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NCT Number: NCT07615712

PPD™ CorEvitas™ Psoriasis (PSO) Rapid Response Non-Interventional Study

This is a 16-week prospective, single-arm cohort, study of patients initiating advanced therapy for the treatment of moderate-to-severe plaque PSO. Eligible patients must be willing to be seen in-person by their treating physician for a Baseline visit (with first dose of the advanced therapy occurring within 14 days), and at 2 (+/- 5 days), 4 (+/- 5 days), and 16 weeks (+14 days) calculated based on date of first dose of the advanced therapy and must provide informed consent prior to enrolling in the study or completing study-specific questionnaires or procedures. Data will be collected from both subjects and their treating dermatology provider at predetermined scheduled intervals (Baseline, Week 2, Week 4, and Week 16) using a structured and standardized data collection tool.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Data collected through the study may be used to address a range of research questions and use cases and objectives, including but not limited to study

  • Creation of a cohort of psoriasis subjects to describe the clinical and patient-reported outcomes (PRO) and changes at 2,4, and 16 weeks after initiation of the advanced therapy.
  • Inform clinical decision making by subjects and treating providers. This will be enabled through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the recording of medication utilization data.
  • Describe subject characteristics (i.e. comorbidity, medication history, sociodemographic) at baseline.
  • For subjects with a dermatologist-confirmed diagnosis of psoriatic arthritis at baseline, to describe the joint pain and patient wellness.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The inclusion criteria for this study will be as follows:

  • Patient is at least 18 years of age at the time of study enrollment
  • Patient has a diagnosis of moderate to severe plaque psoriasis based on an Investigator Global Assessment (IGA, part of routine care) score of 3 or 4 at the time of Enrollment.
  • Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
  • Patient is willing and able to provide informed consent to participate in this study.
  • Patient is willing to be seen in-person by their treating dermatology provider at two (2), four (4), and sixteen (16) weeks following initiation of the advanced therapy.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in the study:

  • Patient is participating in a blinded clinical trial.
  • Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
  • Patients cannot be concurrently enrolled in both the CorEvitas PSO Registry and the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.

A. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study.

B. Patients otherwise meeting eligibility criteria can be enrolled in the CorEvitas Psoriasis (PSO) Rapid Response Non-Interventional Study C. Following completion or at time of Exit from the CorEvitas Psoriasis (PSO) Rapid Response Non Interventional Study, patients will be eligible to enroll into the CorEvitas PSO Registry for long term follow up at the standard of care cadence supported by the registry. A separate Informed consent will be obtained.

Treatment and study plan

Observational (Non-Interventional) Registry

Other

This is an observational (non-interventional) registry

Primary outcomes

  1. Creation of a cohort of psoriasis subjects

    Time frame: Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy

    Creation of a cohort of psoriasis subjects to describe the changes at 2,4, and 16 weeks after initiation of the advanced therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Cathy Cheney

CONTACT

[email protected]

+1 508 408 5433

Sponsors and collaborators

Lead sponsor

CorEvitas

Network

Registry information

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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