Back to resultsDose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma (TIDE-asthma)
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Amlitelimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
- Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
- Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines) for at least 3 months.
- ≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
- Participants with pre-BD forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal at the screening visit.
- 5-item ACQ-5 score >1.5 at randomization.
- Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
- Weight ≥40 kg and ≤150 kg at the randomization visit.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Chronic lung disease other than asthma.
- Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of >10 pack-years.
- Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
- Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
- Active infection or history of clinically significant infection
- Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- Active or latent tuberculosis (TB)
- A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured >3 years prior to baseline).
- History of solid organ transplant.
- Hepatitis B, C or HIV.
- Pregnant or breastfeeding.
- History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
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:8400002Recruiting
- Allergy Asthma Associates of Santa Clara Valley-Site Number:8400019Recruiting
- Bensch Clinical Research LLC-Site Number:8400004Recruiting
- Allianz Research Institute-Site Number:8400023Recruiting
- Helix Biomedics, LLC-Site Number:8400029Recruiting
- Renaissance Research and Medical Group, Inc-Site Number:8400030Recruiting
- Beautiful Minds Clinical Research Center-Site Number:8400027Recruiting
- Reliable Clinical Research, LLC-Site Number:8400020Recruiting
- Savin Medical Group, LLC-Site Number:8400015Recruiting
- Pines Care Research Center LLC-Site Number:8400028Recruiting
- Treasure Valley Medical Research-Site Number:8400031Recruiting
- University of Kansas Medical Center-Site Number:8400016Recruiting
- Johns Hopkins University School of Medicine-Site Number:8400012Recruiting
- Headlands Research Detroit-Site Number:8400032Recruiting
- Henderson Clinical Trials-Site Number:8400037Recruiting
- Asthma and Allergy Center-Site Number:8400005Recruiting
- OK Clinical Research-Site Number:8400001Recruiting
- Allergy, Asthma and Clinical Research Center-Site Number:8400035Recruiting
- TTS Research-Site Number:8400011Recruiting
- Allergy Associates of Utah-Site Number:8400003Recruiting
- Investigational Site Number :0320001Recruiting
- Investigational Site Number :0320002Recruiting
- Investigational Site Number :0320008Recruiting
- Investigational Site Number :0320009Recruiting
- Investigational Site Number :0320006Recruiting
- Investigational Site Number :0320007Recruiting
- Investigational Site Number :0320005Recruiting
- Investigational Site Number :0320004Recruiting
- Investigational Site Number :0320003Recruiting
- Investigational Site Number :0760004Recruiting
- Investigational Site Number :0760002Recruiting
- Investigational Site Number :0760010Recruiting
- Investigational Site Number :0760001Recruiting
- Investigational Site Number :0760007Recruiting
- Investigational Site Number :0760006Recruiting
- Investigational Site Number :0760008Recruiting
- Investigational Site Number :0760003Recruiting
- Investigational Site Number :1240009Recruiting
- Investigational Site Number :1240006Recruiting
- Investigational Site Number :1240008Recruiting
- Investigational Site Number :1240005Recruiting
- Investigational Site Number :1240004Recruiting
- Investigational Site Number :1240007Recruiting
- Investigational Site Number :1240003Recruiting
- Investigational Site Number :1520006Recruiting
- Investigational Site Number :1520007Recruiting
- Investigational Site Number :1520001Recruiting
- Investigational Site Number :1520002Recruiting
- Investigational Site Number :1520009Recruiting
- Investigational Site Number :1520008Recruiting
- Investigational Site Number :1520003Recruiting
- Investigational Site Number :1520005Recruiting
- Investigational Site Number :3480007Recruiting
- Investigational Site Number :3480009Recruiting
- Investigational Site Number :3480011Recruiting
- Investigational Site Number :3480002Recruiting
- Investigational Site Number :3480004Recruiting
- Investigational Site Number :3480006Recruiting
- Investigational Site Number :3480012Recruiting
- Investigational Site Number :3480003Recruiting
- Investigational Site Number :3800002Recruiting
- Investigational Site Number :3800003Recruiting
- Investigational Site Number :3800004Recruiting
- Investigational Site Number :3800001Recruiting
- Investigational Site Number :3920007Recruiting
- Investigational Site Number :3920014Recruiting
- Investigational Site Number :3920012Recruiting
- Investigational Site Number :3920002Recruiting
- Investigational Site Number :3920016Recruiting
- Investigational Site Number :3920006Recruiting
- Investigational Site Number :3920013Recruiting
- Investigational Site Number :3920015Recruiting
- Investigational Site Number :3920010Recruiting
- Investigational Site Number :3920017Recruiting
- Investigational Site Number :3920005Recruiting
- Investigational Site Number :3920004Recruiting
- Investigational Site Number :3920003Recruiting
- Investigational Site Number :3920020Recruiting
- Investigational Site Number :3920001Recruiting
- Investigational Site Number :3920011Recruiting
- Investigational Site Number :3920009Recruiting
- Investigational Site Number :3920018Recruiting
- Investigational Site Number :3920008Recruiting
- Investigational Site Number :3920019Recruiting
- Investigational Site Number :4100004Recruiting
- Investigational Site Number :4100003Recruiting
- Investigational Site Number :4100001Recruiting
- Investigational Site Number :4100005Recruiting
- Investigational Site Number :4100002Recruiting
- Investigational Site Number :4100006Recruiting
- Investigational Site Number :4100007Recruiting
- Investigational Site Number :4840001Recruiting
- Investigational Site Number :4840005Recruiting
- Investigational Site Number :4840002Recruiting
- Investigational Site Number :4840004Recruiting
- Investigational Site Number :4840006Recruiting
- Investigational Site Number :4840008Recruiting
- Investigational Site Number :6160006Recruiting
- Investigational Site Number :6160004Recruiting
- Investigational Site Number :6160001Recruiting
- Investigational Site Number :6160003Recruiting
- Investigational Site Number :6160002Recruiting
- Investigational Site Number :6160007Recruiting
- Investigational Site Number :7100007Recruiting
- Investigational Site Number :7100002Recruiting
- Investigational Site Number :7100005Recruiting
- Investigational Site Number :7100001Recruiting
- Investigational Site Number :7100003Recruiting
- Investigational Site Number :7100006Recruiting
- Investigational Site Number :7100008Recruiting
- Investigational Site Number :7100004Recruiting
- Investigational Site Number: 7920001Recruiting
- Investigational site number 7920003Recruiting
- Investigational site number 7920008Recruiting
- Investigational site number 7920005Recruiting
- Investigational site number 7920002Recruiting
- Investigational Site Number :8260003Recruiting
- Investigational Site Number :8260001Recruiting
- Investigational Site Number :8260002Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Amlitelimab dose level 1
Amlitelimab dose level 2
Amlitelimab dose level 3
Placebo
Arm Description
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 1 every 4 weeks (Q4W) until Week 20 (inclusive) and every 12 weeks (Q12W) starting from Week 24 and thereafter.
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 2 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 3 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Initial loading dose of amlitelimab matching placebo on Day 1, followed by one injection of amlitelimab matching placebo Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Outcomes
Primary Outcome Measures
Annualized rate of severe exacerbation events over 48 weeks
Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Secondary Outcome Measures
Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48
Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48.
Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) score at Week 48
The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Week 48
The AQLQ(S) is designed as a self-administered participant reported outcome to measure the functional impairments. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.
Change from baseline in post-BD FEV1 at Week 48
Change from baseline in post-BD FEV1 at Week 48.
The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD)
The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD).
Change from baseline in ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60
The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Time to first severe exacerbation event
Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Change from baseline in pre-BD and post-BD FEV1
Change from baseline in pre-BD and post-BD FEV1.
Change from baseline in peak expiratory flow (PEF) and forced expiratory flow (FEF) 25-75%
Change from baseline in peak expiratory flow (PEF) and forced expiratory flow (FEF) 25-75%.
Change from baseline in forced vital capacity (FVC)
Change from baseline in forced vital capacity (FVC).
Change from baseline in FeNO at Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
Change from baseline in FeNO at Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60.
Annualized rate of loss of asthma control (LOAC) events during 48 weeks of treatment
LOAC events are defined by one or several of the following criteria:
A 30% or greater reduction from baseline in morning PEF on 2 consecutive days.
≥6 additional reliever puffs of short-acting beta-agonists (SABA) OR ≥4 additional puffs of low-dose inhaled corticosteroid (ICS)/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days Increase in ICS ≥4 times than the Visit 2 dose Severe exacerbation event
Time to first LOAC event
LOAC events are defined by one or several of the following criteria:
A 30% or greater reduction from baseline in morning PEF on 2 consecutive days.
≥6 additional reliever puffs of short-acting beta-agonists (SABA) OR ≥4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days Increase in ICS ≥4 times than the Visit 2 dose Severe exacerbation event
Change from baseline in the Asthma Daytime Symptom Diary (ADSD) 7-item daily morning score and in the Asthma Nighttime Symptom Diary (ANSD) 7-item daily evening scores at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
ADSD and ANSD have been designed to measure asthma symptoms. Both have overall score from 0- 10 with higher score indicating worse symptom.
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment.
Change from baseline in the numbers of inhalations/day of SABA or low-dose ICS/formoterol for symptom relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Change from baseline in the numbers of inhalations/day of SABA or low-dose ICS/formoterol for symptom relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60.
Serum amlitelimab concentrations measured throughout the study
Serum amlitelimab concentrations measured throughout the study.
Incidence of anti-amlitelimab antibody positive response
Incidence of anti-amlitelimab antibody positive response.
Percentage of participants with treatment-emergent adverse events (TEAEs), including local reactions, AEs of special interest (AESIs), serious adverse events (SAEs)
Percentage of participants with treatment-emergent adverse events (TEAEs), including local reactions, AEs of special interest (AESIs), serious adverse events (SAEs).
Incidence of potentially clinically significant laboratory test, vital signs, and ECG abnormalities in the treatment period
Incidence of potentially clinically significant laboratory test, vital signs, and ECG abnormalities in the treatment period.
Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Weeks 2, 4, 8, 12, 24, 36, and 60
The AQLQ(S) is designed as a self-administered participant reported outcome to measure the functional impairments. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
The SGRQ is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health.
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 48
The SGRQ is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health.
Change from baseline in ACQ-6 score and ACQ-7 at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. The overall scale ranges from 0 = 'totally controlled' to 6 = 'severely unc7ntrolled. The ACQ-7 is a validated asthma assessment tool that consists of 6 self-assessment questions. The overall scale ranges from 0 = 'totally controlled' to 6 = 'severely uncontrolled.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05421598
Brief Title
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Acronym
TIDE-asthma
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
September 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
October 4, 2024 (Anticipated)
Study Completion Date
March 21, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment.
The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma.
Study details include:
The study duration (per participant) will be up to approximately 76 weeks for participants not going into LTS study and will be up to approximately 64 weeks for participants going into LTS study.
The randomized treatment duration will be up to approximately 60 weeks.
The scheduled number of visits will be 13.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amlitelimab dose level 1
Arm Type
Experimental
Arm Description
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 1 every 4 weeks (Q4W) until Week 20 (inclusive) and every 12 weeks (Q12W) starting from Week 24 and thereafter.
Arm Title
Amlitelimab dose level 2
Arm Type
Experimental
Arm Description
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 2 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Arm Title
Amlitelimab dose level 3
Arm Type
Experimental
Arm Description
Initial loading dose of amlitelimab on Day 1, followed by one injection of amlitelimab dose level 3 Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Initial loading dose of amlitelimab matching placebo on Day 1, followed by one injection of amlitelimab matching placebo Q4W until Week 20 (inclusive) and Q12W starting from Week 24 and thereafter.
Intervention Type
Drug
Intervention Name(s)
Amlitelimab
Intervention Description
Injection solution Subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection solution Subcutaneous injection
Primary Outcome Measure Information:
Title
Annualized rate of severe exacerbation events over 48 weeks
Description
Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Time Frame
Baseline through Week 48
Secondary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48
Description
Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48.
Time Frame
Baseline to Week 48
Title
Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) score at Week 48
Description
The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Time Frame
Baseline to Week 48
Title
Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Week 48
Description
The AQLQ(S) is designed as a self-administered participant reported outcome to measure the functional impairments. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.
Time Frame
Baseline to Week 48
Title
Change from baseline in post-BD FEV1 at Week 48
Description
Change from baseline in post-BD FEV1 at Week 48.
Time Frame
Baseline to Week 48
Title
The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD)
Description
The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD).
Time Frame
Baseline to Week 48
Title
Change from baseline in ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60
Description
The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, and 60
Title
Time to first severe exacerbation event
Description
Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for ≥3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids.
Time Frame
Baseline through Week 48
Title
Change from baseline in pre-BD and post-BD FEV1
Description
Change from baseline in pre-BD and post-BD FEV1.
Time Frame
Baseline to Weeks 2, 4, 8, 12,16, 24, 36 and 60
Title
Change from baseline in peak expiratory flow (PEF) and forced expiratory flow (FEF) 25-75%
Description
Change from baseline in peak expiratory flow (PEF) and forced expiratory flow (FEF) 25-75%.
Time Frame
Baseline to Weeks 4, 12, 24, 36, 48 and 60
Title
Change from baseline in forced vital capacity (FVC)
Description
Change from baseline in forced vital capacity (FVC).
Time Frame
Baseline to Weeks 4, 12, 24, 36, 48 and 60
Title
Change from baseline in FeNO at Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
Description
Change from baseline in FeNO at Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
Title
Annualized rate of loss of asthma control (LOAC) events during 48 weeks of treatment
Description
LOAC events are defined by one or several of the following criteria:
A 30% or greater reduction from baseline in morning PEF on 2 consecutive days.
≥6 additional reliever puffs of short-acting beta-agonists (SABA) OR ≥4 additional puffs of low-dose inhaled corticosteroid (ICS)/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days Increase in ICS ≥4 times than the Visit 2 dose Severe exacerbation event
Time Frame
Baseline through Week 48
Title
Time to first LOAC event
Description
LOAC events are defined by one or several of the following criteria:
A 30% or greater reduction from baseline in morning PEF on 2 consecutive days.
≥6 additional reliever puffs of short-acting beta-agonists (SABA) OR ≥4 additional puffs of low-dose ICS/formoterol in a 24-hour period (compared to baseline) on 2 consecutive days Increase in ICS ≥4 times than the Visit 2 dose Severe exacerbation event
Time Frame
Baseline through Week 48
Title
Change from baseline in the Asthma Daytime Symptom Diary (ADSD) 7-item daily morning score and in the Asthma Nighttime Symptom Diary (ANSD) 7-item daily evening scores at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Description
ADSD and ANSD have been designed to measure asthma symptoms. Both have overall score from 0- 10 with higher score indicating worse symptom.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Title
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment
Description
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment.
Time Frame
Baseline through Week 48
Title
Change from baseline in the numbers of inhalations/day of SABA or low-dose ICS/formoterol for symptom relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Description
Change from baseline in the numbers of inhalations/day of SABA or low-dose ICS/formoterol for symptom relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Title
Serum amlitelimab concentrations measured throughout the study
Description
Serum amlitelimab concentrations measured throughout the study.
Time Frame
Baseline thought Week 60
Title
Incidence of anti-amlitelimab antibody positive response
Description
Incidence of anti-amlitelimab antibody positive response.
Time Frame
Baseline through Week 60
Title
Percentage of participants with treatment-emergent adverse events (TEAEs), including local reactions, AEs of special interest (AESIs), serious adverse events (SAEs)
Description
Percentage of participants with treatment-emergent adverse events (TEAEs), including local reactions, AEs of special interest (AESIs), serious adverse events (SAEs).
Time Frame
Baseline through Week 60
Title
Incidence of potentially clinically significant laboratory test, vital signs, and ECG abnormalities in the treatment period
Description
Incidence of potentially clinically significant laboratory test, vital signs, and ECG abnormalities in the treatment period.
Time Frame
Baseline through Week 60
Title
Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Weeks 2, 4, 8, 12, 24, 36, and 60
Description
The AQLQ(S) is designed as a self-administered participant reported outcome to measure the functional impairments. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, and 60
Title
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Description
The SGRQ is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Title
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 48
Description
The SGRQ is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health.
Time Frame
Week 48
Title
Change from baseline in ACQ-6 score and ACQ-7 at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
Description
The ACQ-6 is a validated asthma assessment tool that consists of 6 self-assessment questions. The overall scale ranges from 0 = 'totally controlled' to 6 = 'severely unc7ntrolled. The ACQ-7 is a validated asthma assessment tool that consists of 6 self-assessment questions. The overall scale ranges from 0 = 'totally controlled' to 6 = 'severely uncontrolled.
Time Frame
Baseline to Weeks 2, 4, 8, 12, 24, 36, 48, and 60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic antagonist [LAMA], methylxanthines) for at least 3 months.
≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
Participants with pre-BD forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal at the screening visit.
5-item ACQ-5 score >1.5 at randomization.
Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
Weight ≥40 kg and ≤150 kg at the randomization visit.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Chronic lung disease other than asthma.
Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of >10 pack-years.
Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
Active infection or history of clinically significant infection
Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
Active or latent tuberculosis (TB)
A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured >3 years prior to baseline).
History of solid organ transplant.
Hepatitis B, C or HIV.
Pregnant or breastfeeding.
History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.
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:8400002
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy Asthma Associates of Santa Clara Valley-Site Number:8400019
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Name
Bensch Clinical Research LLC-Site Number:8400004
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Individual Site Status
Recruiting
Facility Name
Allianz Research Institute-Site Number:8400023
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Individual Site Status
Recruiting
Facility Name
Helix Biomedics, LLC-Site Number:8400029
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Individual Site Status
Recruiting
Facility Name
Renaissance Research and Medical Group, Inc-Site Number:8400030
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33991
Country
United States
Individual Site Status
Recruiting
Facility Name
Beautiful Minds Clinical Research Center-Site Number:8400027
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Reliable Clinical Research, LLC-Site Number:8400020
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012-5853
Country
United States
Individual Site Status
Recruiting
Facility Name
Savin Medical Group, LLC-Site Number:8400015
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Pines Care Research Center LLC-Site Number:8400028
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Individual Site Status
Recruiting
Facility Name
Treasure Valley Medical Research-Site Number:8400031
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Medical Center-Site Number:8400016
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University School of Medicine-Site Number:8400012
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Headlands Research Detroit-Site Number:8400032
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
Individual Site Status
Recruiting
Facility Name
Henderson Clinical Trials-Site Number:8400037
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Asthma and Allergy Center-Site Number:8400005
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
OK Clinical Research-Site Number:8400001
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy, Asthma and Clinical Research Center-Site Number:8400035
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
TTS Research-Site Number:8400011
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Individual Site Status
Recruiting
Facility Name
Allergy Associates of Utah-Site Number:8400003
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320008
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
B1900BNN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320009
City
Buenos Aires
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
1060
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320006
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320007
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DEJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320005
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760004
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40060-330
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760002
City
Vitoria
State/Province
Espírito Santo
ZIP/Postal Code
29055 450
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760010
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760001
City
Passo Fundo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
99010-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760007
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760006
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760008
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760003
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240009
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240006
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240008
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240005
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240007
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520006
City
Talca
State/Province
Maule
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520007
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500692
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500698
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520009
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7640881
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520008
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8380465
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8910131
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Quillota
State/Province
Valparaíso
ZIP/Postal Code
2260877
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480007
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480009
City
Edelény
ZIP/Postal Code
3780
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480011
City
Gödöllö
ZIP/Postal Code
2100
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480002
City
Hajdunánás
ZIP/Postal Code
4080
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480004
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480006
City
Puspokladany
ZIP/Postal Code
4150
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480012
City
Szazhalombatta
ZIP/Postal Code
2440
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800002
City
Cona (FE)
State/Province
Emilia-Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800004
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920014
City
Narita-shi
State/Province
Chiba
ZIP/Postal Code
286-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920012
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Kamakura-shi
State/Province
Kanagawa
ZIP/Postal Code
247-0072
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920016
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920013
City
Nankoku-shi
State/Province
Kochi
ZIP/Postal Code
783-8509
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920015
City
Kumamoto-shi
State/Province
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920017
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920005
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920020
City
Kiyose-shi
State/Province
Tokyo
ZIP/Postal Code
204-8585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920011
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Tachikawa-shi
State/Province
Tokyo
ZIP/Postal Code
190-0014
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920018
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Fukuoka-shi
ZIP/Postal Code
811-1394
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920019
City
Hiroshima-shi
ZIP/Postal Code
730-0013
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100004
City
Daegu
State/Province
Daegu-gwangyeoksi
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100003
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100001
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100005
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100002
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
138-878
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100006
City
Seoul
State/Province
Teukbyeolsi
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100007
City
Seongnam-si, Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840001
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840005
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840002
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Durango, Durango
ZIP/Postal Code
34080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840006
City
Tlalnepantla
ZIP/Postal Code
54055
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840008
City
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160006
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160004
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160003
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160002
City
Gdansk
ZIP/Postal Code
80344
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160007
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100007
City
Benoni
ZIP/Postal Code
1501
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100002
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100005
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100001
City
Cape Town
ZIP/Postal Code
7937
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100003
City
Durban
ZIP/Postal Code
4071
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100006
City
George
ZIP/Postal Code
6530
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100008
City
Johannesburg
ZIP/Postal Code
1401
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100004
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number: 7920001
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational site number 7920003
City
İzmir
ZIP/Postal Code
35100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational site number 7920008
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational site number 7920005
City
Kocaeli
ZIP/Postal Code
41100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational site number 7920002
City
Mersin
ZIP/Postal Code
33110
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260003
City
London
State/Province
London, City Of
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260001
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260002
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Recruiting
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
Learn more about this trial
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
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