Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are naïve to, Intolerant of, or Incomplete Responders to Omalizumab (LIBERTY-CSU CUPID)
Study of Investigational Medication for Chronic Spontaneous Urticaria
Study Overview
Primary Objective:
This study aimed to demonstrate the efficacy of dupilumab in study participants with CSU who remained symptomatic despite the use of H1 antihistamine (Study A and C: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders)
Secondary Objectives:
This study aimed to demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints This study aimed to demonstrate the efficacy of dupilumab on angioedema This study aimed to demonstrate the efficacy of dupilumab on urticaria control This study aimed to demonstrate improvement in health-related quality of life and overall disease status and severity This study aimed to evaluate the ability of dupilumab in reducing the proportion of participants who require treatment with oral corticosteroids (OCS) This study aimed to evaluate safety outcome measures This study aimed to evaluate immunogenicity of dupilumab
Study Details
The duration of study for each participant included 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Spontaneous Urticaria
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Age: 6 years - 80 years
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Gender: All
Inclusion Criteria:
- Study A and C: Participant were ≥6 years to 80 years of age at the time of signing the informed consent.
- Study B: Participant were ≥12 years (or the minimum legal age for adolescents in the country of the investigational site) to 80 years of age at the time of signing the informed consent
- Participants who had a diagnosis of CSU refractory to H1 antihistamines (H1-AH) at the time of randomization defined by
- Diagnosis of CSU>6 months prior to screening visit
- Presence of itch and hives for >6 consecutive weeks at any time prior to screening visit despite the use of H1-AH during that time period
- Used a study defined H1-antihistamine for CSU treatment
- During the 7 days before randomization:
UAS7≥16 ISS7≥ 8
- Study A and C: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab
- Participants were willing and able to complete a daily symptom e-Diary for the duration of the study
Exclusion Criteria:
Participants were excluded from any of the studies if any of the following criteria apply:
- Weight was less than 30 kg in adults and adolescents and 15 kg in children aged 6 to<12years
- Clearly defined underlying etiology for chronic urticarias other than CSU
- Presented of skin morbidities other than CSU that may interfere with the assessment of the study outcomes
- Active atopic dermatitis
- Severe concomitant illness(es) that, in the investigator's judgment, would have adversely affected the participant's participation in the study
- Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
- Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the screening visit and during the screening period
- Known or suspected immunodeficiency
- Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin
- History of systemic hypersensitivity or anaphylaxis to omalizumab or any biologic therapy, including any excipients
- Participation in prior dupilumab clinical study, or have been treated with commercially available dupilumab.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
This study investigates the use of an investigational medication in patients with Chronic Spontaneous Urticaria (CSU) who continue to experience symptoms despite using H1 antihistamines. The purpose of this study is to evaluate the effectiveness of the investigational medication in different study arms, including those who have not previously tried omalizumab, those intolerant to it, and those who did not fully respond to it.
Participants will undergo various procedures, including assessments of urticaria activity, itch, hives, and angioedema. The study will also evaluate health-related quality of life and the need for oral corticosteroids. Safety and immunogenicity of the investigational medication will be monitored. Participants will be required to complete a daily symptom e-Diary to track their progress.
- Who can participate: Participants aged 6 to 80 years with a diagnosis of CSU, refractory to H1 antihistamines, and meeting specific urticaria activity scores may be eligible. Key factors include being omalizumab naïve, intolerant, or incomplete responders, and willingness to complete a daily e-Diary.
- Study details: Participants will take the investigational medication and record their symptoms daily using an e-Diary. The study will assess the medication's impact on urticaria symptoms and overall health.
- Study timelines: The study will last a total of 38 to 40 weeks per participant.
