xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039189</url>
    </required_header>
    <id_info>
      <org_study_id>CR109328</org_study_id>
      <secondary_id>CNTO1959PSO3017</secondary_id>
      <nct_id>NCT06039189</nct_id>
    </id_info>
    <brief_title>Study of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area Moderate Plaque Psoriasis</brief_title>
    <acronym>SPECTREM</acronym>
    <official_title>A Phase 3b, Multicenter, Randomized, Double-blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Guselkumab Versus Placebo for the Treatment of Low Body Surface Area (BSA) Moderate Plaque Psoriasis With Special Site Involvement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Janssen Research &amp; Development, LLC</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Janssen Research &amp; Development, LLC</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive&#xD;
        drug in participants with low body surface area moderate plaque psoriasis and special site&#xD;
        involvement.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">May 26, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 28, 2025</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16</measure>
      <time_frame>Baseline, Week 16</time_frame>
      <description>Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16</measure>
      <time_frame>Baseline, Week 16</time_frame>
      <description>Change from baseline in PASI score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve a PASI 90 Response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve a PASI 90 response at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (&gt;=) 90 percent (%) improvement in PASI score from baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve a PASI 100 Response at Week 16</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve a PASI 100 response at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score &gt;=3 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score &gt;=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score &gt;=3 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score &gt;=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score &gt;=3 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score &gt;=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score &gt;=3 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score &gt;=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16</measure>
      <time_frame>Baseline, Week 16</time_frame>
      <description>Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants who Achieve &gt;=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score &gt;=4 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants who achieve &gt;=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score &gt;=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD &gt;0 at Baseline</measure>
      <time_frame>Week 16</time_frame>
      <description>Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD &gt;0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Adverse Events (AEs)</measure>
      <time_frame>Up to Week 56</time_frame>
      <description>Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
      <time_frame>Up to Week 56</time_frame>
      <description>Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Moderate Plaque Psoriasis</condition>
    <arm_group>
      <arm_group_label>Group 1: Guselkumab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Guselkumab</intervention_name>
      <description>Guselkumab will be administered as subcutaneous injection.</description>
      <arm_group_label>Group 1: Guselkumab</arm_group_label>
      <arm_group_label>Group 2: Placebo</arm_group_label>
      <other_name>CNTO1959</other_name>
      <other_name>Tremfya</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo will be administered as subcutaneous injection.</description>
      <arm_group_label>Group 1: Guselkumab</arm_group_label>
      <arm_group_label>Group 2: Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All participants must have a diagnosis of plaque psoriasis (with or without psoriatic&#xD;
               arthritis) for at least 6 months before first administration of study intervention&#xD;
  &#xD;
            -  All participants must meet the following disease severity criteria at screening and at&#xD;
               baseline: (a) Overall Investigator's Global Assessment (IGA) 3 (moderate) plaque&#xD;
               psoriasis; (b) Body Surface Area (BSA) 2-15 percent (%) with at least 1 plaque outside&#xD;
               of special sites; (c) Involvement of at least 1 special site with at least moderate&#xD;
               severity. Qualifying sites include scalp with scalp-specific IGA greater than or equal&#xD;
               to (&gt;=) 3, face with facial psoriasis IGA &gt;=3, intertriginous with intertriginous&#xD;
               psoriasis IGA &gt;=3, or genital with static physician global assessment of genitalia&#xD;
               (sPGA-G) &gt;=3&#xD;
  &#xD;
            -  All participants be inadequately controlled with or intolerant of at least 1 prior&#xD;
               topical therapy (including, but not limited to, corticosteroids, retinoids, vitamin D,&#xD;
               or vitamin D/steroid and retinoid/steroid combinations, tacrolimus, pimecrolimus,&#xD;
               anthralin/dithranol, coal tar preparations, tapinarof, roflumilast, etcetera) for the&#xD;
               treatment of psoriasis at both screening&#xD;
  &#xD;
            -  All participants be a candidate for phototherapy or systemic treatment for psoriasis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has a nonplaque form of psoriasis (example, erythrodermic, guttate, or pustular) at&#xD;
               screening or randomization&#xD;
  &#xD;
            -  Has current drug-induced psoriasis (for example, a new onset of psoriasis or an&#xD;
               exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)&#xD;
  &#xD;
            -  For participants with palmoplantar involvement, confounding diagnoses, including, but&#xD;
               not limited, to palmoplantar pustulosis, eczematous dermatitis, contact/irritant&#xD;
               dermatitis, acquired keratoderma, etcetera, should be confirmed and excluded&#xD;
  &#xD;
            -  Participants will not be eligible if they have ever received prior biologic (or&#xD;
               biosimilars of) for the treatment of psoriasis, psoriatic arthritis (PsA), or any&#xD;
               other indications that could impact the assessment of psoriasis. Prior biologics (or&#xD;
               biosimilars of) may include, but not limited to, tumor necrosis factor&#xD;
               (TNF)-inhibitors (for example: adalimumab, etanercept, infliximab, or certolizumab or&#xD;
               biosimilars), interleukin (IL)-17 inhibitors (for example: secukinumab, ixekizumab,&#xD;
               brodalumab, or bimekizumab), and IL-12/23 inhibitors (for example: ustekinumab), or&#xD;
               IL-23 inhibitor (for example: guselkumab, risankizumab or tildrakizumab)&#xD;
  &#xD;
            -  Has a history of chronic or recurrent infectious disease, including, but not limited&#xD;
               to, chronic renal infection, chronic chest infection (for example, bronchiectasis),&#xD;
               recurrent urinary tract infection (recurrent pyelonephritis or chronic non-remitting&#xD;
               cystitis), fungal infection (mucocutaneous candidiasis), or open, draining, or&#xD;
               infected skin wounds or ulcers&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Janssen Research &amp; Development, LLC</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>844-434-4210</phone>
      <email>Participate-In-This-Study@its.jnj.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Miami VA Healthcare System</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33125</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Center for Clinical Studies</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Suzanne Bruce and Associates - The Center for Skin Research</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77056-4132</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Progressive Clinical Research</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Psoriasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data sharing policy of the Janssen Pharmaceutical Companies of Johnson &amp; Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu</ipd_description>
      <ipd_url>https://www.janssen.com/clinical-trials/transparency</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039189
  org study id: CR109328
  secondary id: CNTO1959PSO3017
  nct id: NCT06039189
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this study is to evaluate the efficacy of guselkumab compared to an inactive
        drug in participants with low body surface area moderate plaque psoriasis and special site
        involvement.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) at Week 16
  time frame: Week 16
  description: Percentage of participants who achieve an IGA score of cleared (0) or minimal (1) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  measure: Change From Baseline in Body Surface Area (BSA) Affected With Psoriasis at Week 16
  time frame: Baseline, Week 16
  description: Change from baseline in BSA affected with psoriasis at Week 16 will be reported. The BSA is a measurement of involved skin over the whole body. The overall BSA affected by psoriasis is estimated based on the participant's handprint (defined as the entire palmar surface of the hand including fingers).
  measure: Change From Baseline in Total Psoriasis Area and Severity Index (PASI) Score at Week 16
  time frame: Baseline, Week 16
  description: Change from baseline in PASI score at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease.
  measure: Percentage of Participants who Achieve an Investigator's Global Assessment (IGA) Score of Cleared (0) at Week 16
  time frame: Week 16
  description: Percentage of participants who achieve an IGA score of cleared (0) at Week 16 will be reported. The IGA documents the investigator's assessment of the participant's psoriasis. Overall lesions are graded for induration, erythema, and scaling. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
  measure: Percentage of Participants who Achieve a PASI 90 Response at Week 16
  time frame: Week 16
  description: Percentage of participants who achieve a PASI 90 response at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response is defined as greater than or equal to (>=) 90 percent (%) improvement in PASI score from baseline.
  measure: Percentage of Participants who Achieve a PASI 100 Response at Week 16
  time frame: Week 16
  description: Percentage of participants who achieve a PASI 100 response at Week 16 will be reported. The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for erythema, induration and scaling, which are each rated on a scale of 0 to 4 that is none to maximum severity. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response is defined as 100% improvement in PASI score from baseline.
  measure: Percentage of Participants who Achieve a Scalp-Specific Investigator Global Assessment (ss-IGA) Score of Absence of Disease (0) or Very Mild Disease (1) at Week 16 Among Participants With an ss-IGA Score >=3 at Baseline
  time frame: Week 16
  description: Percentage of participants who achieve a ss-IGA score of absence of disease (0) or very mild disease (1) at Week 16 among participants with an ss-IGA score >=3 at baseline will be reported. The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. Scalp lesions are graded for induration, erythema, and scaling. The participant's scalp psoriasis is assessed as absence of disease (0), very mild disease (1), mild disease (2), moderate disease (3), or severe disease (4).
  measure: Percentage of Participants who Achieve a Static Physician's Global Assessment of Genitalia (sPGA-G) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With a sPGA-G Score >=3 at Baseline
  time frame: Week 16
  description: Percentage of participants who achieve a sPGA-G score of clear (0) or minimal (1) at Week 16 among participants with a sPGA-G score >=3 at baseline will be reported. The sPGA-G is used to evaluate the disease severity of genital psoriasis. Severity of genital psoriasis is determined by a combination of 3 plaque characteristics: erythema, elevation, and scale. The participant's severity of genital psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), and very severe (5).
  measure: Percentage of Participants who Achieve an Intertriginous IGA (i-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an i-IGA Score >=3 at Baseline
  time frame: Week 16
  description: Percentage of participants who achieve an i-IGA score of clear (0) or minimal (1) at Week 16 among participants with an i-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment has been adapted with descriptions of disease features that are more consistent with intertriginous psoriasis presentation. The intertriginous areas affected to be scored include the axillary, sub-mammary, abdominal fold, inguinal, and intergluteal cleft/peri-anal region (distinct from genital/perineum involvement). The participant's intertriginous areas affected are assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
  measure: Percentage of Participants who Achieve a Facial IGA (f-IGA) Score of Clear (0) or Minimal (1) at Week 16 Among Participants With an f-IGA Score >=3 at Baseline
  time frame: Week 16
  description: Percentage of participants who achieve a f-IGA score of clear (0) or minimal (1) at Week 16 among participants with an f-IGA score >=3 at baseline will be reported. The IGA used for the full body assessment will be adapted for use, but only the face will be scored. The participant's facial psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), and severe (4).
  measure: Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Total Symptom Score at Week 16
  time frame: Baseline, Week 16
  description: Change from baseline in PSSD total symptom score at Week 16 will be reported. The PSSD includes patient-reported outcome (PRO) questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  measure: Percentage of Participants who Achieve >=4 Point Reduction (Improvement) in PSSD Itch Score From Baseline at Week 16 Among Participants With a PSSD Itch Score >=4 at Baseline
  time frame: Week 16
  description: Percentage of participants who achieve >=4 point reduction (improvement) in PSSD itch score from baseline at Week 16 among participants with a PSSD itch score >=4 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  measure: Percentage of Participants With PSSD Individual Symptom Scale Score of 0 at Week 16 Among Participants With PSSD >0 at Baseline
  time frame: Week 16
  description: Percentage of participants with PSSD individual symptom score of 0 at Week 16 among participants with PSSD >0 at baseline will be reported. The PSSD includes PRO questionnaire designed to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. The PSSD is a patient-reported outcome instrument that includes 11 items covering symptoms (itch, pain, stinging, burning and skin tightness) and participant observable signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) using 0 to 10 numerical rating scales for severity. Two sub scores are derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.
  measure: Number of Participants With Adverse Events (AEs)
  time frame: Up to Week 56
  description: Number of participants with AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
  measure: Number of Participants With Serious Adverse Events (SAEs)
  time frame: Up to Week 56
  description: Number of participants with SAEs will be reported. A SAE is any untoward medical occurrence that may results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
  arm group label: Group 1: Guselkumab
  arm group type: Experimental
  description: Participants will receive guselkumab by subcutaneous injection with placebo as needed to maintain the blind.
  arm group label: Group 2: Placebo
  arm group type: Placebo Comparator
  description: Participants will receive placebo by subcutaneous injection then receive guselkumab by subcutaneous injection.
  intervention type: Drug
  intervention name: Guselkumab
  description: Guselkumab will be administered as subcutaneous injection.
  arm group label: Group 1: Guselkumab
  arm group label: Group 2: Placebo
  other name: CNTO1959
  other name: Tremfya
  intervention type: Drug
  intervention name: Placebo
  description: Placebo will be administered as subcutaneous injection.
  arm group label: Group 1: Guselkumab
  arm group label: Group 2: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Janssen Research & Development, LLC Clinical Trial
  role: Study Director
  affiliation: Janssen Research & Development, LLC
  last name: Study Contact
  phone: 844-434-4210
  email: Participate-In-This-Study@its.jnj.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Psoriasis
  sharing ipd: Yes
  ipd description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
  ipd url: https://www.janssen.com/clinical-trials/transparency