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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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ClinicalTrials.gov Identifier: NCT01845987
Recruitment Status : Completed
First Posted : May 3, 2013
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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.

Condition or disease Intervention/treatment Phase
Palmoplantaris Pustulosis Drug: Placebo Drug: CNTO 1959 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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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:

  • 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

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): NCT01845987


Locations
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Japan
Asahikawa, Japan
Fukuoka, Japan
Fukushima, Japan
Matsumoto, Japan
Sapporo, Japan
Sendai, Japan
Tokyo, Japan
Touon, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01845987     History of Changes
Other Study ID Numbers: CR100950
CNTO1959PPP2001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: October 2015

Keywords provided by Janssen Pharmaceutical K.K.:
Palmoplantaris Pustulosis
CNTO 1959
Psoriasis
Anti-IL 23 Monoclonal Antibody

Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents