Status:
COMPLETED
A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Palmoplantaris Pustulosis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01845987
Start Date
June 1 2013
End Date
September 1 2014
Last Update
November 20 2015
Active Locations (8)
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1
Asahikawa, Japan
2
Fukuoka, Japan
3
Fukushima, Japan
4
Matsumoto, Japan