Preventing Arthritis in a Multi-Center Psoriasis At-Risk Cohort

Plain English Summary

Multi-Center PAMPA Study is a Phase 4 clinical trial sponsored by NYU Langone Health studying Psoriasis. This study tests if the drug guselkumab can prevent psoriatic arthritis (PsA) in people who have psoriasis and are at high risk. It is for adults with psoriasis who have had it for at least 2 years and show certain signs of inflammation in their joints. Participants will receive either guselkumab or a placebo (a dummy injection) through regular shots. Alternative treatments for psoriasis include other medications or light therapy, but this study focuses on preventing joint disease. The trial aims to enroll 176 participants.

Official Summary

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care. The primary objective of the proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will: 1. Diminish MSKPDUS findings at 24 weeks, and 2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a psoriasis diagnosis for at least 2 years. Individuals showing specific signs of inflammation in their joints via ultrasound, even if they don't currently have joint pain. People who are not currently taking immunosuppressive medications or biologic therapies for psoriasis. Individuals without active cancer, certain pre-existing joint conditions, or active infections. This trial is studying Psoriasis, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how inflammation in the joints, detected by ultrasound, changes over 24 weeks, indicating if the treatment reduces early signs of psoriatic arthritis. The specific primary outcome measures are: Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score (Baseline, Week 24). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial addresses a critical need to prevent psoriatic arthritis, a painful condition that can develop from psoriasis, by intervening early in at-risk individuals. This research targets Psoriasis, where improved treatment options are needed.

Investor Insight

This trial signals a significant investment in preventing a common complication of psoriasis, potentially expanding the market for guselkumab and improving patient outcomes, with a high probability of This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor if you have psoriasis and are experiencing joint stiffness or swelling, even if mild. Understand that you will receive either the study drug or a placebo, and participation involves regular clinic visits and injections for up to two years. Be prepared for regular blood tests and imaging scans to monitor your condition and the drug's effects. This trial is currently recruiting participants. The trial is being conducted at 5 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: TRIPLE
• Enrollment: 176 participants

Interventions

• DRUG: Guselkumab — Guselkumab 100 mg 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (month 0 to month 24 for arm 1; week 24 to month 24 for arm 2).
• DRUG: Placebo — • Placebo to Guselkumab 1 mL liquid formulation in a single-dose pre-filled syringe administered by subcutaneous injection at Week 0, Week 4 and every 8 weeks thereafter (Month 0 to Week 20 for Arm 2).

Primary Outcomes

• Change in Musculoskeletal, Power Doppler Ultrasound (MSK-PDUS) Composite Score (Baseline, Week 24)

Secondary Outcomes

• Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 2 (Year 2)
• Percentage of Patients Transitioning to Psoriatic Arthritis (PsA) by Modified CASPAR Criteria at Year 1 (Year 1)
• Severity of PsA at the time of synovio-entheseal development (Year 2)
• Change in the ultrasound composite score of synovitis (Baseline, week 24)
• Change in Madrid Sonographic Enthesis Index (MASEI) Score (Baseline, week 24)

Full Eligibility Criteria

Inclusion Criteria:

1. 18 years old or older;
2. Both male \& female;
3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
4. Willing and able to provide informed consent;
5. Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration \>2 years and Psoriasis Body Surface Area (BSA) \>3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of \>3.36

Exclusion Criteria:

1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
3. RA seropositivity (mid-high RF/ACPA titers);
4. Current active malignancy;
5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
7. Known hypersensitivity to the study agent.

Trial Locations

• Brigham and Women's Hospital, Boston, Massachusetts, United States
• NYU Langone Health, New York, New York, United States
• University of Rochester Medical Center (URMC), Rochester, New York, United States
• Memorial University, St. John's, Newfoundland and Labrador, Canada
• Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada

Frequently Asked Questions

Related Conditions

• Psoriasis
• Psoriatic Arthritis
• Inflammatory Arthritis
• Autoimmune Diseases
• Dermatology
• Rheumatology
• Joint Inflammation
• Musculoskeletal Disorders
• Gastroenterology
• Immunology

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