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Monoclonal Antibodies

Guselkumab for Psoriasis (PAMPA Trial)

Phase 4
Recruiting
Led By Jose Scher, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants)
18 years old or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 2
Awards & highlights

PAMPA Trial Summary

This trial will test whether the intervention of Guselkumab will reduce the risk for developing psoriatic arthritis in high-risk psoriasis patients.

Who is the study for?
Adults with psoriasis for over 2 years, a body surface area affected by psoriasis greater than 3%, and specific ultrasound findings are eligible. They must be able to consent and not have other joint conditions, active cancer, signs of inflammatory joint issues, or be on certain immune-suppressing drugs.Check my eligibility
What is being tested?
The trial is testing Guselkumab against a placebo in high-risk psoriasis patients across multiple centers in North America. It aims to see if the drug can reduce musculoskeletal ultrasound abnormalities and prevent arthritis linked to psoriasis after two years.See study design
What are the potential side effects?
Potential side effects of Guselkumab may include reactions at the injection site, infections due to lowered immunity, headaches, stomach pain, and allergic reactions among others.

PAMPA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with psoriasis by a dermatologist for at least 2 years.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.

PAMPA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and year 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score
Arthritis, Psoriatic
Secondary outcome measures
Achieved IGA mod 2011 Score
Change in EuroQol-5D (EQ-5D) Score
Change in Functional Assessment of Chronic Illness Therapy (FACIT) Scale
+7 more

Side effects data

From 2020 Phase 4 trial • 1027 Patients • NCT03573323
1%
Nasopharyngitis
1%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ixekizumab Post-Treatment Follow Up
Ixekizumab
Guselkumab
Guselkumab Post-Treatment Follow Up

PAMPA Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Guselkumab + Topicals (GUS)Experimental Treatment1 Intervention
Group II: Standard-of-Care Therapy (SOC)Active Control1 Intervention
In this third, non-randomized arm, patients would continue treatment with topical therapy or UVB, as part of our ongoing natural history of disease registries. This arm will include participants fulfilling RM-PsASon criteria but also those that do not (to serve as "negative" controls).
Group III: Placebo + Topicals (PBO)Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guselkumab
2015
Completed Phase 4
~5990

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Psoriasis treatments often target specific components of the immune system to reduce inflammation and slow the overproduction of skin cells. Biologic agents, such as Guselkumab, work by inhibiting interleukin-23 (IL-23), a cytokine that plays a crucial role in the inflammatory process of psoriasis. By blocking IL-23, these treatments can significantly reduce the symptoms and progression of the disease. Other biologics target different interleukins, such as IL-17 and IL-12/23, or tumor necrosis factor-alpha (TNF-alpha), all of which are involved in the inflammatory pathways of psoriasis. Understanding these mechanisms is important for patients as it helps them comprehend how these treatments can effectively manage their condition and improve their quality of life.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,374 Previous Clinical Trials
840,989 Total Patients Enrolled
2 Trials studying Psoriasis
1,022 Patients Enrolled for Psoriasis
Janssen Scientific Affairs, LLCIndustry Sponsor
159 Previous Clinical Trials
580,169 Total Patients Enrolled
4 Trials studying Psoriasis
15,891 Patients Enrolled for Psoriasis
Jose Scher, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
1,046 Total Patients Enrolled
2 Trials studying Psoriasis
1,022 Patients Enrolled for Psoriasis

Media Library

Guselkumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05004727 — Phase 4
Psoriasis Research Study Groups: Placebo + Topicals (PBO), Standard-of-Care Therapy (SOC), Guselkumab + Topicals (GUS)
Psoriasis Clinical Trial 2023: Guselkumab Highlights & Side Effects. Trial Name: NCT05004727 — Phase 4
Guselkumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004727 — Phase 4
~137 spots leftby Dec 2025
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