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

• Status: Active, not recruiting
• Trial end date: 2022-06-27
• Target enrollment: 0
• Participant gender: All

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 naïve; 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Histamine Antagonists; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Omalizumab

Criteria

Inclusion criteria :

• 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:

UAS7≥16 ISS7≥ 8

o Study A: omalizumab naïve, 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.