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

May 28, 2026 updated by: CorEvitas
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Study population must be at least 18 years of age and is 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.

Description

Inclusion Criteria:

The inclusion criteria for this study will be as follows:

  1. Patient is at least 18 years of age at the time of study enrollment
  2. 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.
  3. Patient is initiating new Eligible Medication for the first time for the treatment of PSO.
  4. Patient is willing and able to provide informed consent to participate in this study.
  5. 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:

  1. Patient is participating in a blinded clinical trial.
  2. Patients that do not receive at least 1 dose of the advanced therapy within 14 days following the Enrollment/Baseline visit for the study.
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Day 0), Week 2, 4 and 16 weeks after initiation of advanced therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorEvitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2025

Primary Completion (Estimated)

December 1, 2035

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CorEvitas-PSO-505

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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