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PsoriasisPhase 2NCT02295865

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

A Phase 2 study testing JNJ-38518168 60 mg, JNJ-38518168 30 mg and JNJ-38518168 3 mg in people with Psoriasis, run by Janssen Research & Development, LLC at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriasis
What is being tested?
JNJ-38518168 60 mg, JNJ-38518168 30 mg and JNJ-38518168 3 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
13 sitesin 2 countries
Study dates
17 Nov 2014to 11 Mar 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

United States10 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Indianapolis, Indiana

  • Study site

    Johnston, Rhode Island

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Plainfield, Indiana

  • Study site

    Portland, Oregon

  • Study site

    San Antonio, Texas

  • Study site

    Santa Monica, California

  • Study site

    Spokane, Washington

Other trials in United States

Poland3 sites

  • Study site

    Bydgoszcz

  • Study site

    Lodz

  • Study site

    Warsaw

Other trials in Poland

About this study

Official title: A Phase 2 Multicenter, Randomized, Double-blind, Placebo-Controlled, Trial to Evaluate Toreforant (JNJ-38518168) for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis

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).

Read the 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
Being tested
JNJ-38518168 60 mg, JNJ-38518168 30 mg, JNJ-38518168 3 mg, Placebo
Keywords
Psoriasis, Toreforant, JNJ-38518168
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-38518168 60 mgDrug

    Also called Toreforant

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

  • JNJ-38518168 30 mgDrug

    Also called Toreforant

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

  • JNJ-38518168 3 mgDrug

    Also called Toreforant

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

  • PlaceboDrug

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

Study groups in NCT02295865
Study groupRoleWhat they receive
JNJ-38518168 60 mgExperimentalParticipants 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.
Receives: Drug: JNJ-38518168 60 mg; Drug: Placebo
JNJ-38518168 30 mgExperimentalParticipants 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.
Receives: Drug: JNJ-38518168 30 mg; Drug: Placebo
JNJ-38518168 3 mgExperimentalParticipants will receive one tablet of JNJ-38518168, 3 mg, together with three 30 mg matching placebo tablets, orally, once daily, for 12 Weeks.
Receives: Drug: JNJ-38518168 3 mg; Drug: Placebo
PlaceboExperimentalParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 12

Secondary outcomes (7)

  1. 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.

    Measured: Week 12

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

    Measured: Baseline and Week 12

  6. 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.

    Measured: Week 12

  7. 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study start17 Nov 2014
  3. Primary completion11 Mar 2016
  4. Study completion11 Mar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02295865
Sponsor's protocol ID
CR106239
Other IDs
38518168PSO2001, 2015-000277-12, 2015
Status last verified
Jul 2017
First submitted
18 Nov 2014
Last updated
7 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-38518168 60 mg, JNJ-38518168 30 mg and JNJ-38518168 3 mg in people with Psoriasis, run by Janssen Research & Development, LLC at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve Psoriasis Area and Severity Index (PASI) 75 Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02295865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2017.

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