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Monoclonal Antibodies
Guselkumab for Psoriasis (TIG Trial)
Phase 4
Recruiting
Led By Wilson Liao, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For subjects with chronic plaque psoriasis (control): At least 18 years of age
For subjects with chronic plaque psoriasis (control): Physical exam with no evidence of active skin infection and/or other findings that indicate chronic disease or concomitant inflammatory/immune-mediated skin disease other than psoriasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 44
Awards & highlights
TIG Trial Summary
This trial is testing a new psoriasis drug, guselkumab, to see if it is effective and safe.
Who is the study for?
Adults aged 18-70 with recent onset guttate psoriasis or long-standing plaque psoriasis, covering at least 5% of their body. Participants must be able to consent and follow the study plan. Women who can have children should use effective birth control. Excluded are those with certain infections like TB, HIV, hepatitis B/C, other skin diseases, severe illnesses, history of cancer (with some exceptions), or past psoriasis treatments including biologics.Check my eligibility
What is being tested?
The trial is testing guselkumab's effects on two types of psoriasis: new-onset guttate and chronic plaque. It's an open-label study where all participants know they're receiving guselkumab and are monitored for how their immune system responds to the treatment.See study design
What are the potential side effects?
Guselkumab may cause side effects such as allergic reactions to its components, injection site reactions (like pain or swelling), headaches, joint pain, stomach issues and potentially increase the risk of infections due to immune system alterations.
TIG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 or older with chronic plaque psoriasis.
Select...
I have chronic plaque psoriasis without any active skin infections or other chronic diseases.
Select...
My guttate psoriasis affects 5% or more of my body.
Select...
I have had plaque psoriasis for more than 5 years.
Select...
I have been diagnosed with plaque psoriasis.
Select...
My psoriasis severity score is 4 or higher.
Select...
I have been diagnosed with guttate psoriasis.
Select...
My psoriasis affects 5% or more of my body.
TIG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and week 44
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 44
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Lesional CD4+ T effector cells
Lesional CD8+ T effector cells
Side effects data
From 2020 Phase 4 trial • 1027 Patients • NCT035733238%
Upper respiratory tract infection
5%
Nasopharyngitis
1%
Endometrial cancer stage iv
1%
Injection site reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guselkumab
Ixekizumab
Ixekizumab Post-Treatment Follow Up
Guselkumab Post-Treatment Follow Up
TIG Trial Design
2Treatment groups
Experimental Treatment
Group I: New-onset guttate psoriasisExperimental Treatment1 Intervention
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
Group II: Chronic plaque psoriasisExperimental Treatment1 Intervention
Subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44. At week 44, patients who have not achieved PASI 50 (nonresponders) will be removed from the trial. Patients who achieve between PASI 50 and PASI 75 (partial responders) will continue on drug throughout the remainder of the study. Patients who achieve PASI 75 or greater at week 44 (responders) will have their guselkumab therapy withdrawn and re-treated upon relapse.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,530 Total Patients Enrolled
15 Trials studying Psoriasis
348 Patients Enrolled for Psoriasis
Janssen Biotech, Inc.Industry Sponsor
29 Previous Clinical Trials
18,784 Total Patients Enrolled
6 Trials studying Psoriasis
3,246 Patients Enrolled for Psoriasis
Wilson Liao, MDPrincipal InvestigatorUniversity of California, San Francisco
4 Previous Clinical Trials
57 Total Patients Enrolled
2 Trials studying Psoriasis
31 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have guttate psoriasis and no history of HIV, hepatitis B, or C.I am not likely to conceive due to being male, post-menopausal, or using effective birth control.I am allergic to ingredients in Tremfya.I am 18 or older with chronic plaque psoriasis.I have guttate psoriasis and no current or past cancers, except for certain skin or cervical cancers that were treated successfully.I have guttate psoriasis and have tried treatments like phototherapy or medications.I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.I have chronic plaque psoriasis without any active skin infections or other chronic diseases.I have guttate psoriasis and a history or symptoms of lymph disease.I am not likely to conceive or am using effective birth control.I am under 18 or over 70 years old with chronic plaque psoriasis.My guttate psoriasis started within the last year.I have psoriasis and either active TB or untreated latent TB.I have guttate psoriasis with no skin infection or other chronic skin conditions.I have had guttate psoriasis before my current chronic plaque psoriasis.I have guttate psoriasis and either active TB or untreated latent TB.I am under 18 or over 70 years old with guttate psoriasis.I have chronic plaque psoriasis and a history of infections like HIV or hepatitis.I have other health issues that may affect the assessment of my psoriasis.My guttate psoriasis affects 5% or more of my body.I can sign and follow the study rules for my guttate psoriasis treatment.I have had plaque psoriasis for more than 5 years.I have been diagnosed with plaque psoriasis.I am allergic or sensitive to ingredients in Tremfya.I have had psoriasis for more than 6 months.My guttate psoriasis is severe, getting worse, or not under control.I am not pregnant, nursing, or planning to become pregnant or father a child during the study and for 12 weeks after.I have psoriasis and a history or signs of lymphatic system disease.My psoriasis severity score is 4 or higher.I am eligible for light or systemic treatment for my guttate psoriasis.I can sign and follow the study rules for my psoriasis treatment.If you have guttate psoriasis, you cannot have other conditions that might make it hard for the doctor to assess your guttate psoriasis.I have been diagnosed with guttate psoriasis.I am eligible for light or systemic treatment for my psoriasis.My psoriasis is severe, getting worse, or not under control.I am 18 or older with guttate psoriasis.I have chronic plaque psoriasis and no current or past cancers, except for certain skin or cervical cancers that were treated successfully.My psoriasis affects 5% or more of my body.
Research Study Groups:
This trial has the following groups:- Group 1: New-onset guttate psoriasis
- Group 2: Chronic plaque psoriasis
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment an unprecedented endeavor?
"As of today, there are nineteen ongoing studies looking into the effects of Guselkumab. These trials span across 287 cities and 57 nations, having first been conducted in 2018 by Janssen Research & Development LLC with a sample size of 1,406 participants. To date, thirty separate research endeavours have been carried out since then."
Answered by AI
Is there still an opportunity for candidates to take part in this experiment?
"Affirmative, clinicaltrials.gov data indicates that this research trial is actively searching for participants. It was first published on March 1st 2021 and recently updated on April 28th 2022. 25 patients must be enrolled at a single site in order for the study to be considered successful."
Answered by AI
Has Guselkumab been subject to any previous trial experiments?
"Presently, 19 clinical trials are exploring the efficacy of Guselkumab. Out of these investigations, 7 are conducting Phase 3 research. While Milan, Kansas is hosting a majority of analyses for this medication, there exist 2737 sites running experiments across the world."
Answered by AI
To what extent is the participant pool expanding for this clinical experiment?
"Affirmative, data hosted on clinicaltrials.gov demonstrates that this medical research is actively searching for individuals who meet its criteria. This project was initially posted on March 1st 2021 and the details of it were updated most recently on April 28th 2022. 25 people are expected to join from a single site."
Answered by AI
What perils, if any, are associated with the use of Guselkumab?
"The safety of Guselkumab is rated a 3 due to this treatment being approved for Phase 4 clinical trials."
Answered by AI
Who else is applying?
What site did they apply to?
UCSF Psoriasis and Skin Treatment Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I had been on Stalara for years and 100% clear as a result. I recently had three major surgeries back to back, which caused my legs to doubled in size which caused an outbreak. And also during the surgeries I went off taking Stalara.. when I was able to go back on, so all right, I did not seem to be able to respond the same way I had before and still had many plaques and open lesions. we switch the biologic I was on not seem to be responding so well. The itching is driving me nuts. I am willing to try anything to get this back under control.
PatientReceived 2+ prior treatments
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