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Trial record 2 of 14 for:    "Pustulosis Palmaris Et Plantaris"

An Efficacy and Safety of Guselkumab in Participants With Palmoplantar Pustulosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641730
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : February 21, 2019
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

Condition or disease Intervention/treatment Phase
Palmoplantar Pustulosis Drug: Guselkumab Drug: Placebo Phase 3

Detailed Description:
This is a phase 3, randomized (study drug assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), multicenter (when more than one hospital works on a medical research study) placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study) study in participants with palmoplantar pustulosis. The study will consist of 3 phases: screening phase (up to 6 weeks), treatment period (week 0 - week 60) and observational period (up to week 84). Participants will be assigned to 1 of 3 treatment groups (200 milligram [mg] guselkumab, 100 mg guselkumab or placebo group) using a stratified block randomization method in a 1:1:1 ratio at Week 0 and Group III (placebo) participants will be allocated in a 1:1 ratio to 1 of 2 treatment groups at Week 16. Participants will primarily be assessed for change from baseline in Palmo-Plantar Pustular Area and Severity Index (PPPASI) total score at Week 16. Safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Palmoplantar Pustulosis
Actual Study Start Date : January 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Group 1
Participants will receive guselkumab 200 milligram (mg) at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, and two syringes of placebo at Week 16 to maintain the blind.
Drug: Guselkumab
Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
Other Name: CNTO 1959

Drug: Placebo
Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.

Experimental: Group 2
Participants will receive a syringe of guselkumab 100 mg and a syringe of placebo for guselkumab at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, two syringes of placebo at Week 16 to maintain the blind.
Drug: Guselkumab
Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
Other Name: CNTO 1959

Drug: Placebo
Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.

Experimental: Group 3
Participants will receive two syringes of placebo at Week 0, 4 and 12. At Week 16, placebo participants will be randomized in a 1:1 ratio to guselkumab mg arm (Group 3a) or 100 mg arm (Group 3b). Group 3a participants will receive guselkumab 200 mg at Week 16, 20 and every 8 weeks thereafter through Week 60. Group 3b participants will receive guselkumab 100 mg and a syringe of placebo at Week 16, 20 and every 8 weeks thereafter through Week 60.
Drug: Guselkumab
Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
Other Name: CNTO 1959

Drug: Placebo
Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.




Primary Outcome Measures :
  1. Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI system, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%, 30%, 30%, respectively, of total surface area (TSA) of palms, soles. Each area is assessed separately for erythema (E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces a score range from 0-72 by using formula, PPPASI=(E+P+D) Area*0.2 (RP)+(E+P+D) Area*0.2 (LP)+(E+P+D) Area*0.3 (RS)+(E+P+D) Area*0.3 (LS). Higher score indicates more severe disease. Participants who discontinue study agent as they met a TF criterion (lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF.


Secondary Outcome Measures :
  1. Change From Baseline in Palmoplanter Severity Index (PPSI) Total Score at Week 16 [ Time Frame: Baseline and Week 16 ]
    PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  2. Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16 [ Time Frame: Week 16 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  3. Change From Baseline in PPPASI Total Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, which account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  4. Change From Baseline in PPSI Total Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    The PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening. The identified site was to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for the most severe skin lesion rated on a scale of 0 to 4. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  5. Percentage of Participants Who Achieved a PPPASI-50 Response [ Time Frame: Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-50 response represents participants who achieved at least a 50% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  6. Percentage of Participants Who Achieved a PPPASI-75 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-75 response represents participants who achieved at least a 75% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  7. Percentage of Participants Who Achieved a PPPASI-90 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-90 response represents participants who achieved at least a 90% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  8. Percentage of Participants Who Achieved a PPPASI-100 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPPASI assesses severity of PPP lesions and their response to therapy. In PPPASI system, palms and soles are divided into 4 regions: right palm, left palm, right sole, and left sole, that account for 20%, 20%, 30%, and 30%, respectively, of TSA of palms and soles. Each of these areas is assessed separately for erythema, pustules/vesicles, and desquamation/scales, each rated on a scale of 0 to 4. PPPASI produces a score range from 0 to 72. Higher score indicates more severe disease. PPPASI-100 response represents participants who achieved at least a 100% improvement from baseline in the PPPASI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  9. Percentage of Participants Who Achieved a PPSI-50 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 50 response represents participants who achieved at least a 50% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  10. Percentage of Participants Who Achieved a PPSI-75 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 75 response represents participants who achieved at least a 75% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  11. Percentage of Participants Who Achieved a PPSI-90 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 90 response represents participants who achieved at least a 90% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  12. Percentage of Participants Who Achieved a PPSI-100 Response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and Week 52 ]
    PPSI assesses the severity of PPP lesions and their response to therapy with a score ranging from 0 to 12. In the PPSI system, the more severely affected location (palms or soles) were to be identified as the evaluation sites at screening that to be assessed at all subsequent visits. Evaluation sites were assessed separately for erythema, pustules/vesicles and desquamation/scale, for most severe skin lesion rated on a scale of 0 to 4. PPSI 100 response represents participants who achieved at least a 100% improvement from baseline in the PPSI score. Participants were analyzed according to the treatment at Week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  13. Percentage of Participants in Each Categories of Physician's Global Assessment (PGA) Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52 ]
    The PGA documents the Physician's Global Assessment of the PPP overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders at week 16 and after TF were applied, remaining missing data were handled with LOCF.

  14. Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52 ]
    The PGA documents the Physician's Global Assessment of the participants's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1) were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders through Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  15. Percentage of Participants Who Achieved a PGA Score of Cleared (0) or Almost Cleared (1) and Had at Least a 2-Grade Improvement [ Time Frame: Week 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and week 52 ]
    The PGA documents the Physician's Global Assessment of the participant's palmoplantar overall skin lesions status. The participant's PPP is assessed as clear (0), almost clear (1), mild (2), moderate (3), severe (4), or very severe (5). Participants who achieved a PGA score of clear (0) or almost clear (1), and had at least a 2-grade improvement from baseline were reported. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion were considered as nonresponders through Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  16. Change From Baseline in the Dermatology Life Quality Index (DLQI) Score [ Time Frame: Baseline, week 16, 32 and week 52 ]
    The DLQI is a dermatology-specific uality of life (QOL) instrument designed to assess the impact of the disease on a participant's QOL. It is a 10-item participant-reported outcome questionnaire that, in addition to evaluating overall QOL, can be used to assess 6 different aspects that may affect QOL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. The DLQI produces a numeric score that can range from 0 to 30. Higher score indicates more severe disease. Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF.

  17. Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Baseline, week 16, 32 and week 52 ]
    SF-36 consists of 8 individual domains, which are weighted sums of the questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary PCS is derived. Scales contributing most to the scoring of the SF-36 PCS include PF,RP,BP and GH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary PCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF.

  18. Change From Baseline in the 36-Item Short-Form Health Assessment Questionnaire (SF-36) Mental Component Summary (MCS) Score [ Time Frame: Baseline, week 16, 32 and week 52 ]
    SF-36 consists of 8 individual domains, which are weighted sums of the questions in their section. 8 domains are: vitality(VT), physical functioning(PF), bodily pain(BP), general health(GH), Role-Physical(RP), Role-Emotional(RE), social functioning(SF) and mental health(MH). Each of these 8 scales (domains) is scored from 0 to 100 with higher scores indicating better health. Based on the scale scores, the summary MCS is derived. Scales contributing most to the scoring of the SF-36 MCS include VT,SF,RE and MH. Other domains not noted contribute to scoring but to a lesser degree. Scoring is derived based on an algorithm as presented in Japanese edition manual. Summary MCS score is also scaled from 0 to 100 with higher scores indicating better health. Participants who discontinue study agent as they met a TF criterion, their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF.

  19. Change From Baseline in the EuroQOL-5 Dimensions Questionnaire Visual Analogue Scale (EQ-5D VAS) Score [ Time Frame: Baseline, week 16, 32 and week 52 ]
    EQ-5D is designed for self-completion by participants and consists of EQ-5D descriptive system and the EQ visual analog scale (EQ VAS). The EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and unable. The EQ VAS records the respondent's self-rated health on a vertical, VAS where the endpoints are labeled 'Best imaginable health state' (score of 100) and 'Worst imaginable health state' (score of 0). Participants were analyzed according to the treatment at week 0 or 16. Participants who discontinue study agent as they met a TF criterion their baseline value carried forward to the post-baseline attending visits before and at week 16 and after TF were applied, remaining missing data were handled with LOCF.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening
  • Has a >= 12 PPPASI total score at screening and at baseline
  • Has a moderate or more severe pustules/vesicle on the palms or soles (>= 2 PPPASI severity score) at screening and baseline
  • Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator
  • Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control

Exclusion Criteria:

  • Has a diagnosis of plaque-type psoriasis
  • Has obvious improvement during screening (>= 5 PPPASI total score improvement during the screening)
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening
  • Currently has a malignancy or has a 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 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641730


Locations
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Japan
Asahikawa, Japan
Fukuoka, Japan
Fukushima, Japan
Hachioji, Japan
Hokkaido, Japan
Ichikawa, Japan
Ichinomiya-City, Japan
Kahoku-District, Japan
Kanazawa, Japan
Kobe, Japan
Kochi, Japan
Kofu, Japan
Kumamoto-City, Japan
Kyoto, Japan
Matsumoto, Japan
Morioka, Japan
Nagasaki, Japan
Nagoya, Japan
Osaka-Sayama, Japan
Osaka, Japan
Sagamihara, Japan
Saku, Japan
Shimotsuke, Japan
Takamatsu, Japan
Tokushima, Japan
Tokyo, Japan
Toon, Japan
Toyoake, Japan
Tsukuba, Japan
Tsu, Japan
Yokohama, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  Study Documents (Full-Text)

Documents provided by Janssen Pharmaceutical K.K.:
Statistical Analysis Plan  [PDF] April 19, 2017
Study Protocol  [PDF] December 15, 2017


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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT02641730     History of Changes
Other Study ID Numbers: CR108046
CNTO1959PPP3001 ( Other Identifier: Janssen Pharmaceutical K.K. )
First Posted: December 29, 2015    Key Record Dates
Results First Posted: February 21, 2019
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Pharmaceutical K.K.:
Guselkumab
CNTO 1959
Placebo
Palmoplantar Pustulosis

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases