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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)

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ClinicalTrials.gov Identifier: NCT04180488
Recruitment Status : Active, not recruiting
First Posted : November 27, 2019
Last Update Posted : April 11, 2024
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Study Description
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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


Condition or disease Intervention/treatment Phase
Chronic Spontaneous Urticaria Drug: Dupilumab SAR231893 Drug: Placebo Drug: non sedating H1-antihistamine Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : August 22, 2024
Estimated Study Completion Date : October 24, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Dupilumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study A Dupilumab
dose regimens, on top of non-sedating H1-antihistamine
 Drug: Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Placebo Comparator: Study A Matched Placebo
placebo, on top of non-sedating H1-antihistamine
 Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Experimental: Study B Dupilumab
dose regimens, on top of non-sedating H1-antihistamine
 Drug: Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Placebo Comparator: Study B Matched Placebo
placebo, on top of non-sedating H1-antihistamine
 Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Experimental: Study C Dupilumab
dose regimens, on top of non-sedating H1-antihistamine
 Drug: Dupilumab SAR231893
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration
Placebo Comparator: Study C Matched Placebo
placebo, on top of non-sedating H1-antihistamine
 Drug: Placebo
Pharmaceutical form:Injection solution Route of administration: Subcutaneous

Drug: non sedating H1-antihistamine
Pharmaceutical form:Tablet Route of administration: oral administration


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in weekly itch severity score (except EU and EU reference countries) [ Time Frame: Baseline to Week 24 ]
    Change from baseline in weekly itch severity score (ISS7) at Week 24.

  2. For EU and EU reference countries only: change from baseline in weekly urticaria activity score [ Time Frame: Baseline to Week 24 ]
    Change from baseline in weekly urticaria activity score (UAS7, composite patient reported itch and hive score) at Week 24.


Secondary Outcome Measures :
  1. Change from baseline in weekly urticaria activity score [ Time Frame: Baseline to Week 12 and Week 24 ]
    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).

  2. Change from baseline in ISS7 [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in ISS7 at Week 12 and Week 24 (in EU and EU reference countries).

  3. Change from baseline in weekly hives severity score [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in weekly hives severity score (HSS7) at Week 12 and Week 24.

  4. 4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response [ Time Frame: 4. Baseline over time until Week 24 ]
    4. Time to ISS7 minimally important (MID) (ISS7 ≥5) response.

  5. Proportion of ISS7 MID (≥5 points) responders [ Time Frame: Week 12 and Week 24 ]
    Proportion of ISS7 MID (≥5 points) responders at Week 12 and Week 24.

  6. Change from baseline in ISS7 at all time points [ Time Frame: Baseline to Week 24 ]
    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).

  7. Proportion of patients with UAS7 ≤6 [ Time Frame: Week 12 and Week 24 ]
    Proportion of patients with UAS7 ≤6 at Week 12 and Week 24.

  8. Proportion of patients with UAS7=0 [ Time Frame: Week 12 and Week 24 ]
    Proportion of patients with UAS7=0 at Week 12 and Week 24.

  9. Change from baseline in angioedema activity score over 7 days (AAS7) [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in angioedema activity score over 7 days (AAS7) at Week 12 and Week 24.

  10. Change from baseline in urticaria control test (UCT) [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in urticaria control test (UCT) at Week 12 and Week 24.

  11. Proportion of well controlled patients (UCT ≥12) [ Time Frame: Week 12 and Week 24 ]
    Proportion of well controlled patients (UCT ≥12) at Week 12 and Week 24.

  12. Change from baseline in health-related quality-of-life - DLQI [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in health-related quality-of-life (HRQoL) as measured by Dermatology Life Quality Index (DLQI) in patients ≥16 years old.

  13. Change from baseline in health-related quality-of-life - CDLQI [ Time Frame: Baseline to Week 12 and Week 24 ]
    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.

  14. Patient Global Assessment of Change (PGIC) of CSU [ Time Frame: Week 12 and Week 24 ]
    Patient Global Assessment of Change (PGIC) of CSU at Week 12 and Week 24.

  15. Change from baseline in Patient Global Impression of Severity (PGIS) of CSU [ Time Frame: Baseline to Week 12 and Week 24 ]
    Change from baseline in Patient Global Impression of Severity (PGIS) of CSU at Week 12 and Week 24.

  16. Proportion of patients receiving OCS for CSU during the planned treatment period [ Time Frame: Baseline over time to Week 24 ]
    Proportion of patients receiving OCS for CSU during the planned treatment period.

  17. Time to event of patients receiving OCS for CSU during the planned treatment period [ Time Frame: Baseline over time to Week 24 ]
    Tme to event of patients receiving OCS for CSU during the planned treatment period.

  18. Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs) [ Time Frame: Baseline to Week 24 ]
    Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs).

  19. Incidence of treatment-emergent ADA against dupilumab over time [ Time Frame: Baseline to Week 24 ]
    Incidence of treatment-emergent ADA against dupilumab over time.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04180488


Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
More Information
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT04180488    
Other Study ID Numbers: EFC16461
U1111-1241-8208 ( Registry Identifier: ICTRP )
2019-003775-19 ( EudraCT Number )
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urticaria
Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chronic Disease
Disease Attributes
 Pathologic Processes
Histamine Antagonists
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs