Psoriasis GuttatePhase 4TIGNCT04645355
Guselkumab Immunogenetics
A Phase 4 study testing Guselkumab in people with Psoriasis Guttate and Plaque Psoriasis, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Guttate, Plaque Psoriasis
- What is being tested?
- Guselkumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 4 Apr 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Psoriasis and Skin Treatment Center
San Francisco, California, 94118
About this study
Official title: 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.
Read the 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.
- Conditions
- Psoriasis Guttate, Plaque Psoriasis
- Being tested
- Guselkumab
- Medical subject headings
- Guttate Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuselkumabDrug
All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44
| Study group | Role | What they receive |
|---|---|---|
| New-onset guttate psoriasis | Experimental | 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. Receives: Drug: Guselkumab |
| Chronic plaque psoriasis | Experimental | 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. Receives: Drug: Guselkumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lesional CD4+ T Effector Cells
Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17 between baseline and week 12
Measured: baseline and week 12
Lesional CD8+ T Effector Cells
Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17 between baseline and week 12
Measured: baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 Mar 2021
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis GuttateStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a single center, open-label study. Twenty-five subjects are planned (15 with new-onset guttate psoriasis and 10 with chronic plaque psoriasis). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Biotech, Inc.
- Responsible party
- Sponsor
- Investigators
- Wilson Liao, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645355
- Sponsor's protocol ID
- 20-32273
- Acronym
- TIG
- Status last verified
- May 2026
- First submitted
- 20 Nov 2020
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenetic Profiling of Guselkumab for the Treatment of Plaque and Guttate Psoriasis
- ClinicalTrials.gov ID
- NCT04645355
- Acronym / sponsor ID
- TIG / 20-32273
- Conditions
- Psoriasis Guttate, Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Janssen Biotech, Inc.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 27 Nov 2020 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single center, open-label study. Twenty-five subjects are planned (15 with new-onset guttate psoriasis and 10 with chronic plaque psoriasis). Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44.
| Arm | Type | Receives |
|---|---|---|
| New-onset guttate psoriasis | Experimental | Drug: GuselkumabSubjects 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. |
| Chronic plaque psoriasis | Experimental | Drug: GuselkumabSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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%.
Key exclusion criteria (29 listed)
- 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.
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 |
|---|---|---|
| GuselkumabAll subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44 | Drug | Chronic plaque psoriasis, New-onset guttate psoriasis |
Primary outcome
Lesional CD4+ T Effector Cells
Time frame: baseline and week 12
Mean change from baseline in percent of lesional CD4+ T effector cells producing IL-17 between baseline and week 12
Lesional CD8+ T Effector Cells
Time frame: baseline and week 12
Mean change from baseline in percent of lesional CD8+ T effector cells producing IL-17 between baseline and week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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
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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.
Wilson Liao, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guselkumab in people with Psoriasis Guttate and Plaque Psoriasis, run by University of California, San Francisco at 1 site in United States.
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 19 inclusion and 29 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lesional CD4+ T Effector Cells (time frame: baseline and week 12). The study lists 2 primary outcomes in all. 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 23 Jun 2026.