- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04439526
A Study of Guselkumab in Naive or Bio-experienced Participants With Regional (Facial and Genital) Psoriasis (GULLIVER)
January 3, 2024 updated by: Janssen-Cilag S.p.A.
Observational Study on GUselkumab: Effectiveness and Impact on quaLity of LIfe in naïVE or Bio Experienced Patients With Regional (Facial and Genital) Psoriasis (GULLIVER Study)
The purpose of this study is to investigate the effectiveness profile of guselkumab used in a real-life setting in participants with moderate facial and/or genital psoriasis.
Effectiveness will be evaluated using the static Physicians Global Assessment (sPGA) for the facial region and the sPGA for the genital region.
Study Overview
Study Type
Observational
Enrollment (Actual)
356
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Contact
- Phone Number: 844-434-4210
- Email: Participate-In-This-Study@its.jnj.com
Study Locations
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Bari, Italy, 70124
- Policlinico di Bari Ospedale Giovanni XXIII
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Bologna, Italy, 40138
- Policlinico Sant'Orsola Malpighi
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Cagliari, Italy, 09124
- Ospedale San Giovanni di Dio
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Catania, Italy, 95123
- PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
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Cava de' Tirreni, Italy, 84013
- Azienda Ospedaliera Universitaria - OO.RR. San Giovanni di Dio Ruggi d'Aragona
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Chieti, Italy, 66100
- Università D'Annunzio
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Cona, Italy, 44124
- Azienda Ospedaliero Universitaria di Ferrara
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Erice, Italy, 91016
- Ospedale Sant'Antonio Abate
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Firenze, Italy, 50125
- Azienda Sanitaria di Firenze-Ospedale Piero Palagi
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Genova, Italy, 16132
- IRCCS Aor San Martino IST
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L'Aquila, Italy, 67100
- Ospedale San Salvatore
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Messina, Italy, 98125
- Azienda Ospedaliera Universitaria Policlinico G. Martino
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Messina, Italy, 98158
- AO Papardo
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Milano, Italy, 20132
- IRCCS Ospedale San Raffaele
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Milano, Italy, 20122
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
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Modena, Italy, 41124
- Az. Ospedaliero - Universitaria di Modena
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Napoli, Italy, 80131
- Azienda Ospedaliera Universitaria Federico II
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Napoli, Italy, 80131
- Azienda Ospedaliera Univ.- Università Degli studi della Campania - Luigi Vanvitelli
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Novara, Italy, 28100
- Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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Padova, Italy, 35128
- Azienda Ospedaliera Universitaria di Padova
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Palermo, Italy, 90127
- Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
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Parma, Italy, 43126
- Ospedale Maggiore, Azienda Ospedaliero Universitaria di Parma
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Perugia, Italy, 06129
- Ospedale S. Maria Della Misericordia
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Pisa, Italy, 56126
- Azienda Ospedaliero Universitaria Pisana
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Reggio Calabria, Italy, 89124
- Grande Ospedale Metropolitano 'Bianchi-Melacrino-Morelli' Reggio Calabria
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Reggio Emilia, Italy, 42123
- Arcispedale Santa Maria Nuova - IRCCS
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Roma, Italy, 00168
- Policinico A Gemelli
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Roma, Italy, 00161
- AOU Policlinico Umberto I
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Roma, Italy, 00144
- ISG San Gallicano
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Roma, Italy, 00167
- Istituto Dermopatico dell'Immacolata
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Roma, Italy, 00183
- Policlinico Tor Vergata
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Rozzano, Italy, 20089
- Istituto Clinico Humanitas
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Terni, Italy, 05100
- Azienda Ospedaliera Santa Maria
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Terracina, Italy, 04019
- Ospedale Alfredo Fiorini
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Torino, Italy, 10126
- Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
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Torrette Di Ancona, Italy, 60030
- A.O. Universitaria Ospedali Riuniti di Ancona
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Udine, Italy, 33100
- Azienda Ospedaliero Universitaria S.Maria Della Misericordia
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Venezia, Italy, 30122
- Ospedale S.S. Giovanni e Paolo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Outpatients with facial and/or genital psoriasis, receiving guselkumab treatment as standard of care (SOC) in clinical practice, will be observed.
The primary data source for the study will be the medical records of each participating participant.
Description
Inclusion Criteria:
Participants included in the study:
- must have a first or confirmed diagnosis of psoriasis, requiring systemic treatment with significant involvement (defined as a Static Physician's Global Assessment [sPGA] score greater than or equal to [>=] 3) involving the facial and/or genital regions
- must have started treatment according to the approved indication as described in the current version of summary of product characteristics (SmPC) of the product approved in Italy. Enrollment may occur at any time after the first injection of guselkumab but before completion of the next visit at week 4 or 12 as scheduled according to common clinical practice
- must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria:
Participants will be excluded from the study if they:
- have any contraindication to the use of guselkumab, as stated in the current SmPC of the product approved in Italy
- received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of guselkumab treatment
- are currently enrolled in another clinical trial or investigational study
- are currently enrolled in an observational study sponsored or managed by a Janssen company
- participant unable to read, to write, to understand and sign the informed consent form (ICF)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Participants with Facial Psoriasis
Participants with moderate facial psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
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Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.
Other Names:
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Participants with Genital Psoriasis
Participants with moderate genital psoriasis who are being treated with guselkumab in real world practice will be observed in this study.
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Participants with moderate facial and/or genital psoriasis treated with guselkumab (as prescribed by their physician) in real world practice will be observed in this study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Static Physician's Global Assessment (sPGA) Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Facial Region
Time Frame: Week 52
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The sPGA for the facial region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time.
The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
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Week 52
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Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at Least a 2-grade Improvement for the Genital Region
Time Frame: Week 52
|
The sPGA for the genital region is a physician global ratings of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time.
The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
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Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Facial Region
Time Frame: Week 12, Week 28
|
The sPGA for the facial region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time.
The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
|
Week 12, Week 28
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Percentage of Participants Achieving a sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement for the Genital Region
Time Frame: Week 12, Week 28
|
The sPGA for the genital region is a physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time.
The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
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Week 12, Week 28
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Change from Baseline in the Dermatology Quality of life Index (DLQI) Total Score for the Facial Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life.
Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life.
The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life.
Higher scores indicate greater impact on quality of life of participants.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in the DLQI Total Score for the Genital Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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The DLQI is a 10-item questionnaire that measures the impact of skin disease on participants' quality of life.
Each question is evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate greater impact on quality of life.
The DLQI is calculated by summing the scores of the questions and ranges from 0 to 30 where 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life.
Higher scores indicate greater impact on quality of life of participants.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in the SF-36 Physical Component Summary (PCS) Score for the Facial Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Each item is scored on a scale of 0 to 100.
Worst value is 0 and best value is 100.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in the SF-36 PCS Score for the Genital Region
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Each item is scored on a scale of 0 to 100.
Worst value is 0 and best value is 100.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in the SF-36 Mental Component Summary (MCS) Score for the Facial Region
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Each item is scored on a scale of 0 to 100.
Worst value is 0 and best value is 100.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in the SF-36 MCS Score for the Genital Region
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health.
Each item is scored on a scale of 0 to 100.
Worst value is 0 and best value is 100.
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in Pain/Itch/Discomfort Visual Analogue Scale (VAS) Scores for the Facial Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100.
Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Symptom" and 100 = "Worst Symptom Imaginable".
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in Pain/Itch/Discomfort VAS Scores for the Genital Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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Each VAS is a patient-rated assessment designed to evaluate the intensity of pain, itch or discomfort on a linear scale of 0-100.
Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Symptom" and 100 = "Worst Symptom Imaginable".
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Facial Region
Time Frame: Baseline, Week 12, Week 28, Week 52
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Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100.
Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Sign" and 100 = "Worst Sign Imaginable".
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Baseline, Week 12, Week 28, Week 52
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Change from Baseline in Redness/Scaling/Thickness VAS Scores for the Genital Region
Time Frame: Baseline, Week 12, Week 28, Week 52
|
Each VAS is a patient-rated assessment designed to evaluate the intensity of redness, scaling, and thickness on a linear scale of 0-100.
Operationally, each VAS is represented by a 100 mm horizontal line anchored by extreme descriptors at each end, where 0 = "No Sign" and 100 = "Worst Sign Imaginable".
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Baseline, Week 12, Week 28, Week 52
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Percentage of Participants Achieving an Overall sPGA Score of Clear (0) or Almost Clear (1) and at least a 2-grade Improvement Among Participants with an Overall sPGA Score greater than or equal to (>=) 3 at baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The overall sPGA is defined as physician global rating of psoriasis severity, which evaluates plaque thickness, scaling and erythema, at a given point in time.
The sPGA comprises a 6-point rating scale from 0 to 5 where 0 = clear, 1 = minimal/ almost clear, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe.
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Baseline, Week 12, Week 28, Week 52
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Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 100 Response Among Participants with a PASI Score >10 at Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
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The PASI is a tool to assess and grade the severity of psoriasis and response to therapy.
In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities.
Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status.
A PASI 100 response is defined as 100 percent (%) improvement in PASI score from baseline.
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Baseline, Week 12, Week 28, Week 52
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Percentage of Participants Achieving a PASI 90 Response Among Participants with a PASI Score >10 at Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The PASI is a tool to assess and grade the severity of psoriasis and response to therapy.
In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities.
Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status.
A PASI 90 response is defined as >=90% improvement in PASI score from baseline.
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Baseline, Week 12, Week 28, Week 52
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Percentage of Participants Achieving a PASI 75 Response Among Participants with a PASI Score >10 at Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The PASI is a tool to assess and grade the severity of psoriasis and response to therapy.
In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities.
Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status.
A PASI 75 response is defined as >=75% improvement in PASI score from baseline.
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Baseline, Week 12, Week 28, Week 52
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Mean Percent Change in PASI Score from Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The PASI is a tool to assess and grade the severity of psoriasis and response to therapy.
In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities.
Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status.
Mean percent change from baseline in PASI score will be assessed.
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Baseline, Week 12, Week 28, Week 52
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Mean Change in Percent Body Surface Area (BSA) from Baseline in Participants with BSA >10% at Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
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BSA affected by psoriasis of <5% is considered mild psoriasis, 5-10% moderate psoriasis, and >10% severe psoriasis.
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Baseline, Week 12, Week 28, Week 52
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Percentage of Participants Achieving an Absolute PASI Score of Less Than (<) 3 Among Participants with a PASI Score of >10 at Baseline
Time Frame: Baseline, Week 12, Week 28, Week 52
|
The PASI is a tool to assess and grade the severity of psoriasis and response to therapy.
In the PASI, the body is divided into four areas: the head, trunk, upper extremities and lower extremities.
Each of these areas is assessed separately for the percentage of surface area involved, which translates to a numeric score that ranges from 0 to 6, and for degree of erythema, scaling and induration/thickness, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72, with higher score indicating more severe disease status.
Percentage of participants who achieve an absolute PASI score <3 will be assessed.
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Baseline, Week 12, Week 28, Week 52
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Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: Week 52
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The TSQM-9 is a 9-item generic participant-reported outcome instrument to assess participants' satisfaction with medication and covers domains of effectiveness, convenience and global satisfaction.
The instrument is scored by domain with scores ranging from 0-100, where a lower score indicates lower satisfaction.
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Week 52
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Persistency with Guselkumab
Time Frame: Up to Week 52
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Persistency with treatment is defined as duration of time from initiation to last dose of therapy, as well as the percentage of participants still on treatment at the end of the observation period.
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Up to Week 52
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Narrative Plots at Enrollment and Week 52
Time Frame: Baseline (at enrollment) and Week 52
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Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the week 52 visit.
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Baseline (at enrollment) and Week 52
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Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 52
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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.
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Up to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial, Janssen-Cilag S.p.A.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2020
Primary Completion (Actual)
November 21, 2023
Study Completion (Actual)
November 21, 2023
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (Actual)
June 19, 2020
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 3, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108761
- CNTO1959PSO4013 (Other Identifier: Janssen-Cilag S.p.A., Italy)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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