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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 2

Conditions

Palmoplantaris Pustulosis

Treatments

Drug: Placebo

Drug: CNTO 1959

Study type

Interventional

Funder types

Industry

Identifiers

NCT01845987

CR100950

CNTO1959PPP2001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, safety, and tolerability of CNTO 1959 following subcutaneous administration in participants with palmoplantar pustulosis.

Full 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.

Enrollment

49 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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