PsoriasisPhase 3G-PLUSNCT03998683
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
A Phase 3 study testing Guselkumab 100 mg in people with Psoriasis, run by Janssen-Cilag Ltd. at 26 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Guselkumab 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 3 Sep 2019to 30 Nov 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
Germany8 sites
Fachklinik Bad Bentheim
Bad Bentheim, 48455
University Hospital Dresden
Dresden, 01307
Universitatsklinikum Frankfurt
Frankfurt am Main, 60590
MensingDerma research GmbH
Hamburg, 22391
Universitätsklinikum Schleswig Holstein Campus Lübeck
Lübeck, 23538
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Universitaetsklinikum Muenster
Münster, 48149
Centrovital
Witten, 58453
Spain5 sites
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916
Hosp. Univ. Infanta Leonor
Madrid, 28031
Hosp. Univ. 12 de Octubre
Madrid, 28041
Hosp. Univ. I Politecni La Fe
Valencia, 46026
Hosp. de Manises
Valencia, 46940
United Kingdom5 sites
Russell's Hall Hospital
Dudley, DY1 2HQ
Chapel Allerton Hospital
Leeds, LS7 4SA
Barts Health NHS Trust
London, E11 1NR
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Salford Royal NHS Foundation Trust
Salford, M6 8HD
France4 sites
CHU Bordeaux - Hopital St Andre
Bordeaux, 33000
Hôpital Edouard Herriot
Lyon, 69437
CHU de Nice Hopital de l Archet
Nice, 06200
Hopital Charles Nicolle
Rouen, 76031
Italy4 sites
AOU di Cagliari
Cagliari, 09124
P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'
Catania, 95123
Ospedale Santa Chiara AO Universitaria Pisana
Pisa, 56126
Istituto Clinico Humanitas
Rozzano, 20089
About this study
Official title: A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.
Read the detailed description
Chronic plaque psoriasis is the most common form of psoriatic skin disease; however, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and are correlated with an increased risk of psoriatic arthritis that may result in significant morbidity with functional impairment and greater impairment in quality of life. Therefore, the main aim of the study is to provide robust efficacy and safety data on guselkumab treatment for palmoplantar non-pustular psoriasis. The study comprises of a Screening Phase (4 Weeks [Week -4 to 0]), a Treatment Phase (up to Week 48) and a post-treatment follow-up phase (up to Week 56). Key efficacy assessments include physician assessments and patient-reported outcomes questionnaires. Safety evaluations will include 12-lead electrocardiogram at baseline, pregnancy testing and monitoring of vital signs at all visits and recording of adverse events throughout the study. Also, participants will be evaluated for signs and symptoms of active tuberculosis at all visits including follow-up visit. Biomarker assessments will include the evaluation of relevant markers in serum for all participants. The study will have an overall duration of 56 weeks.
- Conditions
- Psoriasis
- Being tested
- Guselkumab 100 mg, Placebo
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab 100 mgDrug
Also called CNTO1959
Guselkumab 100 mg will be administered as SC injection.
PlaceboDrug
Placebo will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Guselkumab 100 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 16
Secondary outcomes (16)
Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48
Change from baseline in BSA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups by measuring the arithmetic mean of the affected skin surface.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48
Change from baseline in absolute PASI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups.
Measured: Baseline, Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48
Percentage of participants achieving PASI 75 score (participants who achieve >=75% improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.
Measured: Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48
Percentage of participants achieving PASI 90 score (participants who achieve >=90 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.
Measured: Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48
Percenatge of participants who achieving PASI 100 score (participants who achieve >=100 % improvement in PASI score) at Weeks 16, 24 and 48 will be reported in guselkumab versus the placebo group. PASI is a common clinical tool used to measure the severity and extent of psoriasis. The PASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of disease of the palms and/or soles.
Measured: Weeks 16, 24 and 48
Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48
Change from baseline in ppQLI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. ppQLI assesses relevant dimensions affected by palmoplantar psoriasis (pain/discomfort, functionality, and social/activity limitations) to assess quality of life.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48
Change from baseline in DLQI score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. DLQI a 10-item questionnaire that can be used to assess overall quality-of-life.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48
Change from baseline in EQ-5D- 5L score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. EQ-5D-5L is a standardized instrument to measure health-related quality of life.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48
Change from baseline in ppIGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess psoriasis overall lesions.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48
Change from baseline in f-PGA score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups to assess fingernails separately for nail bed and nail matrix for signs of disease.
Measured: Baseline and Weeks 16, 24 and 48
Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48
Percentage of participants who achieve ppPASI75 response, defined as improvement >=75% in the ppPASI score at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. 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.
Measured: Weeks 24 and 48
Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48
Percentage of participants who achieve ppPASI90 response (participants who achieve >=90 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles.
Measured: Weeks 24 and 48
Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48
Percentage of participants who achieve ppPASI100 response (participants who achieve >=100 % improvement in the ppPASI score) at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. The ppPASI is an assessment tool based on the PASI that assesses erythema, pustules, desquamation and the extent of the affection of the palms and/or soles.
Measured: Weeks 24 and 48
Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48
Change from baseline in WPAI: PSO score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. WPAI-PSO is a questionnaire which includes 6 questions to measure work productivity and activity impairment related to skin psoriasis.
Measured: Baseline and Weeks 16, 24 and 48
Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48
Change from baseline in NRS:P score at Week 16 will be reported in the guselkumab versus placebo group and at Weeks 24 and 48 will be reported separately for guselkumab and placebo-crossover groups. NRS:P is a self-administered scale that assess pain intensity in participants.
Measured: Baseline and Weeks 16, 24 and 48
Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start3 Sep 2019
- Primary completion2 Mar 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998683
- Sponsor's protocol ID
- CR108611
- Other IDs
- 2018-003206-58, CNTO1959PSO3013, 2018
- Acronym
- G-PLUS
- Status last verified
- Dec 2021
- First submitted
- 25 Jun 2019
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Multicenter, Interventional, Randomized, Placebo-controlled Study Investigating the Efficacy and Safety of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
- ClinicalTrials.gov ID
- NCT03998683
- Acronym / sponsor ID
- G-PLUS / CR108611
- Conditions
- Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of guselkumab for the treatment of palmoplantar psoriasis.
Detailed description
Chronic plaque psoriasis is the most common form of psoriatic skin disease; however, there is growing evidence that other variants including scalp, nail, inverse, and palmoplantar psoriasis are prevalent, undertreated, and are correlated with an increased risk of psoriatic arthritis that may result in significant morbidity with functional impairment and greater impairment in quality of life. Therefore, the main aim of the study is to provide robust efficacy and safety data on guselkumab treatment for palmoplantar non-pustular psoriasis. The study comprises of a Screening Phase (4 Weeks [Week -4 to 0]), a Treatment Phase (up to Week 48) and a post-treatment follow-up phase (up to Week 56). Key efficacy assessments include physician assessments and patient-reported outcomes questionnaires. Safety evaluations will include 12-lead electrocardiogram at baseline, pregnancy testing and monitoring of vital signs at all visits and recording of adverse events throughout the study. Also, participants will be evaluated for signs and symptoms of active tuberculosis at all visits including follow-up visit. Biomarker assessments will include the evaluation of relevant markers in serum for all participants. The study will have an overall duration of 56 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guselkumab Group | Experimental | Drug: Guselkumab 100 mg, Drug: PlaceboParticipants 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. |
| Placebo Group | Placebo comparator | Drug: Guselkumab 100 mg, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guselkumab 100 mgAlso: CNTO1959Guselkumab 100 mg will be administered as SC injection. | Drug | Guselkumab Group, Placebo Group |
| PlaceboPlacebo will be administered as SC injection. | Drug | Guselkumab Group, Placebo Group |
Primary outcome
Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16
Time frame: 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.
16 secondary outcomes
Change from Baseline in Body Surface Area (BSA) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in absolute PASI Score at Weeks 16, 24 and 48
Time frame: Baseline, Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 75 Score at Weeks 16, 24 and 48
Time frame: Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 90 Score at Weeks 16, 24 and 48
Time frame: Weeks 16, 24 and 48
Percentage of Participants Achieving PASI 100 at Weeks 16, 24 and 48
Time frame: Weeks 16, 24 and 48
Change from Baseline in Palmoplantar Quality-of-Life Instrument (ppQLI) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in Dermatology Life Quality Index (DLQI) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in European Quality of Life, 5-Dimension, 5-Level (EQ-5D-5L) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in Palmoplantar Investigator Global Assessment (ppIGA) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in Fingernail-Physician Global Assessment (f-PGA) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Percentage of Participants who Achieve ppPASI75 response at Weeks 24 and 48
Time frame: Weeks 24 and 48
Percentage of Participants who Achieve ppPASI90 response at Weeks 24 and 48
Time frame: Weeks 24 and 48
Percentage of Participants who Achieve ppPASI100 response at Weeks 24 and 48
Time frame: Weeks 24 and 48
Change from Baseline in Work Productivity and Activity Impairment: Psoriasis (WPAI: PSO) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Change from Baseline in Numerical Rating Scale: Pain (NRS:P) Score at Weeks 16, 24 and 48
Time frame: Baseline and Weeks 16, 24 and 48
Number of Participants with Adverse Event (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 56 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
26 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Guselkumab 100 mg in people with Psoriasis, run by Janssen-Cilag Ltd. at 26 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Germany, Spain, United Kingdom, France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve Palmoplantar Pustulosis Psoriasis Area and Severity Index 75 (ppPASI75) Response at Week 16 (time frame: Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.