Amlitelimab for Asthma

(TIDE-asthma Trial)

Recruiting at 252 trial locations

Overseen By Trial Transparency email recommended (Toll free number for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: ICS, LABA

Must not be taking: Anti-OX40, Anti-OX40L

Disqualifiers: Chronic lung disease, Smoking, COVID-19, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 13

Duration: 60 weeks

446 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing amlitelimab, a medication added to current treatments, in adults with moderate-to-severe asthma. It aims to reduce airway inflammation and improve breathing.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should already be on medium to high doses of inhaled corticosteroids (ICS) and at least one additional controller medication for asthma. It's best to discuss your specific medications with the trial team.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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.

Inclusion Criteria

I've had a severe asthma attack in the last year while on a medium to high dose of asthma medication.

I have been diagnosed with moderate to severe asthma for over a year.

I am between 18 and 75 years old.

Exclusion Criteria

I have a history of serious immune system problems or frequent, long-lasting infections.

I have had COVID-19 or symptoms of it recently, or I needed advanced breathing support due to COVID-19 in the last 3 months.

You have hepatitis B, hepatitis C, or HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous amlitelimab or placebo in a randomized, double-blind manner for up to 60 weeks

60 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Long-term follow-up (optional)

Participants may opt into a long-term follow-up study

12 weeks

Treatment Details

Interventions

• Amlitelimab

Trial Overview 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.

Participant Groups

Group I: Amlitelimab dose level 3 Experimental Treatment 1 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 2 Experimental Treatment 1 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 1 Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University