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

Palmoplantaris Pustulosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845987
• Other study ID #: CR100950
• Secondary ID: CNTO1959PPP2001
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2013
• Last updated: October 26, 2015
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review BoardJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Palmoplantaris Pustulosis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to Week 16	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	Proportion of participants who achieve a PPPASI-50	PPPASI-50 is at least 50% reduction in the PPPASI score.	Up to 24 weeks	No
Secondary	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).	Up to 24 weeks	No
Secondary	Proportion of participants who achieve a PPPASI-75	PPPASI-75 is at least 75% reduction in the PPPASI score.	Up to 24 weeks	No
Secondary	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).	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No
Secondary	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.	Baseline up to 24 weeks	No