Chronic spontaneous urticaria MedDRA version: 20.0 Level: PT Classification code 10072757 Term: Chronic spontaneous urticaria System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Dupilumab
Product Code: SAR231893
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Dupilumab
Current Sponsor code: SAR231893
Other descriptive name:
Sponsors
Sanofi-aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Must be 12 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 • In-clinic UAS> 4 prior to randomization • Study A: omalizumab naïve, Study B; intolerant or incomplete responder to omalizumab - Participants must be willing and able to complete a daily symptom eDiary for the duration of the study Are the trial subjects under 18? yes Number of subjects for this age range: 12 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 204 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: Participants are excluded from any of the studies if any of the following criteria apply: - Weight is less than 30 kg - 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 - 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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of dupilumab in adult and adolescent participants with CSU who remain symptomatic despite the use of H1 antihistamine (Study A: omalizumab naïve; Study B: omalizumab intolerant or incomplete responders);Secondary Objective: - 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;Primary end point(s): Change from baseline in weekly itch severity score ; Change from baseline in weekly itch severity score (ISS7) at Week 24 ;Timepoint(s) of evaluation of this end point: Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 - 2 - Change from baseline in weekly itch severity score (ISS7) at Week 12 and 24 / Change from baseline in weekly hives severity score (HSS7) at Week 12 and Week 24 ; The hives severity score will be recorded daily in the patient eDiary, on a scale of 0 (none) to 3 (severe). The baseline weekly hive score is the sum of the daily hives scores over the 7 days prior to randomization (Day 1 visit), and the weekly ihives score at Weekk12/ Week 24 is the sum of daily hives scores over the 7 days prior to the Week 12/ Week 24 visit. 3 - Time to ISS7 minimally important (MID) (ISS7 =5) response ; The itch severity score will be recorded daily in the patient eDiary, on a scale of 0 (none) to 3 (severe).The weekly itch score is the sum of the daily itch scores over 7 days 4 - Proportion of ISS7 MID (=5 points) responders at Week 12 and Week 24 ; The itch severity score will be recorded daily in the patient eDiary, on a scale of 0 (none) to 3 (severe).The weekly itch score is the sum of the daily itch scores over 7 days. 5 - Change from baseline in ISS7 at all time points (onset of action is assessed by the first p<0.05 that remains significant at subsequent measures until Week 24 ; The itch severity score will be recorded daily in the patient eDiary, on a scale of 0 (none) to 3 (severe).The weekly itch score is the sum of the daily itch scores over 7 days 6 - Change from baseline in UAS7 at Week 12 ; The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0=none to 3=intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch measured daily. UAS7 is the sum of the daily UAS scores over 7 days. 7 - 8 - Proportion of patients with UAS7 =6 at Week 12 and Week 24 / Proportion of patients with UAS7=0 at Week 12 and Week 24 ; The UAS is a composite eDiary-recorded score with numeric severity intensity ratings on a scale of 0-3 (0=none to 3=intense/severe) for 1) the number of whe | — |
Countries
Argentina, Canada, China, France, Germany, Hungary, Japan, Russian Federation, Spain, United Kingdom, United States
Contacts
Public ContactDirection des Opérations Cliniques
Sanofi-aventis France
Outcome results
None listed