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| ID | Type | Description | Link |
|---|---|---|---|
| 38518168PSO2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2015-000277-12 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-38518168 60 mg | Drug | Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve a Score of 0 or 1 on the Investigator's Global Assessment (IGA) at Week 12 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling on a scale of 0 to 4 (higher score = more severe). The participant's psoriasis is assessed as 5-point scale as follows: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=severe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | United States | ||||
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| JNJ-38518168 30 mg | Drug | One tablet of JNJ-38518168, 30 mg, orally, once daily. |
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| JNJ-38518168 3 mg | Drug | One tablet of JNJ-38518168, 3 mg, orally, once daily. |
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| Placebo | Drug | Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally. |
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| Week 12 |
| Percentage of Participants Who Achieve PASI 50, PASI 75, PASI 90 and PASI 100 Responses | 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, % area of skin involved was estimated:0=0%, 1= <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 50, 75, 90, 100 response is defined as corresponding >= 50%, >=75%, >=90%, >=100% improvement in PASI score from baseline. | Week 0, 2, 4, 6, 8, 12 and 16 |
| Percent Improvement From Baseline in PASI Score | 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, % area of skin involved was estimated:0=0%, 1= <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. | 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 | The IGA documents the investigator's assessment of the participants psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling on a scale of 0 to 4 (higher score = more severe). The participant's psoriasis is assessed as 5-point scale as follows: 0=cleared, 1=minimal, 2=mild, 3=moderate, 4=severe. | 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 | The PSSD is a questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered patient-reported outcome (PRO) instrument that includes 11 items covering symptoms and patient-observable signs. The psoriasis symptom score includes itch (Q1), pain (Q11), stinging (Q10), burning (Q9) and skin tightness (Q4) and average value of all 5 items will be converted into 0-100 score, where 0= least severe to 100=most severe. The psoriasis sign score includes skin dryness (Q2), cracking (Q3), scaling (Q5), shedding or flaking (Q6), redness (Q7) and bleeding (Q8) and average value of all 6 items will be converted into 0-100 score, where 0= least severe to 100=most severe. Total score includes all 11 individual items (both symptom and signs) and average value of all 11 items will be converted into 0-100 score, where 0= least severe to 100=most severe. | Baseline and Week 12 |
| Percentage of Participants Who Achieve a PSSD Symptom Score of 0 or PSSD Sign Score of 0 at Week 12 | The PSSD is a questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms and patient-observable signs. The psoriasis symptom score includes itch (Q1), pain (Q11), stinging (Q10), burning (Q9) and skin tightness (Q4) and average value of all 5 items will be converted into 0-100 score, where 0= least severe to 100=most severe. The psoriasis sign score includes skin dryness (Q2), cracking (Q3), scaling (Q5), shedding or flaking (Q6), redness (Q7) and bleeding (Q8) and average value of all 6 items will be converted into 0-100 score, where 0= least severe to 100=most severe. Total score includes all 11 individual items (both symptom and signs) and average value of all 11 items will be converted into 0-100 score, where 0= least severe to 100=most severe. | Week 12 |
| Percentage of Participants who Achieve PSSD Individual (Psoriasis Symptom Score and Psoriasis Sign Score) Sub-Scale Score of 0 at Week 12 | The PSSD is a questionnaire designed to measure the severity of psoriasis symptoms and signs over the previous 7 days for the assessment of treatment benefit. The PSSD is a self-administered PRO instrument that includes 11 items covering symptoms and patient-observable signs. The psoriasis symptom score includes itch (Q1), pain (Q11), stinging (Q10), burning (Q9) and skin tightness (Q4) and average value of all 5 items will be converted into 0-100 score, where 0= least severe to 100=most severe. The psoriasis sign score includes skin dryness (Q2), cracking (Q3), scaling (Q5), shedding or flaking (Q6), redness (Q7) and bleeding (Q8) and average value of all 6 items will be converted into 0-100 score, where 0= least severe to 100=most severe. Total score includes all 11 individual items (both symptom and signs) and average value of all 11 items will be converted into 0-100 score, where 0= least severe to 100=most severe. | Week 12 |
| 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 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000633524 | toreforant |
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