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Continuation of TRAVERSE- LTS12551 Evaluating Dupilumab Safety in Patients With Asthma (Long-Term Follow-Up)

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ClinicalTrials.gov Identifier: NCT03620747
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To describe the long-term safety of dupilumab in treatment of patients with moderate to severe asthma who completed the previous asthma clinical trial (TRAVERSE-LTS12551).


Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab SAR231893 (REGN668) Phase 3

Detailed Description:
Duration per participant is until dupilumab approval for use in asthma and market availability to the patient, or a maximum of 144 weeks (ie, about 3 years) after the Start of Treatment (V1), whichever comes first.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label, Interventional, Cohort Study to Evaluate Long-term Safety of Dupilumab in Patients With Moderate to Severe Asthma Who Completed the TRAVERSE-LTS12551 Clinical Trial
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Dupilumab
One dose administered every two weeks. A loading dose may be administered at the start of treatment for some patients (e.g., due to previous Dupilumab treatment discontinuation for more than 6 weeks).
Drug: Dupilumab SAR231893 (REGN668)

Pharmaceutical form: prefilled syringes

Route of administration: subcutaneous





Primary Outcome Measures :
  1. Treatment-emergent adverse events (TEAE) [ Time Frame: Up to 3 years ]
    Percentage of patients reporting any TEAE

  2. TEAE [ Time Frame: Up to 3 years ]
    Event rates per 100 patient-years



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with asthma who completed the treatment period in the previous dupilumab asthma clinical study LTS12551.
  • Signed written informed consent.

Exclusion criteria:

  • Patients who experienced any systemic hypersensitivity reactions to the investigational medicinal product (IMP) in the previous dupilumab asthma study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient.
  • Clinically significant comorbidity/lung disease other than asthma.
  • Patients with active autoimmune disease or patients who, as per Investigator's medical judgment, are suspected of having high risk for developing autoimmune disease.
  • History of malignancy within 5 years before enrollment except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


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): NCT03620747


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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United States, Utah
Investigational Site Nb 840035 Active, not recruiting
Draper, Utah, United States, 84020
United States, Vermont
Investigational site nb 840057 Active, not recruiting
South Burlington, Vermont, United States, 05403
Belgium
Belgium Active, not recruiting
Belgium, Belgium
Canada
CANADA Recruiting
Canada, Canada
France
FRANCE Recruiting
France, France
Germany
GERMANY Recruiting
Germany, Germany
Israel
ISRAEL Active, not recruiting
Israel, Israel
Japan
Japan Active, not recruiting
Japan, Japan
Netherlands
Netherlands Active, not recruiting
Netherlands, Netherlands
South Africa
South Africa Recruiting
South Africa, South Africa
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03620747     History of Changes
Other Study ID Numbers: LPS15023
2017-002134-23 ( EudraCT Number )
U1111-1196-5369 ( Other Identifier: UTN )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs