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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01936688
• Other study ID #: 3222-012
• Secondary ID: MK-3222-0122013-
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2013
• Est. completion date: August 2018

Study information

• Verified date: February 2022
• Source: Sun Pharmaceutical Industries Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 2 of the base study

• For the extension study: must have achieved at least a PASI-50 response by the end of Part 2 of the base study

Exclusion Criteria:

• Non-plaque forms of psoriasis

• Presence or history of severe psoriatic arthritis that is well-controlled on current treatment regimen

• Women of childbearing potential that are pregnant, intend to become pregnant, or are lactating

• Participant is expected to require topical therapy, phototherapy, or systemic therapy

• Presence of any infection or history of recurrent infection requiring treatment with systemic antibiotics

• Previous use of MK-3222/SCH 900222, or other interleukin-23 (IL-23)/T- helper cell 17 (Th-17) pathway inhibitors including P40, P19, and IL-17 antagonists, or etanercept

• Latex allergy or sensitivity

• Active or untreated latent tuberculosis (TB)

• 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

Related Conditions & MeSH terms

• Plaque-type Psoriasis
• Psoriasis

Intervention

Drug:
• MK-3222 200 mg
MK-3222 200 mg administered SC.
• MK-3222 100 mg
MK-3222 100 mg administered SC.
• Placebo to MK-3222
Matching placebo to MK-3222 administered SC.
• Placebo to Etanercept
Matching placebo to etanercept for subcutaneous injection.
• Etanercept 50 mg
Etanercept 50 mg for subcutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharmaceutical Industries Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Achieving a Psoriasis Area Severity Index 75% (PASI-75) at Week 12		Week 12
Primary	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		Baseline, Week 12
Secondary	Proportion of Participants Achieving PASI-90 Response at Week 12 and 28		Week 12, Week 28
Secondary	Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at Week 12 and Week 28		Week 12, Week 28
Secondary	Proportion of Participants With a DLQI Score of 0 or 1 at Week 12 and Week 28		Week 12, Week 28
Secondary	Mean Change and Mean Percent Change from Baseline in PASI Score Over Time		Baseline, Up to Week 28
Secondary	Mean Change From Baseline in the Nail Area Psoriasis Severity Index (NAPSI) at Week 12 and Week 28		Week 12, Week 28
Secondary	Number of Participants Experiencing an Adverse Event (AE)		Up to Week 28
Secondary	Number of Participants Discontinuing Study Treatment Due to an AE		Up to Week 28
Secondary	Proportion of Participants Achieving PASI-100 Response at Week 12 and 28		Week 12, Week 28