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Monoclonal Antibodies

Lunsekimig for Asthma (AIRPHRODITE Trial)

Phase 2
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2. Participants with stable background therapy of moderate to high ICS therapy (≥500 µg/day to 2000 µg/day fluticasone propionate or equivalent ICS dosage daily) in combination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone as maintained during the parent study in which they have participated
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from parent study baseline to week 96
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the long-term safety and effectiveness of a medication called lunsekimig in adults with moderate-to-severe asthma. Participants who finished the initial study will have the option to join this

Who is the study for?
This trial is for adults with moderate-to-severe asthma who completed the DRI16762 study. They must be on a stable regimen of medium to high-dose inhaled corticosteroids and up to two other controller meds, just like in the previous study. Participants should agree to long-term follow-up, use contraception if applicable, and not be pregnant or donating gametes.
What is being tested?
The trial is testing Lunsekimig's long-term safety and effectiveness for those with moderate-to-severe asthma over a period of up to 96 weeks. It's an open-label extension meaning everyone gets Lunsekimig and knows it; there’s no placebo group.
What are the potential side effects?
While specific side effects are not listed here, typical concerns may include reactions at injection sites, potential respiratory issues due to medication adjustments, or systemic effects that could affect overall health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am on a stable asthma treatment with high-dose inhalers and up to 2 other medicines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from parent study baseline to week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and from parent study baseline to week 96 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized (AQLQ[S]) domain and total scores
Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: LunsekimigExperimental Treatment1 Intervention
Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,215 Previous Clinical Trials
4,046,665 Total Patients Enrolled
51 Trials studying Asthma
29,213 Patients Enrolled for Asthma
~311 spots leftby Jan 2031
Unbiased ResultsWe believe in providing patients with all the options.
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