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 (TIDE-asthma)

  • STATUS
    Recruiting
  • End date
    Mar 21, 2025
  • participants needed
    420
  • sponsor
    Sanofi
Updated on 13 October 2022
Investigator
Trial Transparency email recommended (Toll free number for US & Canada)
Primary Contact
Investigational Site Number :1240005 (10.1 mi away) Contact
+5 other location

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.

Details
Condition Asthma
Treatment Placebo, Amlitelimab
Clinical Study IdentifierNCT05421598
SponsorSanofi
Last Modified on13 October 2022

Eligibility

Yes No Not Sure

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
-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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Primary Contact

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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