A Study to Describe the Real-world Effectiveness, Safety and Patterns of Use of Dupilumab in Patients With Chronic Spontaneous Urticaria

Sanofi400 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

400

Conditions

Chronic Spontaneous Urticaria

Interventions

Dupilumab

This study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Virtual Research Coordination Center

Wilmington, North Carolina, United States

RECRUITING

Outcomes

Primary Outcomes

Summary of Sociodemographic Characteristics

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.

Time frame: Baseline

Summary of Medical History of Chronic Spontaneous Urticaria (CSU)

Medical history of CSU, including but not limited to CSU status and CSU treatment history will be collected.

Time frame: Baseline

Summary of Type of Baseline Comorbidities

Type of baseline comorbidities including atopic and non-atopic will be collected.

Time frame: Baseline

Summary of Type of Concomitant Medication

Type of concomitant medication will be collected.

Time frame: Baseline

Summary of Healthcare Provider Specialties

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.

Time frame: Baseline

Summary of Dupilumab Dosing Regimen

Summary of dupilumab dosing regimen, duration of treatment, time to discontinuation and other discontinuation details, and treatment modifications/interruptions and reasons will be collected.

Time frame: Baseline

Summary of Treatments Used After Discontinuation

Summary of treatments used after discontinuation will be collected.

Time frame: Baseline

Summary of Participants Re-treated with Dupilumab and Reason

Summary of participants re-treated with dupilumab and reason will be collected.

Time frame: Baseline

Secondary Outcomes

Change from Baseline in Disease Activity

Change from baseline in disease activity as assessed by Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT) scores.

Time frame: Baseline to up to 24 months

Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds

Summary of participants who achieve response thresholds, including onset of response, peak response, recapture response will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.

Time frame: Baseline to up to 24 months

Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds

Summary of participants who achieve disease control thresholds will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.

Time frame: Baseline to up to 24 months

Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab

Durability of response will be assessed by using Urticaria Activity Score over 7 days (UAS7). It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.

Time frame: Baseline to up to 24 months

Dupilumab Treatment Details: Duration of Disease Control

Duration of disease control prior to and after discontinuation of dupilumab will be assessed.

Time frame: Baseline to up to 24 months

Change from Baseline in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) for Adult Participants

The CU-Q2oL is a patient-reported outcome measure designed to assess the impact of chronic urticaria on various aspects of a patient's life. It includes questions that evaluate physical symptoms, emotional well-being, daily activities, sleep quality, and treatment satisfaction. Responses are scored on a 5-point Likert scale, reflecting the overall QoL impairment, with higher scores indicating greater negative impact.

Central Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 Contact-US@sanofi.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Baseline to up to 24 months

Change from Baseline in Dermatology Life Quality Index (DLQI) for Participants 16 years of Age or Older

The DLQI is a 10-question, patient-reported outcome measure designed to assess the impact of skin diseases on the QoL.24 It covers domains such as symptoms, emotional well-being, leisure activities, school performance, personal relationships, and treatment burden. Each question is scored from 0 to 3, with a total score ranging from 0 to 30, where higher scores indicate greater impairment.

Time frame: 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

The CDLQI is a 10-question, patient-reported outcome measure designed to assess the impact of skin diseases on the QoL.24 It covers domains such as symptoms, emotional well-being, leisure activities, school performance, personal relationships, , and treatment burden. Each question is scored from 0 to 3, with a total score ranging from 0 to 30, where higher scores indicate greater impairment.

Time frame: Baseline to up to 24 months

Change from Baseline in Work Productivity and Activity Impairment: Chronic urticaria (WPAI:CU) for Adult Participants

The WPAI:CU is a 6-item PRO instrument that measures the effect of a condition on productivity during work and regular activities in the 7 days prior to completion. The instrument comprises 4 domains: absenteeism, presenteeism, overall work impairment, and activity impairment due to chronic urticaria. WPAI:CU outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.

Time frame: Baseline to up to 24 months

Change from Baseline in Treatment satisfaction (TSQM-9) for Adult Participants

The TSQM-9 is a 9-item PRO measure designed to evaluate satisfaction with medication across 3 domains: effectiveness, side effects, and convenience.27 It uses a 5- or 7-point Likert scale to score responses, which are then transformed to a 0-100 scale, with higher scores indicating greater satisfaction.

Time frame: Baseline to up to 24 months

CSU-related Hospitalization

CSU-related hospitalization including number of hospital visits, number of emergency department visits, number of specialist visits will be collected.

Time frame: Baseline to up to 24 months

Number of Particiapants Experiencing Adverse Events

Number of participants experiencing AEs will be assessed.

Time frame: Baseline to up to 24 months

Number of Participants Experiencing Serious Adverse Events (SAEs)

Number of participants experiencing SAEs will be assessed.

Time frame: Baseline to up to 24 months

Number of Participants Experiencing Adverse Events of Special Interest (AESI)

Number of participants experiencing AESI will be assessed.

Time frame: Baseline to up to 24 months