NCT01845987

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 20, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

April 30, 2013

Last Update Submit

October 26, 2015

Conditions

Palmoplantaris Pustulosis

Keywords

Palmoplantaris PustulosisCNTO 1959PsoriasisAnti-IL 23 Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in PPSI total score at 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.

    Baseline to Week 16

Secondary Outcomes (11)

  • Change from baseline in PPSI total score over time

    Baseline up to 24 weeks

  • Change from baseline in PPPASI total score

    Baseline up to 24 weeks

  • Proportion of participants who achieve a PPPASI-50

    Up to 24 weeks

  • Proportion of participants who achieve a PGA score of 1 or less

    Up to 24 weeks

  • Proportion of participants who achieve a PPPASI-75

    Up to 24 weeks

  • +6 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

CNTO 1959

EXPERIMENTAL
Drug: CNTO 1959

Interventions

PlaceboDRUG

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

Placebo
CNTO 1959DRUG

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

CNTO 1959

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Asahikawa, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Fukushima, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Touon, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29417135DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2013

First Posted

May 3, 2013

Study Start

June 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 20, 2015

Record last verified: 2015-10

Locations

JP(8)