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Completed

NCT Number: NCT01845987

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

The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.

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Key information

Conditions

Palmoplantaris Pustulosis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asahikawa, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

CNTO 1959

Drug

CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

Primary outcomes

  1. Change from baseline in PPSI total score at Week 16.

    Time frame: Baseline to 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 outcomes

  1. Change from baseline in PPSI total score over time

    Time frame: Baseline up to 24 weeks

    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.

  2. Change from baseline in PPPASI total score

    Time frame: Baseline up to 24 weeks

    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.

  3. Proportion of participants who achieve a PPPASI-50

    Time frame: Up to 24 weeks

    PPPASI-50 is at least 50% reduction in the PPPASI score.

  4. Proportion of participants who achieve a PGA score of 1 or less

    Time frame: Up to 24 weeks

    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).

  5. Proportion of participants who achieve a PPPASI-75

    Time frame: Up to 24 weeks

    PPPASI-75 is at least 75% reduction in the PPPASI score.

  6. Change from baseline in PA (each score)

    Time frame: Baseline up to 24 weeks

    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).

  7. Change from baseline in Patient's VAS-PPP severity

    Time frame: Baseline up to 24 weeks

    The Patient's Visual Analogue Scale (VAS) assessment of palmoplantar pustulosis severity will be recorded on a 10-cm VAS.

  8. Change from baseline in Physician's VAS-PAO activity

    Time frame: Baseline up to 24 weeks

    Physician's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity will be recorded on a 10-cm VAS.

  9. Change from baseline in Patient's VAS-PAO activity and pain

    Time frame: Baseline up to 24 weeks

    Patient's Visual Analogue Scale Assessment of Pustulotic Arthro-Osteitis Activity and Pain will be recorded on each 10-cm VAS.

  10. Change from baseline in Dermatology Life Quality Index (DLQI)

    Time frame: Baseline up to 24 weeks

    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.

  11. Change form baseline in SF-36 score

    Time frame: Baseline up to 24 weeks

    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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 3, 2013
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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