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

NCT ID: NCT01845987

Last Updated: 2015-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-09-30

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.

Conditions

Palmoplantaris Pustulosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

CNTO 1959

Group Type: EXPERIMENTAL

CNTO 1959

Intervention Type: DRUG

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

Interventions

Placebo

Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4

Intervention Type: DRUG

CNTO 1959

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutical K.K.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutical K.K., Japan Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutical K.K.

Locations

Asahikawa, , Japan

Fukuoka, , Japan

Fukushima, , Japan

Matsumoto, , Japan

Sapporo, , Japan

Sendai, , Japan

Tokyo, , Japan

Touon, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 29417135 (View on PubMed)

Other Identifiers

CNTO1959PPP2001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100950

Identifier Type: -

Identifier Source: org_study_id