A Prospective Observational Study of Patients Receiving Dupilumab for Chronic Spontaneous Urticaria
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Sanofi
- Enrollment
- 1
- Locations
- 2
- Primary Endpoint
- Summary of Sociodemographic Characteristics
Study Overview
Brief Summary
This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU). This study will be conducted in the United States and will collect data available from participants' medical files, other items routinely collected during disease management in clinical practice, and patient-reported outcomes related to disease, work productivity, quality of life, and CSU-related hospitalizations.
Participation in this study is the patient's own choice and is entirely voluntary. The treating physician prescribes dupilumab treatment as part of routine care, independently of the study. Once the decision to prescribe dupilumab is made by the treating physician, patients can self-screen and will be contacted by the Virtual Research Coordination Center to determine potential study eligibility. Patients will be enrolled if they provide an informed consent and meet all inclusion criteria and none of the exclusion criteria.
The duration of the study for each participant is 24 months. All patients will be followed for 24 months or until death, loss to follow-up, or withdrawal, whichever occurs first.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 12 years or older at the time of informed consent/assent.
- •Physician decision to treat the patient with dupilumab for chronic spontaneous urticaria (CSU) made prior to and independently of the patient's participation in the study.
- •Patient is able to understand and complete study-related questionnaires.
- •Patients and/or parent/legally authorized representative provide voluntary informed consent and/or assent to participate in the study before inclusion in the study.
Exclusion Criteria
- •Patients who have a contraindication to dupilumab according to the approved prescribing information label.
- •Any condition that the treating physician or virtual Investigator believes may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments.
- •Patients currently participating in any interventional clinical trial.
- •Prior use of dupilumab within 6 months of the baseline assessment.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Outcomes
Primary Outcomes
Summary of Sociodemographic Characteristics
Time Frame: Baseline
Sociodemographic and clinical characteristics, including but not limited to month and year of birth, age, sex, race, ethnicity, IgE levels, employment status, height, weight, and smoking status will be collected.
Summary of Medical History of Chronic Spontaneous Urticaria (CSU)
Time Frame: Baseline
Medical history of CSU, including but not limited to CSU status and CSU treatment history will be collected.
Summary of Type of Baseline Comorbidities
Time Frame: Baseline
Type of baseline comorbidities including atopic and non-atopic will be collected.
Summary of Type of Concomitant Medication
Time Frame: Baseline
Type of concomitant medication will be collected.
Summary of Healthcare Provider Specialties
Time Frame: Baseline
Healthcare practitioner's information (related to CSU treatment) and specialty (example, dermatology physician, dermatology nurse practitioner, dermatology physician assistant, allergy/immunology physician, allergy/immunology nurse practitioner, allergy/immunology physician assistant) will be collected.
Summary of Dupilumab Dosing Regimen
Time Frame: Baseline
Summary of dupilumab dosing regimen, duration of treatment, time to discontinuation and other discontinuation details, and treatment modifications/interruptions and reasons will be collected.
Summary of Treatments Used After Discontinuation
Time Frame: Baseline
Summary of treatments used after discontinuation will be collected.
Summary of Participants Re-treated with Dupilumab and Reason
Time Frame: Baseline
Summary of participants re-treated with dupilumab and reason will be collected.
Secondary Outcomes
- Change from Baseline in Disease Activity(Baseline to up to 24 months)
- Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds(Baseline to up to 24 months)
- Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds(Baseline to up to 24 months)
- Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab(Baseline to up to 24 months)
- Dupilumab Treatment Details: Duration of Disease Control(Baseline to up to 24 months)
- Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Adult Participants(Baseline to up to 24 months)
- Change from Baseline in Dermatology Life Quality Index (DLQI) for Participants 16 years of Age or Older(Baseline to up to 24 months)
- Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) for Participants 15 Years of Age or Younger(Baseline to up to 24 months)
- Change from Baseline in Work Productivity and Activity Impairment: Chronic urticaria (WPAI:CU) for Adult Participants(Baseline to up to 24 months)
- Change from Baseline in Treatment satisfaction (TSQM-9) for Adult Participants(Baseline to up to 24 months)
- CSU-related Hospitalization(Baseline to up to 24 months)
- Number of Particiapants Experiencing Adverse Events(Baseline to up to 24 months)
- Number of Participants Experiencing Serious Adverse Events (SAEs)(Baseline to up to 24 months)
- Number of Participants Experiencing Adverse Events of Special Interest (AESI)(Baseline to up to 24 months)