A Phase 2 interventional study of JNJ-38518168 60 mg and JNJ-38518168 30 mg in Psoriasis, sponsored by Janssen Research & Development, LLC. Completed at 14 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-07.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
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Exclusion Criteria:
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
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
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
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
Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily.
Also known as: Toreforant
One tablet of JNJ-38518168, 30 mg, orally, once daily.
Also known as: Toreforant
One tablet of JNJ-38518168, 3 mg, orally, once daily.
Also known as: Toreforant
Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.
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.
Time frame: Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 12
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Janssen Research & Development, LLC