NCT07648602

Brief Summary

This is a 24-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 16 (+/- 5 days) and 24 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 16 and Week 24) using a structured and standardized data collection tool.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
129mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2026

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2036

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

10.6 years

First QC Date

June 5, 2026

Last Update Submit

June 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Creation of a cohort of psoriasis subjects

    Creation of a cohort of psoriasis subjects to describe the changes at 16 and 24 weeks after initiation of advanced therapy. The changes will be determined by completion of questionnaires

    Baseline (Day 0), Week 16 and 24 weeks after initiation of advanced therapy

Interventions

This is an observational (non-interventional) registry

Also known as: This is an observational (non-interventional) registry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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 16 (+/- 5 days) and 24 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.

You may qualify if:

  • To be eligible to participate in this study, an individual must meet all the following criteria:
  • 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, 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.

You may not qualify if:

  • 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 PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study. A. Patients currently enrolled in the CorEvitas PSO Registry are ineligible for participation in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study.
  • B. Patients otherwise meeting eligibility criteria can be enrolled in the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment Response Non-Interventional Study C. Following completion or at time of Exit from the PPDTM CorEvitasTM Psoriasis (PSO) Early Treatment 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

RECRUITING

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Registries

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesRecordsOrganization and AdministrationHealth Services AdministrationHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
26 Weeks
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2026

First Posted

June 15, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2036

Study Completion (Estimated)

December 31, 2036

Last Updated

June 15, 2026

Record last verified: 2026-06

Locations