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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)

Primary Purpose

Chronic Spontaneous Urticaria

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dupilumab SAR231893
Placebo
non sedating H1-antihistamine
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Spontaneous Urticaria

Eligibility Criteria

6 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Study A and C: 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

  • Study A and C: 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.

Sites / Locations

  • California Allergy and Asthma Medical Group, Inc.-Site Number:8400019
  • Sarasota Clinical Research-Site Number:8400017
  • Lenus Research & Medical Group-Site Number:8400001
  • University of South Florida-Site Number:8400006
  • Aeroallergy Research Laboratories of Savannah, INC-Site Number:8400018
  • Allergy & Asthma Specialists, PSC-Site Number:8400020
  • Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400016
  • The Clinical Research Center, LLC-Site Number:8400009
  • UR Dermatology at College Town-Site Number:8400008
  • Immunocarolina LLC-Site Number:8400010
  • Bernstein Clinical Research Center-Site Number:8400014
  • Vital Prospects Clinical Research Institute, P.C.-Site Number:8400015
  • National Allergy and ENT-Site Number:8400011
  • Pharmaceutical Research & Consulting, Inc.-Site Number:8400003
  • STAAMP Research, LLC-Site Number:8400007
  • Investigational Site Number :0320008
  • Investigational Site Number :0320004
  • Investigational Site Number :0320006
  • Investigational Site Number :0320007
  • Investigational Site Number :0320005
  • Investigational Site Number :0320003
  • Investigational Site Number :0320001
  • Investigational Site Number :1240009
  • Investigational Site Number :1240010Recruiting
  • Investigational Site Number :1240014Recruiting
  • Investigational Site Number :1240013Recruiting
  • Investigational Site Number :1240003Recruiting
  • Investigational Site Number :1240005Recruiting
  • Investigational Site Number :1240002Recruiting
  • Investigational Site Number :1240007Recruiting
  • Investigational Site Number :1240016Recruiting
  • Investigational Site Number :1240006Recruiting
  • Investigational Site Number :1240015Recruiting
  • Investigational Site Number :1240004Recruiting
  • Investigational Site Number :1240011Recruiting
  • Investigational Site Number :1560010Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560007
  • Investigational Site Number :1560002Recruiting
  • Investigational Site Number :1560008Recruiting
  • Investigational Site Number :1560006Recruiting
  • Investigational Site Number :1560003Recruiting
  • Investigational Site Number :1560005Recruiting
  • Investigational Site Number :2500008Recruiting
  • Investigational Site Number :2500002Recruiting
  • Investigational Site Number :2500004Recruiting
  • Investigational Site Number :2500003
  • Investigational Site Number :2500006Recruiting
  • Investigational Site Number :2500005Recruiting
  • Investigational Site Number :2500007Recruiting
  • Investigational Site Number :2760001Recruiting
  • Investigational Site Number :2760006Recruiting
  • Investigational Site Number :2760007
  • Investigational Site Number :2760011Recruiting
  • Investigational Site Number :2760008Recruiting
  • Investigational Site Number :3480005
  • Investigational Site Number :3480004Recruiting
  • Investigational Site Number :3480003Recruiting
  • Investigational Site Number :3480002Recruiting
  • Investigational Site Number :3920004
  • Investigational Site Number :3920005
  • Investigational Site Number :3920009Recruiting
  • Investigational Site Number :3920002
  • Investigational Site Number :3920011Recruiting
  • Investigational Site Number :3920008Recruiting
  • Investigational Site Number :3920003
  • Investigational Site Number :3920007Recruiting
  • Investigational Site Number :3920006Recruiting
  • Investigational Site Number :3920001Recruiting
  • Investigational Site Number :3920010Recruiting
  • Investigational Site Number :6430008
  • Investigational Site Number :6430006
  • Investigational Site Number :6430007
  • Investigational Site Number :6430005
  • Investigational Site Number :6430010
  • Investigational Site Number :6430002
  • Investigational Site Number :6430009
  • Investigational Site Number :6430004
  • Investigational Site Number :6430003
  • Investigational Site Number :6430001
  • Investigational Site Number :7240012Recruiting
  • Investigational Site Number :7240003Recruiting
  • Investigational Site Number :7240008Recruiting
  • Investigational Site Number :7240014Recruiting
  • Investigational Site Number :7240010Recruiting
  • Investigational Site Number :7240005
  • Investigational Site Number :7240007
  • Investigational Site Number :7240001Recruiting
  • Investigational Site Number :7240006Recruiting
  • Investigational Site Number :7240002
  • Investigational Site Number :7240013Recruiting
  • Investigational Site Number :7240004
  • Investigational Site Number :7240009Recruiting
  • Investigational Site Number :7240011Recruiting
  • Investigational Site Number :8260002
  • Investigational Site Number :8260001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Study A Dupilumab

Study A Matched Placebo

Study B Dupilumab

Study B Matched Placebo

Study C Dupilumab

Study C Matched Placebo

Arm Description

dose regimens, on top of non-sedating H1-antihistamine

placebo, on top of non-sedating H1-antihistamine

dose regimens, on top of non-sedating H1-antihistamine

placebo, on top of non-sedating H1-antihistamine

dose regimens, on top of non-sedating H1-antihistamine

placebo, on top of non-sedating H1-antihistamine

Outcomes

Primary Outcome Measures

Change from baseline in weekly itch severity score (except EU and EU reference countries)
Change from baseline in weekly itch severity score (ISS7) at Week 24.
For EU and EU reference countries only: change from baseline in weekly urticaria activity score
Change from baseline in weekly urticaria activity score (UAS7, composite patient reported itch and hive score) at Week 24.

Secondary Outcome Measures

Change from baseline in weekly urticaria activity score
Change from baseline in weekly urticaria activity score (UAS7, composite patient reported itch and hive score) at Week 12 and Week 24 (except EU and EU reference countries).
Change from baseline in ISS7
Change from baseline in ISS7 at Week 12 and Week 24 (in EU and EU reference countries).
Change from baseline in weekly hives severity score
Change from baseline in weekly hives severity score (HSS7) at Week 12 and Week 24.
4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response
4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response.
Proportion of ISS7 MID (≥5 points) responders
Proportion of ISS7 MID (≥5 points) responders at Week 12 and Week 24.
Change from baseline in ISS7 at all time points
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).
Proportion of patients with UAS7 ≤6
Proportion of patients with UAS7 ≤6 at Week 12 and Week 24.
Proportion of patients with UAS7=0
Proportion of patients with UAS7=0 at Week 12 and Week 24.
Change from baseline in angioedema activity score over 7 days (AAS7)
Change from baseline in angioedema activity score over 7 days (AAS7) at Week 12 and Week 24.
Change from baseline in urticaria control test (UCT)
Change from baseline in urticaria control test (UCT) at Week 12 and Week 24.
Proportion of well controlled patients (UCT ≥12)
Proportion of well controlled patients (UCT ≥12) at Week 12 and Week 24.
Change from baseline in health-related quality-of-life - DLQI
Change from baseline in health-related quality-of-life (HRQoL) as measured by Dermatology Life Quality Index (DLQI) in patients ≥16 years old.
Change from baseline in health-related quality-of-life - CDLQI
Change from baseline in health-related quality-of-life (HRQoL) as measured by Children's Dermatology Life Quality Index (CDLQI) in patients ≥6 - <16 years old at Week 12 and Week 24.
Patient Global Assessment of Change (PGIC) of CSU
Patient Global Assessment of Change (PGIC) of CSU at Week 12 and Week 24.
Change from baseline in Patient Global Impression of Severity (PGIS) of CSU
Change from baseline in Patient Global Impression of Severity (PGIS) of CSU at Week 12 and Week 24.
Proportion of patients receiving OCS for CSU during the planned treatment period
Proportion of patients receiving OCS for CSU during the planned treatment period.
Time to event of patients receiving OCS for CSU during the planned treatment period
Tme to event of patients receiving OCS for CSU during the planned treatment period.
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).
Incidence of treatment-emergent ADA against dupilumab over time
Incidence of treatment-emergent ADA against dupilumab over time.

Full Information

First Posted
November 25, 2019
Last Updated
September 21, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04180488
Brief Title
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)
Official Title
Master Protocol of Three Randomized, Double-blind, Placebo Controlled, Multi-center, Parallel-group Studies of Dupilumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite the Use of H1 Antihistamine Treatment in Patients naïve to Omalizumab and in Patients Who Are Intolerant or Incomplete Responders to Omalizumab
Study Type
Interventional

2. Study Status

Record Verification Date
September 21, 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
March 15, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 and C: 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
Detailed 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. Study C will recruit in US if required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spontaneous Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study A Dupilumab
Arm Type
Experimental
Arm Description
dose regimens, on top of non-sedating H1-antihistamine
Arm Title
Study A Matched Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, on top of non-sedating H1-antihistamine
Arm Title
Study B Dupilumab
Arm Type
Experimental
Arm Description
dose regimens, on top of non-sedating H1-antihistamine
Arm Title
Study B Matched Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, on top of non-sedating H1-antihistamine
Arm Title
Study C Dupilumab
Arm Type
Experimental
Arm Description
dose regimens, on top of non-sedating H1-antihistamine
Arm Title
Study C Matched Placebo
Arm Type
Placebo Comparator
Arm Description
placebo, on top of non-sedating H1-antihistamine
Intervention Type
Drug
Intervention Name(s)
Dupilumab SAR231893
Intervention Description
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form:Injection solution Route of administration: Subcutaneous
Intervention Type
Drug
Intervention Name(s)
non sedating H1-antihistamine
Intervention Description
Pharmaceutical form:Tablet Route of administration: oral administration
Primary Outcome Measure Information:
Title
Change from baseline in weekly itch severity score (except EU and EU reference countries)
Description
Change from baseline in weekly itch severity score (ISS7) at Week 24.
Time Frame
Baseline to Week 24
Title
For EU and EU reference countries only: change from baseline in weekly urticaria activity score
Description
Change from baseline in weekly urticaria activity score (UAS7, composite patient reported itch and hive score) at Week 24.
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Change from baseline in weekly urticaria activity score
Description
Change from baseline in weekly urticaria activity score (UAS7, composite patient reported itch and hive score) at Week 12 and Week 24 (except EU and EU reference countries).
Time Frame
Baseline to Week 12 and Week 24
Title
Change from baseline in ISS7
Description
Change from baseline in ISS7 at Week 12 and Week 24 (in EU and EU reference countries).
Time Frame
Baseline to Week 12 and Week 24
Title
Change from baseline in weekly hives severity score
Description
Change from baseline in weekly hives severity score (HSS7) at Week 12 and Week 24.
Time Frame
Baseline to Week 12 and Week 24
Title
4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response
Description
4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response.
Time Frame
4. Baseline over time until Week 24
Title
Proportion of ISS7 MID (≥5 points) responders
Description
Proportion of ISS7 MID (≥5 points) responders at Week 12 and Week 24.
Time Frame
Week 12 and Week 24
Title
Change from baseline in ISS7 at all time points
Description
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).
Time Frame
Baseline to Week 24
Title
Proportion of patients with UAS7 ≤6
Description
Proportion of patients with UAS7 ≤6 at Week 12 and Week 24.
Time Frame
Week 12 and Week 24
Title
Proportion of patients with UAS7=0
Description
Proportion of patients with UAS7=0 at Week 12 and Week 24.
Time Frame
Week 12 and Week 24
Title
Change from baseline in angioedema activity score over 7 days (AAS7)
Description
Change from baseline in angioedema activity score over 7 days (AAS7) at Week 12 and Week 24.
Time Frame
Baseline to Week 12 and Week 24
Title
Change from baseline in urticaria control test (UCT)
Description
Change from baseline in urticaria control test (UCT) at Week 12 and Week 24.
Time Frame
Baseline to Week 12 and Week 24
Title
Proportion of well controlled patients (UCT ≥12)
Description
Proportion of well controlled patients (UCT ≥12) at Week 12 and Week 24.
Time Frame
Week 12 and Week 24
Title
Change from baseline in health-related quality-of-life - DLQI
Description
Change from baseline in health-related quality-of-life (HRQoL) as measured by Dermatology Life Quality Index (DLQI) in patients ≥16 years old.
Time Frame
Baseline to Week 12 and Week 24
Title
Change from baseline in health-related quality-of-life - CDLQI
Description
Change from baseline in health-related quality-of-life (HRQoL) as measured by Children's Dermatology Life Quality Index (CDLQI) in patients ≥6 - <16 years old at Week 12 and Week 24.
Time Frame
Baseline to Week 12 and Week 24
Title
Patient Global Assessment of Change (PGIC) of CSU
Description
Patient Global Assessment of Change (PGIC) of CSU at Week 12 and Week 24.
Time Frame
Week 12 and Week 24
Title
Change from baseline in Patient Global Impression of Severity (PGIS) of CSU
Description
Change from baseline in Patient Global Impression of Severity (PGIS) of CSU at Week 12 and Week 24.
Time Frame
Baseline to Week 12 and Week 24
Title
Proportion of patients receiving OCS for CSU during the planned treatment period
Description
Proportion of patients receiving OCS for CSU during the planned treatment period.
Time Frame
Baseline over time to Week 24
Title
Time to event of patients receiving OCS for CSU during the planned treatment period
Description
Tme to event of patients receiving OCS for CSU during the planned treatment period.
Time Frame
Baseline over time to Week 24
Title
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)
Description
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).
Time Frame
Baseline to Week 24
Title
Incidence of treatment-emergent ADA against dupilumab over time
Description
Incidence of treatment-emergent ADA against dupilumab over time.
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Study A and C: 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 Study A and C: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
California Allergy and Asthma Medical Group, Inc.-Site Number:8400019
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Completed
Facility Name
Sarasota Clinical Research-Site Number:8400017
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Completed
Facility Name
Lenus Research & Medical Group-Site Number:8400001
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Completed
Facility Name
University of South Florida-Site Number:8400006
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Completed
Facility Name
Aeroallergy Research Laboratories of Savannah, INC-Site Number:8400018
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Completed
Facility Name
Allergy & Asthma Specialists, PSC-Site Number:8400020
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Individual Site Status
Completed
Facility Name
Johns Hopkins University (Asthma and Allergy Center)-Site Number:8400016
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Completed
Facility Name
The Clinical Research Center, LLC-Site Number:8400009
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
UR Dermatology at College Town-Site Number:8400008
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Completed
Facility Name
Immunocarolina LLC-Site Number:8400010
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Completed
Facility Name
Bernstein Clinical Research Center-Site Number:8400014
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Completed
Facility Name
Vital Prospects Clinical Research Institute, P.C.-Site Number:8400015
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Individual Site Status
Completed
Facility Name
National Allergy and ENT-Site Number:8400011
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Individual Site Status
Completed
Facility Name
Pharmaceutical Research & Consulting, Inc.-Site Number:8400003
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Completed
Facility Name
STAAMP Research, LLC-Site Number:8400007
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Completed
Facility Name
Investigational Site Number :0320008
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Completed
Facility Name
Investigational Site Number :0320004
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Completed
Facility Name
Investigational Site Number :0320006
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0320007
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000BRH
Country
Argentina
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0320005
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Individual Site Status
Completed
Facility Name
Investigational Site Number :0320003
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Completed
Facility Name
Investigational Site Number :0320001
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Completed
Facility Name
Investigational Site Number :1240009
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2J 7E1
Country
Canada
Individual Site Status
Completed
Facility Name
Investigational Site Number :1240010
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240014
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 3C3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240013
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2H 1H5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240005
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3B 3S6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240002
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240007
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 2G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240016
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1G 1X9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240006
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240015
City
Verdun
State/Province
Quebec
ZIP/Postal Code
H4G 3E7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240011
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Beijing
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560007
City
Guangzhou
ZIP/Postal Code
510630
Country
China
Individual Site Status
Completed
Facility Name
Investigational Site Number :1560002
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560008
City
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560005
City
Wuxi
ZIP/Postal Code
214002
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500008
City
Ars-Laquenexy
ZIP/Postal Code
57085
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500004
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Completed
Facility Name
Investigational Site Number :2500006
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500005
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500007
City
Valence
ZIP/Postal Code
26953
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760006
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760007
City
Kiel
ZIP/Postal Code
24148
Country
Germany
Individual Site Status
Completed
Facility Name
Investigational Site Number :2760011
City
Langenau
ZIP/Postal Code
89129
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760008
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480005
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Completed
Facility Name
Investigational Site Number :3480004
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480002
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
454-8509
Country
Japan
Individual Site Status
Completed
Facility Name
Investigational Site Number :3920005
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Individual Site Status
Completed
Facility Name
Investigational Site Number :3920009
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0807
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0017
Country
Japan
Individual Site Status
Completed
Facility Name
Investigational Site Number :3920011
City
Kagoshima-Shi
State/Province
Kagoshima
ZIP/Postal Code
890-0063
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
236-0004
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Individual Site Status
Completed
Facility Name
Investigational Site Number :3920007
City
Izumo-shi
State/Province
Shimane
ZIP/Postal Code
693-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Shinagawa-Ku
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0023
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430008
City
Chelyabinsk
ZIP/Postal Code
454048
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430006
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430007
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430010
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430009
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430004
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430003
City
St-Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430001
City
Stavropol
ZIP/Postal Code
355030
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240012
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240014
City
Hospitalet de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240010
City
Esplugues de Llobregat
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240005
City
Las Palmas de Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240007
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240001
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240013
City
Burjassot - Valencia
State/Province
Valenciana, Comunidad
ZIP/Postal Code
46100
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Completed
Facility Name
Investigational Site Number :7240009
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240011
City
Villareal
ZIP/Postal Code
12540
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260002
City
London
State/Province
London, City Of
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Individual Site Status
Completed
Facility Name
Investigational Site Number :8260001
City
Manchester
ZIP/Postal Code
M23 9QZ,
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Links:
URL
https://www.csutrial.com/
Description
EFC16461 Chronic Urticarial Pruritus Itch Dupilumab Trial website

Learn more about this trial

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)

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