NCT01845987CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 49
- Primary Endpoint
- Change from baseline in PPSI total score at Week 16.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
CNTO 1959
Experimental
Intervention: CNTO 1959 (Drug)
Outcomes
Primary Outcomes
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
- Change from baseline in PPPASI total score(Baseline up to 24 weeks)
- Change from baseline in Patient's VAS-PPP severity(Baseline up to 24 weeks)
- Change from baseline in Patient's VAS-PAO activity and pain(Baseline up to 24 weeks)
- Proportion of participants who achieve a PGA score of 1 or less(Up to 24 weeks)
- Change from baseline in Dermatology Life Quality Index (DLQI)(Baseline up to 24 weeks)
- Proportion of participants who achieve a PPPASI-50(Up to 24 weeks)
- Proportion of participants who achieve a PPPASI-75(Up to 24 weeks)
- Change from baseline in PA (each score)(Baseline up to 24 weeks)
- Change from baseline in PPSI total score over time(Baseline up to 24 weeks)
- Change from baseline in Physician's VAS-PAO activity(Baseline up to 24 weeks)
- Change form baseline in SF-36 score(Baseline up to 24 weeks)
Investigators
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