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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06100991
Other study ID # GPP-510
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 19, 2023
Est. completion date December 2099

Study information

Verified date April 2024
Source CorEvitas
Contact Cathy Cheney
Phone +1 508 408 5433
Email corevitasregistrytrials@corevitas.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 2099
Est. primary completion date December 2099
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States CorEvitas, LLC Waltham Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure:GPP epidemiology, presentation, natural history, management, and outcomes The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation, natural history, management and outcomes Through study completion, an average of 10 years
Secondary Subject Reported - Skin Itch NRS Score: 0-100, with a high score indicating severe skin itch Every 6 months up to 10 years
Secondary Subject Reported - Skin Burning NRS Score: 0-100, with a high score indicating severe skin burning Every 6 months up to 10 years
Secondary 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
Secondary 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
Secondary 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
Secondary Subject Reported - EQ-VAS 0 means worst imaginable health state 100 means best imaginable health state Every 6 months up to 10 years
Secondary 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
Secondary 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
Secondary 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
Secondary Subject Reported - Psoriasis Epidemiology Screening Tool (PEST) This measure is used for screening patients with psoriasis Every 6 months up to 10 years
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Physician Reported - Investigator Global Assessment (IGA) Score: 0-4, with high score indicating widespread of psoriasis Every 6 months up to 10 years
See also
  Status Clinical Trial Phase
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Completed NCT05512598 - HB0034 in Patients With Generalized Pustular Psoriasis (GPP) Phase 1
Active, not recruiting NCT03886246 - Effisayil™ ON: A Study to Test Long-term Treatment With Spesolimab in People With Generalized Pustular Psoriasis Who Took Part in a Previous Study Phase 2
Recruiting NCT05670821 - PMS of Spesolimab I.V. in GPP Patients With Acute Symptoms
Recruiting NCT06323356 - A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Completed NCT05239039 - An Expanded Access Program in China to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Completed NCT04399837 - A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis Phase 2
Not yet recruiting NCT06433531 - A Clinical Study of TQH2929 Injection in Treatment With Generalized Pustular Psoriasis (GPP) Phase 1
Completed NCT03942042 - A Study of Ixekizumab (LY2439821) in Participants in Japan With Generalized Pustular Psoriasis and Erythrodermic Psoriasis Phase 4
Completed NCT06391996 - Biologic Therapy for Generalized Pustular Psoriasis
Completed NCT03782792 - Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis Phase 2
Completed NCT03619902 - A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis Phase 2
Active, not recruiting NCT04566471 - Palmoplantar Pustulosis and Generalized Pustular Psoriasis: A National Population-based Analysis of Prevalence
Recruiting NCT06295692 - A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis Phase 3
Completed NCT05200247 - An Expanded Access Trial in Japan to Provide Spesolimab to People With a Flare-up in Generalized Pustular Psoriasis Who Have no Other Treatment Options Phase 3
Active, not recruiting NCT05366855 - Long-Term Safety and Efficacy of Imsidolimab (ANB019) in Subjects With Generalized Pustular Psoriasis Phase 3
Completed NCT05352893 - Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With GPP Phase 3

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