical Trial Summary

This study is being conducted to evaluate the efficacy and safety/tolerability of SCH 900222/MK-3222 in a population of participants with moderate-to-severe plaque psoriasis.

Clinical Trial Description

The base study consists of a screening phase of up to 4 weeks followed by a treatment period of 28 weeks, and a 20-week safety follow-up period off drug. The base study is divided into 2 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: MK-3222 200 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm B: MK-3222 100 mg at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm C: Matching placebo to MK-3222 at Week 0 and Week 4 + matching placebo to etanercept twice weekly; Arm D: Matching placebo to MK-3222 at Week 0 and Week 4 + etanercept 50 mg twice weekly). In Part 2 of the base study (Week 12 to Week 28), participants in Arm A, Arm B, and Arm D will receive matching placebo to MK-3222 to maintain blinding at Week 12. Participants in Arm A and Arm B will continue to receive either MK-3222 200 mg (Arm A) or MK-3222 100 mg (Arm B) at Week 16 and Week 28 and 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 MK-3222 200 mg or MK-3222 100 mg, and will receive additional doses of study medication according to their re-randomized treatment assignment at Week 16 and Week 28. Participants in Arm C will also receive matching placebo to etanercept once weekly 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 MK-3222. For all participants, completion of Week 28 marks completion of Part 2 and of the overall base study. Participants originally assigned to Arm D and participants who discontinue treatment prior to completing Part 2 will not be eligible to enroll in the extension. Participants that are ineligible or opt not to enter the extension study will be encouraged to complete the 20-week follow-up period. Eligible participants that choose to enroll in the extension study will have an additional treatment period of up to 192 weeks and will be followed for an additional 20 weeks in the follow-up period. Each participant will receive MK-3222 200 mg or MK-3222 100 mg every 12 weeks up to study Week 220 according to their treatment assignment at the conclusion of Part 2 of the base study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01936688
Study type	Interventional
Source	Sun Pharmaceutical Industries Limited
Contact
Status	Withdrawn
Phase	Phase 3
Start date	September 2013
Completion date	August 2018

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01636687` - Judging the Efficacy of Secukinumab in Patients With Psoriasis Using AutoiNjector: a Clinical Trial Evaluating Treatment Results (JUNCTURE)	Phase 3
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Completed	`NCT01132612` - AIN457 Regimen Finding Extension Study in Participants With Moderate to Severe Psoriasis	Phase 2
Completed	`NCT00852761` - A Study to Evaluate the Efficacy and Tolerability of Topical Therapies for the Condition of Plaque-Type Psoriasis	Phase 4
Completed	`NCT00625326` - Study of Dose-Effect of COL-121 Ointment in Patients With Plaque-Type Psoriasis	Phase 2
Completed	`NCT01412944` - Efficacy and Safety of Intravenous and Subcutaneous Secukinumab in Moderate to Severe Chronic Plaque-type Psoriasis	Phase 3
Completed	`NCT00521339` - Apremilast Safety and PK Study in Recalcitrant Plaque Psoriasis	Phase 2
Completed	`NCT01876875` - n-3 Polysaturated Fatty Acids-rich Diet in Psoriasis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.