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A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis

Primary Purpose

Palmoplantaris Pustulosis

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Placebo
CNTO 1959
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmoplantaris Pustulosis focused on measuring Palmoplantaris Pustulosis, CNTO 1959, Psoriasis, Anti-IL 23 Monoclonal Antibody

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included)
  • Participant has active lesions on the palms or soles at screening and baseline
  • Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening
  • Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline
  • At screening, the results of laboratory blood tests must be within protocol-specified limits

Exclusion Criteria:

  • History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease
  • Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening
  • History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
  • Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening
  • Participant has or has had herpes zoster within the 2 months prior to screening

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

CNTO 1959

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in PPSI total score at Week 16.
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.

Secondary Outcome Measures

Change from baseline in PPSI total score over time
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Change from baseline in PPPASI total score
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 72, with higher scores indicating more severity.
Proportion of participants who achieve a PPPASI-50
PPPASI-50 is at least 50% reduction in the PPPASI score.
Proportion of participants who achieve a PGA score of 1 or less
The Physician's Global Assessment (PGA) is used to determine the participant's overall palmoplantar pustulosis lesions, at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Proportion of participants who achieve a PPPASI-75
PPPASI-75 is at least 75% reduction in the PPPASI score.
Change from baseline in PA (each score)
The Physician's Assessment (PA) is used to determine the participant's pustule, vesicle, and nail lesions at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Change from baseline in Patient's VAS-PPP severity
The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.
Change from baseline in Physician's VAS-PAO activity
Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.
Change from baseline in Patient's VAS-PAO activity and pain
Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.
Change from baseline in Dermatology Life Quality Index (DLQI)
The DLQI is a 10-item questionnaire that in addition to evaluating overall quality of life (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.
Change form baseline in SF-36 score
The 36-Item Short Form Health Survey (SF-36) consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception.

Full Information

First Posted
April 30, 2013
Last Updated
October 26, 2015
Sponsor
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT01845987
Brief Title
A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody, Following Subcutaneous Administration in Subjects With Palmoplantar Pustulosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.
Detailed Description
This will be a double-blind (participants and study personnel will not know the identity of the treatments given), multicenter study that is placebo-controlled (a placebo is identical to a study treatment, but has no active ingredients). Participants will be randomly assigned to 1 of 2 treatment groups (CNTO 1959 or placebo). The total duration of participation will be approximately 30 weeks, including a screening period of about 6 weeks before dosing. Participant safety will be monitored throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palmoplantaris Pustulosis
Keywords
Palmoplantaris Pustulosis, CNTO 1959, Psoriasis, Anti-IL 23 Monoclonal Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
CNTO 1959
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
Intervention Type
Drug
Intervention Name(s)
CNTO 1959
Intervention Description
CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
Primary Outcome Measure Information:
Title
Change from baseline in PPSI total score at Week 16.
Description
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change from baseline in PPSI total score over time
Description
The Palmoplantar Pustulosis Severity Index (PPSI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 12, with higher scores indicating more severity.
Time Frame
Baseline up to 24 weeks
Title
Change from baseline in PPPASI total score
Description
The Palmoplantar Pustulosis Area and Severity Index (PPPASI) assesses the severity of palmoplantar pustulosis lesions and their response to therapy. Scores can range from 0 to 72, with higher scores indicating more severity.
Time Frame
Baseline up to 24 weeks
Title
Proportion of participants who achieve a PPPASI-50
Description
PPPASI-50 is at least 50% reduction in the PPPASI score.
Time Frame
Up to 24 weeks
Title
Proportion of participants who achieve a PGA score of 1 or less
Description
The Physician's Global Assessment (PGA) is used to determine the participant's overall palmoplantar pustulosis lesions, at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Time Frame
Up to 24 weeks
Title
Proportion of participants who achieve a PPPASI-75
Description
PPPASI-75 is at least 75% reduction in the PPPASI score.
Time Frame
Up to 24 weeks
Title
Change from baseline in PA (each score)
Description
The Physician's Assessment (PA) is used to determine the participant's pustule, vesicle, and nail lesions at a given time point. Scores can range from 0 (clear) to 5 (very severe).
Time Frame
Baseline up to 24 weeks
Title
Change from baseline in Patient's VAS-PPP severity
Description
The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.
Time Frame
Baseline up to 24 weeks
Title
Change from baseline in Physician's VAS-PAO activity
Description
Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.
Time Frame
Baseline up to 24 weeks
Title
Change from baseline in Patient's VAS-PAO activity and pain
Description
Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.
Time Frame
Baseline up to 24 weeks
Title
Change from baseline in Dermatology Life Quality Index (DLQI)
Description
The DLQI is a 10-item questionnaire that in addition to evaluating overall quality of life (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.
Time Frame
Baseline up to 24 weeks
Title
Change form baseline in SF-36 score
Description
The 36-Item Short Form Health Survey (SF-36) consists of 8 multi-item scales: limitations in physical functioning due to health problems, limitations in usual role activities due to physical health problems, bodily pain, general mental health (psychological distress and well-being), limitations in usual role activities due to personal or emotional problems, limitations in social functioning due to physical or mental health problems, vitality (energy and fatigue), and general health perception.
Time Frame
Baseline up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant has a diagnosis of palmoplantar pustulosis at screening (participants with concurrent extra-palmoplantar lesions [includes plaque-type psoriasis lesions] and/or pustulotic arthro-osteitis [PAO] can also be included) Participant has active lesions on the palms or soles at screening and baseline Participant has inadequate response to treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or phototherapy and/or systemic etretinate prior to or at screening Participant has a Palmoplantar Pustulosis Severity Index (PPSI) score of 7 or greater at screening and baseline At screening, the results of laboratory blood tests must be within protocol-specified limits Exclusion Criteria: History of or current signs of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurologic, cerebral, or psychiatric disease Participant has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months or a cardiac hospitalization within the last 3 months prior to screening History of chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), recurrent urinary tract infection (eg, recurrent pyelonephritis), fungal infection (eg, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers Participant has or has had a serious infection (eg, sepsis, pneumonia or pyelonephritis), or has been hospitalized or received intravenous (IV) antibiotics for an infection during the 2 months prior to screening Participant has or has had herpes zoster within the 2 months prior to screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Asahikawa
Country
Japan
City
Fukuoka
Country
Japan
City
Fukushima
Country
Japan
City
Matsumoto
Country
Japan
City
Sapporo
Country
Japan
City
Sendai
Country
Japan
City
Tokyo
Country
Japan
City
Touon
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29417135
Citation
Terui T, Kobayashi S, Okubo Y, Murakami M, Hirose K, Kubo H. Efficacy and Safety of Guselkumab, an Anti-interleukin 23 Monoclonal Antibody, for Palmoplantar Pustulosis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):309-316. doi: 10.1001/jamadermatol.2017.5937.
Results Reference
derived

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A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis

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