- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04645355
Guselkumab Immunogenetics (TIG)
March 6, 2024 updated by: University of California, San Francisco
Immunogenetic Profiling of Guselkumab for the Treatment of Plaque and Guttate Psoriasis
This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis.
Given the potential role of IL-23 in the pathogenesis of guttate psoriasis, guselkumab may be an effective option to treat the initial manifestation of guttate psoriasis.
This is a two-arm open-label study to evaluate the clinical and immunogenetic responses of patients with plaque or guttate psoriasis to treatment with guselkumab.
The primary objective of this study is to assess how treatment with guselkumab changes the immune milieu of the skin in patients with plaque or guttate psoriasis.
The secondary objectives of this study are to assess how treatment with guselkumab affects the quality of life and extent of skin disease in patients with plaque or guttate psoriasis.
Study Type
Interventional
Enrollment (Estimated)
25
Phase
- Phase 4
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: Marwa Hakimi, MD
- Phone Number: (415) 476-4701
- Email: marwa.hakimi@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94118
- Recruiting
- UCSF Psoriasis and Skin Treatment Center
-
Contact:
- Marwa Hakimi, MD
- Phone Number: 415-476-4701
- Email: marwa.hakimi@ucsf.edu
-
Principal Investigator:
- Wilson Liao, MD
-
-
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
For subjects with guttate psoriasis:
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of guttate psoriasis.
- Onset of guttate psoriasis within 12 months.
- Body surface area (BSA) involvement greater than or equal to 5%.
- PASI greater than or equal to 4.
- Subject is considered a candidate for phototherapy or systemic therapy.
- Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). Women of childbearing potential will be allowed to enroll provided they practice adequate forms of birth 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.
For subjects with chronic plaque psoriasis (control):
- Ability to provide written informed consent and comply with the protocol.
- At least 18 years of age.
- Diagnosis of plaque psoriasis.
- Duration of plaque psoriasis >5 years.
- Body surface area (BSA) involvement greater than or equal to 5%.
- Subject is considered a candidate for phototherapy or systemic therapy.
- Subject is unlikely to conceive due to male, post-menopausal, or using adequate contraceptive (barrier, hormonal, implant, or permanent sterilization methods). Women of childbearing potential will be allowed to enroll provided they practice adequate forms of birth 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.
Exclusion Criteria:
For subjects with guttate psoriasis:
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age or older than 70 years.
- Have a history of active, chronic or recurrent infectious disease including HIV, hepatitis B, or hepatitis C.
- Have active tuberculosis or latent tuberculosis without at least 4 weeks of treatment with isoniazid.
- Have current signs or symptoms of severe, progressive, or uncontrolled medical disease.
- Known allergies, hypersensitivity, or intolerance to guselkumab (TremfyaTM) excipients.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening)
- Are pregnant, nursing, or planning a pregnancy while enrolled in the study or for 12 weeks after the study agent injection for women or are planning to father a child while enrolled in the study or for 12 weeks after the last study agent injection.
- Are participating in another study using an investigational agent or procedure during participation in this study.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- Subjects possess other diagnoses that, in the investigator's opinion interfere with the evaluation of the subject's guttate psoriasis.
- Pre-existing psoriasis of any type for longer than 6 months. (i.e. plaque, guttate, palmoplantar, pustular, erythrodermic)
- Previous treatment for psoriasis with phototherapy (narrowband ultraviolet (UV) B, broadband UVB, or UVA), systemic agents (methotrexate, acitretin, cyclosporine, apremilast), or biologic agents (etanercept, adalimumab, ustekinumab, secukinumab, etc.)
For subjects with chronic plaque psoriasis:
- Subject is unable to provide written informed consent or comply with the protocol.
- Subject is younger than 18 years of age or older than 70 years.
- Have a history of active, chronic or recurrent infectious disease, including HIV, hepatitis B, or hepatitis C.
- Have active tuberculosis or latent tuberculosis without at least 4 weeks of treatment with isoniazid.
- Have current signs or symptoms of severe, progressive, or uncontrolled medical disease.
- Known allergies, hypersensitivity, or intolerance to guselkumab (TremfyaTM) excipients.
- Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.
- Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or cervical carcinoma in situ that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to screening)
- Are pregnant, nursing, or planning a pregnancy while enrolled in the study or for 12 weeks after the study agent injection for women or are planning to father a child while enrolled in the study or for 12 weeks after the last study agent injection.
- Are participating in another study using an investigational agent or procedure during participation in this study.
- Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
- Subjects possess other diagnoses that, in the investigator's opinion, interfere with the evaluation of the subject's plaque psoriasis.
- Prior history of guttate psoriasis.
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: New-onset guttate psoriasis
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.
|
All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44
|
Experimental: Chronic plaque psoriasis
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.
|
All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lesional CD4+ T effector cells
Time Frame: baseline and week 44
|
Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17
|
baseline and week 44
|
Lesional CD8+ T effector cells
Time Frame: baseline and week 44
|
Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17
|
baseline and week 44
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Wilson Liao, MD, University of California, San Francisco
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)
March 1, 2021
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
November 20, 2020
First Submitted That Met QC Criteria
November 20, 2020
First Posted (Actual)
November 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 6, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-32273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Non-identifying clinical and research data may be shared with Janssen Biotech, UCSF and FDA, as well as other qualified scientists upon publication and upon request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
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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