A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis

NCT03998683 | Completed Phase 3

• 3 other identifiers: CR1086112018-003206-58CNTO1959PSO3013
• Study Type: interventional
• Target: 117
• Locations: 5 countries
• Sites: 26

Brief Summary

The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16

  Percentage of participants who achieve ppPASI75 response, defined as improvement greater than or equal to (\>=) 75 percent (%) in the ppPASI score at Week 16 will be reported. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.

  Week 16

Secondary Outcomes (16)

• Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48

  Baseline and Weeks 16, 24 and 48

• Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48

  Baseline, Weeks 16, 24 and 48

• Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48

  Weeks 16, 24 and 48

• Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48

  Weeks 16, 24 and 48

• Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48

  Weeks 16, 24 and 48

Study Arms (2)

Guselkumab Group

EXPERIMENTAL

Participants will receive guselkumab 100 mg SC injections at Weeks 0, 4, 12 and placebo subcutaneous (SC) injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injections at Weeks 20, 28, 36, and 44 in open-label phase.

Drug: Guselkumab 100 mg; Drug: Placebo

Placebo Group

PLACEBO COMPARATOR

Participants will receive placebo SC injection at Weeks 0, 4, 12 and guselkumab 100 mg SC injection at Week 16 in double-blind phase followed by guselkumab 100 mg SC injection at Week 20, 28, 36, and 44 in open-label phase.

Drug: Guselkumab 100 mg; Drug: Placebo

Interventions

Guselkumab 100 mg DRUG

Guselkumab 100 mg will be administered as SC injection.

Also known as: CNTO1959

Guselkumab Group; Placebo Group

Placebo DRUG

Placebo will be administered as SC injection.

Guselkumab Group; Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Should have all the following: A confirmed diagnosis of moderate-to-severe palmoplantar-non-pustular psoriasis with palm and/or sole involvement and at least one plaque at a body site other than the palms and soles for at least 6 months, to confirm a diagnosis of chronic psoriasis; psoriatic area and severity index (PASI) score greater than or equal to (\>=) 3 and less than (\<) 10 at screening and at baseline; Palmoplantar Investigator Global Assessment (ppIGA) score \>=3 at screening and at baseline
• Should be eligible to receive biological treatments; only participants who are naive to biological treatments can be included
• A woman of childbearing potential must have a negative urine pregnancy test at screening and at Week 0
• Agree not to receive a live virus or live bacterial vaccination during the study, or within 12 weeks after the last administration of study intervention
• Agree to avoid prolonged sun exposure and agree not to use tanning booths or other ultraviolet (UV) light sources from the first administration of study intervention through 12 weeks after the final dose of study intervention (Week 56)

You may not qualify if:

• Currently has palmoplantar pustulosis, pustular psoriasis, or any other forms other than plaque-type psoriasis (e.g, erythrodermic, guttate), or hyperkeratotic eczema
• Has current drug-induced psoriasis (eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
• Has received prior systemic treatment with biological agents or Janus Kinase (JAK) inhibitors
• Has had prior exposure, known and reported intolerance to guselkumab or excipients, or ineligible to treatment with biological agents
• Is infected with human immunodeficiency virus (HIV, positive serology for HIV antibody)

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (26)

CHU Bordeaux - Hopital St Andre

Bordeaux, 33000, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

CHU de Nice Hopital de l Archet

Nice, 06200, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Fachklinik Bad Bentheim

Bad Bentheim, 48455, Germany

Location

University Hospital Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Frankfurt

Frankfurt am Main, 60590, Germany

Location

MensingDerma research GmbH

Hamburg, 22391, Germany

Location

Universitätsklinikum Schleswig Holstein Campus Lübeck

Lübeck, 23538, Germany

Location

Universitätsmedizin der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Centrovital

Witten, 58453, Germany

Location

AOU di Cagliari

Cagliari, 09124, Italy

Location

P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

Catania, 95123, Italy

Location

Ospedale Santa Chiara AO Universitaria Pisana

Pisa, 56126, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46026, Spain

Location

Hosp. de Manises

Valencia, 46940, Spain

Location

Russell's Hall Hospital

Dudley, DY1 2HQ, United Kingdom

Location

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Barts Health NHS Trust

London, E11 1NR, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Psoriasis

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen-Cilag Ltd. Clinical Trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

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: June 25, 2019
• First Posted: June 26, 2019
• Study Start: September 3, 2019
• Primary Completion: March 2, 2021
• Study Completion: November 30, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (8); IT (4); ES (5); GB (5); FR (4)