Dupilumab for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine and Who Are na ve to Intolerant of or Incomplete Responders to Omalizumab

  • STATUS
    Recruiting
  • End date
    Apr 17, 2022
  • participants needed
    234
  • sponsor
    Sanofi
Updated on 17 February 2021
corticosteroids
antihistamines
omalizumab
urticaria
dupilumab
h1 antihistamine
angioedema

Summary

Primary Objective:

To demonstrate the efficacy of dupilumab in study participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A: omalizumab nave; Study B: omalizumab intolerant or incomplete responders)

Secondary Objectives:

To demonstrate the efficacy of dupilumab on urticaria activity composite endpoint and itch or hives, separately, at various timepoints To demonstrate the efficacy of dupilumab on angioedema To demonstrate the efficacy of dupilumab on urticaria control To demonstrate improvement in health-related quality of life and overall disease status and severity To evaluate the ability of dupilumab in reducing the proportion of patients who require treatment with oral corticosteroids (OCS) To evaluate safety outcome measures To evaluate immunogenicity of dupilumab

Description

The duration of study for each participant will include 2-4 weeks of screening period, 24 weeks of treatment period and 12 weeks of post treatment period.

Details
Condition Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria
Treatment Placebo, Dupilumab SAR231893, non sedating H1-antihistamine
Clinical Study IdentifierNCT04180488
SponsorSanofi
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 6 yrs and 80 yrs?
Gender: Male or Female
Do you have Chronic Spontaneous Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Idiopathic Urticaria or Chronic Spontaneous Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Spontaneous Urticaria or Chronic Idiopathic Urticaria?
Do you have any of these conditions: Chronic Idiopathic Urticaria or Chronic Spontaneous Urticaria?
Study A: Participant must be 6 years to 80 years of age at the time of signing the informed consent
Study B: Participant must be 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 have 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 this time period
Using a study defined H1-antihistamine for CSU treatment
During the 7 days before randomization
UAS716 ISS7 8
Study A: omalizumab nave, Study B; intolerant or incomplete responder to omalizumab Participants must be willing and able to complete a daily symptom e-Diary for the duration of the study

Exclusion Criteria

Participants are excluded from any of the studies if any of the following
criteria apply
Weight is 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
Presence 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 adversely affect the patient'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 patient's potential participation in a clinical trial
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