NCT02641730

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of guselkumab for the treatment of participants with palmoplantar pustulosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Typical duration for phase_3

Geographic Reach
1 country

32 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

December 14, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

December 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 17, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 21, 2019

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

December 14, 2015

Results QC Date

August 22, 2018

Last Update Submit

January 31, 2025

Conditions

Palmoplantar Pustulosis

Keywords

GuselkumabCNTO 1959PlaceboPalmoplantar Pustulosis

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Palmoplantar Pustulosis Area and Severity Index (PPPASI) Total Score at Week 16

    PPPASI assesses severity of palmoplantar pustulosis (PPP) lesions and response to therapy. In PPPASI, palms, soles are divided into 4 regions: right palm(RP), left palm(LP), right sole(RS), left sole(LS), that account for 20 percent (%), 20%,30%,30%, respectively, of total surface area(TSA) of palms, soles. Each area is assessed separately for erythema(E), pustules/vesicles (P), desquamation/scales (D), each rated on a scale (0-4). PPPASI produces score range of 0-72 using formula, PPPASI=(E+P+D)Area\*0.2(RP)+(E+P+D)Area\*0.2 (LP)+(E+P+D)Area\*0.3(RS)+(E+P+D)Area\*0.3(LS). Higher a score more the severe disease. Participants who discontinue study agent as they met treatment failure(TF) criterion(lack of efficacy/AE of worsening of PPP/who started a protocol-prohibited medication/therapy that could improve PPP), their baseline value carried forward to post baseline attending visits before and at Week 16 and after TF were applied, remaining missing data were handled with LOCF till Week 60.

    Baseline and Week 16

Secondary Outcomes (19)

  • Change From Baseline in Palmoplantar Severity Index (PPSI) Total Score at Week 16

    Baseline and Week 16

  • Percentage of Participants Who Achieved a PPPASI-50 Response at Week 16

    Week 16

  • Change From Baseline in PPPASI Total Score

    Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84

  • Change From Baseline in PPSI Total Score

    Baseline, Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84

  • Percentage of Participants Who Achieved a PPPASI-50 Response

    Week 2, 4, 8, 12, 20, 24, 28, 32, 36, 40, 44, 48, 52, 60, 72 and Week 84

  • +14 more secondary outcomes

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive guselkumab 200 milligram (mg) at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, and two syringes of placebo at Week 16 to maintain the blind.

Drug: GuselkumabDrug: Placebo

Group 2

EXPERIMENTAL

Participants will receive a syringe of guselkumab 100 mg and a syringe of placebo for guselkumab at Week 0, 4, 12 and every 8 weeks thereafter through Week 60, two syringes of placebo at Week 16 to maintain the blind.

Drug: GuselkumabDrug: Placebo

Group 3

EXPERIMENTAL

Participants will receive two syringes of placebo at Week 0, 4 and 12. At Week 16, placebo participants will be randomized in a 1:1 ratio to guselkumab mg arm (Group 3a) or 100 mg arm (Group 3b). Group 3a participants will receive guselkumab 200 mg at Week 16, 20 and every 8 weeks thereafter through Week 60. Group 3b participants will receive guselkumab 100 mg and a syringe of placebo at Week 16, 20 and every 8 weeks thereafter through Week 60.

Drug: GuselkumabDrug: Placebo

Interventions

GuselkumabDRUG

Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.

Also known as: CNTO 1959
Group 1Group 2Group 3
PlaceboDRUG

Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.

Group 1Group 2Group 3

Eligibility Criteria

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

You may qualify if:

  • Has a diagnosis of palmoplantar pustulosis (with or without pustulotic arthro-osteitis, concurrent extra-palmoplantar lesions) for at least 24 weeks before screening
  • Has a \>= 12 PPPASI total score at screening and at baseline
  • Has a moderate or more severe pustules/vesicle on the palms or soles (\>= 2 PPPASI severity score) at screening and baseline
  • Has inadequate response to the treatment with topical steroid and/or topical vitamin D3 derivative preparations and/or the phototherapy and/or systemic etretinate prior to or at screening. Inadequate response is defined as a case judged by the investigator
  • Before the first administration of study drug, a woman must be either: Not of childbearing potential: premenarchal; postmenopausal or Of childbearing potential and practicing a highly effective method of birth control

You may not qualify if:

  • Has a diagnosis of plaque-type psoriasis
  • Has obvious improvement during screening (\>= 5 PPPASI total score improvement during the screening)
  • Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
  • Has unstable cardiovascular disease, defined as a recent clinical deterioration (eg, unstable angina, rapid atrial fibrillation) in the last 12 weeks or a cardiac hospitalization within the last 12 weeks before screening
  • Currently has a malignancy or has a history of malignancy within 5 years before screening (with the exception of a nonmelanoma skin cancer that has been adequately treated with no evidence of recurrence for at least 12 weeks before screening or cervical carcinoma in situ that has been treated with no evidence of recurrence for at least 12 weeks before screening)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Unknown Facility

Asahikawa, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Fukushima, Japan

Location

Unknown Facility

Hachiōji, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Ichikawa, Japan

Location

Unknown Facility

Ichinomiya, Japan

Location

Unknown Facility

Kahoku-District, Japan

Location

Unknown Facility

Kanazawa, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kofu, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Morioka, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Ōsaka-sayama, Japan

Location

Unknown Facility

Sagamihara, Japan

Location

Unknown Facility

Saku, Japan

Location

Unknown Facility

Shimotsuke, Japan

Location

Unknown Facility

Suita-shi, Japan

Location

Unknown Facility

Takamatsu, Japan

Location

Unknown Facility

Tokushima, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Toyoake, Japan

Location

Unknown Facility

Tōon, Japan

Location

Unknown Facility

Tsu, Japan

Location

Unknown Facility

Tsukuba, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (1)

  • Terui T, Kobayashi S, Okubo Y, Murakami M, Zheng R, Morishima H, Goto R, Kimura T. Efficacy and Safety of Guselkumab in Japanese Patients With Palmoplantar Pustulosis: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2019 Oct 1;155(10):1153-1161. doi: 10.1001/jamadermatol.2019.1394.

    PMID: 31268476DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Senior Director, Immunology General
Organization
Janssen Pharmaceutical K.K.
ClinicalTrialDisclosure@its.jnj.com
844-434-4210

Study Officials

  • Janssen Pharmaceutical K.K. Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 29, 2015

Study Start

December 15, 2015

Primary Completion

March 28, 2017

Study Completion

July 17, 2018

Last Updated

February 4, 2025

Results First Posted

February 21, 2019

Record last verified: 2025-01

Locations

JP(32)