Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Overview
- Phase
- Phase 3
- Intervention
- Dupilumab
- Conditions
- Asthma
- Sponsor
- Sanofi
- Enrollment
- 2282
- Locations
- 365
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
Primary Objective:
To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691).
Secondary Objectives:
To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study.
To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to:
- Systemic exposure
- Anti-drug antibodies
- Biomarkers
Detailed Description
A screening period, up to 3 weeks, applied only for participants who came from DRI12544 study. The total study duration, per participant, was a maximum of 108 weeks (or 111 weeks considering a maximum screening period of 3 weeks for study DRI12544) for the participants enrolled prior to Amendment 04 approval and a maximum of 60 weeks for the participants enrolled after Amendment 04 approval. Following amendment 04 (dated 31 Oct 2016) the open-label treatment duration was amended to 48 weeks (1 year); and the 16-week post-treatment period was shortened to 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
dupilumab treatment
For participants coming from the DRI12544 study: dupilumab loading dose subcutaneous (SC) on Day 1, followed by 1\* Dose every 2 weeks added to current controller medications. For participants coming from other studies: dupilumab 1 \* Dose SC every 2 weeks added to current controller medications.
Intervention: Dupilumab
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks)
An Adverse Event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment emergent AE period (time from first dose of investigational medicinal product \[IMP\] in LTS12551 up to the last dose of dupilumab plus 14 weeks). A Serious AE (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.
Secondary Outcomes
- Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities During the TEAE Period(From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks))
- Change From Baseline in Percent Predicted FEV1 at Weeks 48 and 96(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Weeks 48 and 96(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters (Red Blood Cells [RBCs], Platelets and Coagulation) During the TEAE Period(From the first IMP injection in LTS12551 to the last IMP injection plus 14 weeks (up to 108 weeks))
- Number of Severe Exacerbation Events(From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks))
- Annualized Event Rate Per Participant-Years for Severe Exacerbation(From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks))
- Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 48 and 96(Baseline of parent study, Week 48, and Week 96 of this extension study)
- Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Mean Scores at Weeks 24 and 48(Baseline of parent study, Weeks 24, and 48 of this extension study)
- Percentage of Participants Achieving AQLQ Global Score Response (AQLQ Responders) at Weeks 24 and 48(At Weeks 24, and 48 of this extension study)
- Change From Baseline in Forced Vital Capacity (FVC) at Weeks 48 and 96(Baseline of parent study, Week 48, and Week 96 of this extension study)
- Change From Baseline in Evening Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48, and Week 96 of this extension study)
- Change From Baseline in EQ-5D-3L VAS Scores at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Percentage of Participants Achieving ACQ-5 Score Response (ACQ-5 Responders) at Weeks 24 and 48(At Weeks 24, and 48 of this extension study)
- Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Scores at Weeks 24 and 48(Baseline of parent study, Weeks 24, and 48 of this extension study)
- Percentage of Participants With Antidrug Antibodies (ADA) Response(From the first IMP injection in LTS12551 to the last IMP injection plus 2 weeks (up to 96 weeks))
- Change From Baseline in Number of Nocturnal Awakenings at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Percent Change From Baseline in Oral Corticosteroid (OCS) Dose at Weeks 48, and 96: Participants From Study EFC13691(Baseline of parent study, Weeks 48 and 96 of this extension study)
- Serum Concentrations of Dupilumab Over Time Till Week 96(Baseline of parent study, Weeks 0, 4, 12, 24, 48, 72, and 96 of this extension study)
- Change From Baseline in Blood Eosinophils Cells Count at Weeks 48 and 96(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Change From Baseline in Morning Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Percentage of Participants Achieving a Reduction of 50% or Greater (≥ 50% ) in OCS Dose Over Time at Weeks 48 and 96: Participants From Study EFC13691(Weeks 48 and 96 of this extension study)
- Change From Baseline in Evening Peak Expiratory Flow (PEF) at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Change From Baseline in European-Quality of Life-5 Dimension Instrument-3 Levels (EQ-5D-3L) Index Scores at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Change From Baseline in Morning Asthma Symptom Scores at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48 and Week 96 of this extension study)
- Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol for Symptom Relief at Weeks 48 and 96: Participants From Study DRI12544(Baseline of parent study, Week 48, and Week 96 of this extension study)
- Percentage of Participants With Background OCS Completely Tapered Off Over Time at Weeks 48 and 96: Participants From Study EFC13691(Weeks 48, and 96 of this extension study)