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

NCT02295865 | Completed Phase 2

• 3 other identifiers: CR10623938518168PSO20012015-000277-12
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 13

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).

Conditions

Psoriasis

Keywords

Psoriasis; Toreforant; JNJ-38518168

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response at Week 12

  The PASI score is a combined assessment of lesion severity and area affected into single score. Body will be divided into 4 sections:head, arms, trunk, and legs. For each section, percent (%) area of skin involved was estimated:0=0%, 1=less than (\<) 10%, 2=10 to \<30%, 3=30 to \<50%, 4=50 to \<70%, 5=70 to \<90%, 6=90 to 100%. Severity will be estimated by clinical signs:erythema,induration,desquamation;scale:0= none to 4=maximum. Final PASI=sum of severity parameters for each section\*area score\*weight of section (head:0.1,arms:0.2,body:0.3,legs:0.4);total possible score range: 0=no disease to 72=maximal disease. A PASI 75 response defined as greater than or equal to (\>=) 75 % improvement in PASI score from baseline.

  Week 12

Secondary Outcomes (7)

• Percentage of Participants Who Achieve a Score of 0 or 1 on the Investigator's Global Assessment (IGA) at Week 12

  Week 12

• Percentage of Participants Who Achieve PASI 50, PASI 75, PASI 90 and PASI 100 Responses

  Week 0, 2, 4, 6, 8, 12 and 16

• Percent Improvement From Baseline in PASI Score

  Week 0 (Baseline), 2, 4, 6, 8, 12 and 16

• Percentage of Participants Who Achieve Investigator's Global Assessment (IGA) Score Responses of 0, 1 or 2; 0 or 1; and 0

  Week 0, 2, 4, 6, 8, 12 and 16

• Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom and Sign Score at Week 12

  Baseline and Week 12

Study Arms (4)

JNJ-38518168 60 mg

EXPERIMENTAL

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.

Drug: JNJ-38518168 60 mg; Drug: Placebo

JNJ-38518168 30 mg

EXPERIMENTAL

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.

Drug: JNJ-38518168 30 mg; Drug: Placebo

JNJ-38518168 3 mg

EXPERIMENTAL

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

Drug: JNJ-38518168 3 mg; Drug: Placebo

Placebo

EXPERIMENTAL

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.

Drug: Placebo

Interventions

JNJ-38518168 60 mg DRUG

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

Also known as: Toreforant

JNJ-38518168 60 mg

JNJ-38518168 30 mg DRUG

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

Also known as: Toreforant

JNJ-38518168 30 mg

JNJ-38518168 3 mg DRUG

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

Also known as: Toreforant

JNJ-38518168 3 mg

Placebo DRUG

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

JNJ-38518168 3 mg; JNJ-38518168 30 mg; JNJ-38518168 60 mg; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Plainfield, Indiana, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Johnston, Rhode Island, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Spokane, Washington, United States

Location

Unknown Facility

Bydgoszcz, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Warsaw, Poland

Location

MeSH Terms

Conditions

Psoriasis

Interventions

toreforant

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: November 20, 2014
• Study Start: November 17, 2014
• Primary Completion: March 11, 2016
• Study Completion: March 11, 2016
• Last Updated: July 7, 2017

Record last verified: 2017-07

Locations

US (10); PL (3)