CorEvitas Generalized Pustular Psoriasis (GPP) Drug Safety and Effectiveness Registry

Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target

Study Overview

• Status: Recruiting
• Conditions: Generalized Pustular Psoriasis

Detailed Description

The objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of GPP for the purposes of clinical, market, or outcomes research.

This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Cathy Cheney; Phone Number: +1 508 408 5433; Email: corevitasregistrytrials@corevitas.com
• Study Contact Backup: Name: Jeffrey Greenberg, MD

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • CorEvitas, LLC
      • Contact: Cathy Cheney; Email: corevitasregistrytrials@corevitas.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects are enrolled in the GPP Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.

Description

Inclusion Criteria:

• A subject must meet all the following criteria to participate in the registry:

  1. Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner.
  2. Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
  3. Is willing to provide consent for participation in the registry.
  4. Is willing to provide Personal Information

Exclusion Criteria:

• Any of the following would exclude the subject from participating in the registry:

  1. Is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.
  2. Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Generalized Pustular Psoriasis (GPP); Pts presenting to enrolling sites across the North America are invited to enroll if eligible

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome Measure:GPP epidemiology and Presentation	The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation and natural history.	Through study completion, an average of 10 years
GPP management, and outcomes	The major clinical outcome include an assessment of the epidemiology of GPP; to better understand the management and outcomes.	Through study completion, an average of 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Reported - European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)	This measure determines the health of the subject by answering questions related to mobility, self care,anxiety. depression	Every 6 months up to 10 years
Subject Reported - EQ-VAS	0 means worst imaginable health state 100 means best imaginable health state	Every 6 months up to 10 years
Subject Reported - World Health Organization Five Well-Being Index (WHO-5)	This measure determines how you have been feeling over the last two weeks.	Every 6 months up to 10 years
Subject Reported - Work Productivity and Activity Impairment (WPAI)	This measure determines the effect of your health problems on your ability to work and perform regular activities	Every 6 months up to 10 years
Subject Reported - Audit C	It is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders	Every 6 months up to 10 years
Subject Reported - Psoriasis Epidemiology Screening Tool (PEST)	This measure is used for screening patients with psoriasis	Every 6 months up to 10 years
Subject Reported - Dermatology Life Quality Index (DLQI)	This measure determines how much your skin problem has affected your life in past one week	Every 6 months up to 10 years
Subject Reported - Pain VAS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Physician Reported - Generalized Pustular Psoriasis Physician Global Assessment (GPPGA)	This tool is used is used for the assessment of disease severity, specifically designed for GPP	Every 6 months up to 10 years
Physician Reported - Generalized Pustular Psoriasis Area Severity Index (GPPASI)	This tool is used is used for the assessment of disease severity, specifically designed for GPP	Every 6 months up to 10 years
Physician Reported - Investigator Global Assessment (IGA)	Score: 0-4, with high score indicating widespread of psoriasis	Every 6 months up to 10 years
Subject Reported - Skin Itch NRS	Score: 0-100, with a high score indicating severe skin itch	Every 6 months up to 10 years
Subject Reported - Skin Burning NRS	Score: 0-100, with a high score indicating severe skin burning	Every 6 months up to 10 years
Subject Reported - Fatigue NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Subject Reported - Joint Pain NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild pain higher numbers are for severe pain	Every 6 months up to 10 years
Subject Reported - Generalized Pustular Psoriasis Numeric Rating Scale (NRS)	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild GPP higher numbers are for severe GPP	Every 6 months up to 10 years
Subject Reported - Plaque Psoriasis NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild plaque psoriasis higher numbers are for severe plaque psoriasis	Every 6 months up to 10 years
Subject Reported - Psoriatic Arthritis NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild psoriatic arthritis higher numbers are for severe psoriatic arthritis	Every 6 months up to 10 years
Subject Reported - Skin Pain NRS	Score: 0-100, None- 0 , 100, Severe. Lower numbers are for mild skin pain higher numbers are for severe skin pain	Every 6 months up to 10 years

Collaborators and Investigators

• Sponsor: CorEvitas

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): December 1, 2099
• Study Completion (Estimated): December 1, 2099

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: GPP-510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No