Clinical trial NCT01845987: A Study of the Efficacy, Safety and Tolerability of CNTO 1959, a Human Anti-IL 23 Monoclonal Antibody in Participants With Palmoplantar Pustulosis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Palmoplantaris Pustulosis
Keywords: Palmoplantaris Pustulosis
CNTO 1959
Psoriasis
Anti-IL 23 Monoclonal Antibody
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in PPSI total score at Week 16.
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change from baseline in PPSI total score over time
timeFrame: Baseline up to 24 weeks
measure: Change from baseline in PPPASI total score
timeFrame: Baseline up to 24 weeks
measure: Proportion of participants who achieve a PPPASI-50
timeFrame: Up to 24 weeks
measure: Proportion of participants who achieve a PGA score of 1 or less
timeFrame: Up to 24 weeks
measure: Proportion of participants who achieve a PPPASI-75
timeFrame: Up to 24 weeks
measure: Change from baseline in PA (each score)
timeFrame: Baseline up to 24 weeks
measure: Change from baseline in Patient's VAS-PPP severity
timeFrame: Baseline up to 24 weeks
measure: Change from baseline in Physician's VAS-PAO activity
timeFrame: Baseline up to 24 weeks
measure: Change from baseline in Patient's VAS-PAO activity and pain
timeFrame: Baseline up to 24 weeks
measure: Change from baseline in Dermatology Life Quality Index (DLQI)
timeFrame: Baseline up to 24 weeks
measure: Change form baseline in SF-36 score
timeFrame: Baseline up to 24 weeks
Other outcomes:
Locations:
city: Asahikawa
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Matsumoto
country: Japan
city: Sapporo
country: Japan
city: Sendai
country: Japan
city: Tokyo
country: Japan
city: Touon
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Terui T, Kobayashi S, Okubo Y, Murakami M, Hirose K, Kubo H. Efficacy and Safety of Guselkumab, an Anti-interleukin 23 Monoclonal Antibody, for Palmoplantar Pustulosis: A Randomized Clinical Trial. JAMA Dermatol. 2018 Mar 1;154(3):309-316. doi: 10.1001/jamadermatol.2017.5937.