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Amlitelimab for Asthma (TIDE-asthma Trial)

Phase 2
Waitlist Available
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥ 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)
Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
Awards & highlights

TIDE-asthma Trial Summary

This trial is a Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study assessing the efficacy, safety, and tolerability of add-on therapy with amlitelimab in adult participants with moderate-to-severe asthma. The study duration is up to approximately 76 weeks for participants not going into the long-term safety (LTS) study and up to approximately 64 weeks for participants going into the LTS study. The scheduled number of visits is 13.

Who is the study for?
Adults aged 18-75 with moderate-to-severe asthma, diagnosed for at least a year, who have had a severe exacerbation in the past year despite treatment. They must show certain lung function on tests and be on stable asthma medication doses. Excluded are those with significant drug abuse history, hepatitis B/C or HIV, other chronic lung diseases, recent smokers or heavy past smokers, recent COVID-19 issues, significant infections or transplants, allergies to study drugs, pregnancy/breastfeeding status.Check my eligibility
What is being tested?
The trial is testing Amlitelimab as an add-on therapy for adults with moderate-to-severe asthma against a placebo. Participants will be randomly assigned to one of four groups and followed up for about 60 weeks with approximately 13 visits to assess how well the treatment works and its safety.See study design
What are the potential side effects?
Potential side effects of Amlitelimab may include reactions related to the immune system since it targets specific pathways involved in inflammation. The exact side effects aren't listed but could involve typical drug-related symptoms such as headaches, nausea or more serious immune-related events.

TIDE-asthma Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had a severe asthma attack in the last year while on a medium to high dose of asthma medication.
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I have been diagnosed with moderate to severe asthma for over a year.
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I am between 18 and 75 years old.
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My lung function, measured by FEV1, is between 40% and 80% of the expected value.
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My lung function improves by at least 12% after using a bronchodilator.
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I've been on a strong asthma medication with another controller for 3+ months.
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My weight is between 40 kg and 150 kg.

TIDE-asthma Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized rate of severe exacerbation events over 48 weeks
Secondary outcome measures
Annualized rate of loss of asthma control (LOAC) events 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 ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60
+21 more

TIDE-asthma Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Amlitelimab dose level 3Experimental Treatment1 Intervention
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.
Group II: Amlitelimab dose level 2Experimental Treatment1 Intervention
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.
Group III: Amlitelimab dose level 1Experimental Treatment1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,163 Previous Clinical Trials
3,512,034 Total Patients Enrolled
46 Trials studying Asthma
26,892 Patients Enrolled for Asthma
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,853 Total Patients Enrolled
19 Trials studying Asthma
9,187 Patients Enrolled for Asthma

Media Library

Amlitelimab Clinical Trial Eligibility Overview. Trial Name: NCT05421598 — Phase 2
Asthma Research Study Groups: Amlitelimab dose level 3, Placebo, Amlitelimab dose level 1, Amlitelimab dose level 2
Asthma Clinical Trial 2023: Amlitelimab Highlights & Side Effects. Trial Name: NCT05421598 — Phase 2
Amlitelimab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421598 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could participants aged 80 and above participate in this investigation?

"This medical experiment is seeking volunteers who are of age 18 or above and below the age of 75."

Answered by AI

Is the recruitment period for this study still ongoing?

"Per the information on clinicaltrials.gov, this research is still open for recruitment of participants. The trial was initially posted to the website on June 30th 2022 and has undergone its most recent amendment on October 24th 2022."

Answered by AI

How prevalent is the implementation of this research project in Canada?

"This experiment has 7 recruiting sites, including Allergy & Asthma Center of Boerne-Site Number:8400011 in Boerne, OK Clinical Research-Site Number:8400001 in Edmond and Investigational Site Number :1240007 in Trois-Rivieres. Other participating locations are also included."

Answered by AI

What is the current recruitment quota for this clinical trial?

"Sanofi, the sponsor of this trial, aims to recruit 420 individuals that satisfy all study criteria. Patients can be accepted at Allergy & Asthma Center of Boerne-Site Number:8400011 in Boerne, Texas and OK Clinical Research-Site Number:8400001 in Edmond, Oklahoma."

Answered by AI

What qualifications are required for potential participants of this clinical experiment?

"This clinical trial is accepting 420 participants between the ages of 18 and 75 with a pre-existing asthma diagnosis. The aspirants must fulfill the following requirements: Be in an age bracket between 18 to 75, possess a 5-item ACQ score over 1.5 at randomization, have their weight be greater than 40 kg and less than 150 kg during enrollment, show moderate or severe signs of Asthma diagnosed by a physician for 12 months according to Global Initiative For Asthma (GINA) guidelines, suffered from one serious exacerbation within last year while under medium/high dose ICS therapy (>500 μg fluticasone propion"

Answered by AI

Has the FDA sanctioned Amlitelimab for medical use?

"Taking into account that this is a Phase 2 trial and there is data to support its safety, Amlitelimab has been given an assessment of two. Unfortunately, no prior studies have proved efficacy for the drug."

Answered by AI

Who else is applying?

What state do they live in?
Kansas
What site did they apply to?
University of Kansas Medical Center-Site Number:8400016
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
2022. "Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05421598.
All > Pediatric Asthma > Asthma
~83 spots leftby Oct 2024
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