A Study to Evaluate Safety and Efficacy of Toreforant (JNJ-38518168) in Participants With Moderate to Severe Plaque-type Psoriasis

NCT ID: NCT02295865

Last Updated: 2017-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-17
• Study Completion Date: 2016-03-11

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of JNJ-38518168 in participants with moderate to severe plaque-type psoriasis (common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches).

Detailed Description

This is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), parallel-group, placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect) study. The study consists of Screening Phase (maximum of 42 days prior to Week 0), Treatment Phase (Week 0-12) and Follow-up Phase (up to Week 16). Participants will be randomly assigned to receive JNJ-38518168 (3 milligram [mg] or 30 mg or 60 mg) or placebo once daily. The initial group of the participants will be randomized to either JNJ-38518168 30 mg or placebo. The dose assignments for the subsequent participants will depend on the results of up to 2 interim analyses. Efficacy will be primarily assessed by percentage of participants who achieve a Psoriasis Area and Severity Index (PASI) 75 response at Week 12. Participants' safety will be monitored throughout the study.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-38518168 60 mg

Participants will receive two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, together with one 30 mg matching placebo tablet and one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks.

Group Type: EXPERIMENTAL

JNJ-38518168 60 mg

Intervention Type: DRUG

Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily.

Placebo

Intervention Type: DRUG

Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.

JNJ-38518168 30 mg

Participants will receive one tablet of JNJ-38518168, 30 mg, together with two 30 mg matching placebo tablets and one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks.

Group Type: EXPERIMENTAL

JNJ-38518168 30 mg

Intervention Type: DRUG

One tablet of JNJ-38518168, 30 mg, orally, once daily.

Placebo

Intervention Type: DRUG

Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.

JNJ-38518168 3 mg

Participants will receive one tablet of JNJ-38518168, 3 mg, together with three 30 mg matching placebo tablets, orally, once daily, for 12 Weeks.

Group Type: EXPERIMENTAL

JNJ-38518168 3 mg

Intervention Type: DRUG

One tablet of JNJ-38518168, 3 mg, orally, once daily.

Placebo

Intervention Type: DRUG

Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.

Placebo

Participants will receive three tablets of JNJ-38518168, 30 mg matching placebo, together with one 3 mg matching placebo tablet, orally, once daily, for 12 Weeks.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.

Interventions

JNJ-38518168 60 mg

Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily.

Intervention Type: DRUG

JNJ-38518168 30 mg

One tablet of JNJ-38518168, 30 mg, orally, once daily.

Intervention Type: DRUG

JNJ-38518168 3 mg

One tablet of JNJ-38518168, 3 mg, orally, once daily.

Intervention Type: DRUG

Placebo

Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.

Intervention Type: DRUG

Other Intervention Names

Toreforant; Toreforant; Toreforant

Eligibility Criteria

Inclusion Criteria

• Participant must have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis [PsA]) for at least 6 months before the first administration of study drug
• Participant must have a Psoriasis Area and Severity Index (PASI) Greater Than or equal to (>=) 12 at screening and at baseline
• Participant must have an Investigator's Global Assessment (IGA) >=3 at screening and at baseline
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0
• A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study and for 4 months after receiving the last administration of study drug. All men must also agree to not donate sperm during the study and for 4 months after receiving the last administration of study drug

Exclusion Criteria

• Participant has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
• Participant has a current malignancy or history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 3 months before the first study drug administration, or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 1 year before the first study drug administration)
• Participant has a history of lymphoproliferative disease, including lymphoma; a history of monoclonal gammopathy of undetermined significance (MGUS); or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy or splenomegaly
• Participant has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (recurrent pyelonephritis or chronic nonremitting cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
• Participant has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced
• Participant has ever received any previous biologic therapy for psoriasis or psoriatic arthritis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Los Angeles, California, United States

Santa Monica, California, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Plainfield, Indiana, United States

Louisville, Kentucky, United States

Portland, Oregon, United States

Johnston, Rhode Island, United States

San Antonio, Texas, United States

Spokane, Washington, United States

Bydgoszcz, , Poland

Lodz, , Poland

Warsaw, , Poland

Countries

United States; Poland

Other Identifiers

38518168PSO2001

Identifier Type: OTHER

Identifier Source: secondary_id

2015-000277-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR106239

Identifier Type: -

Identifier Source: org_study_id