Multi-Center PAMPA Study

NYU Langone Health

Status and phase: Enrolling; Phase 4

Conditions: Psoriasis

Treatments: Drug: Guselkumab; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05004727

20-01158

Details and patient eligibility

About

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 our 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.

Enrollment: 176 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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176 participants in 3 patient groups, including a placebo group

Guselkumab + Topicals (GUS)

Experimental group

Treatment:

Drug: Guselkumab

Placebo + Topicals (PBO)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Guselkumab

Standard-of-Care Therapy (SOC)

No Intervention group

Description:

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).