Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06676319 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma

Study acronym: AIRLYMPUS
StatusActive, Not Recruiting
PhasePhase 2
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 230 → 221 locations
    • Interventions: Budesonide/Albuterol (Drug), Budesonide/Formoterol (Drug), Fluticasone/Salmeterol (Drug), Lunsekimig (Drug), Placebo (Drug), Short-Acting… to Budesonide/Albuterol (Drug), Budesonide/Formoterol (Drug), Fluticasone/Salmeterol (Drug), Lunsekimig (Drug), Placebo (Drug), Short-Acting…
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 11 entries
  2. Enrollment reduced: 1147 → 556 participantsv22 Show 4 more changesShow less
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion moved earlier from Sep 17, 2027 to Jun 21, 2027
    • Study completion moved earlier from Oct 15, 2027 to Jul 19, 2027
    • Study sites: 229 to 230
  3. Study sites: 230 to 229v21
  4. Trial sites reduced: 236 → 230 locationsv20
  5. Trial sites reduced: 241 → 236 locationsv19
Show 17 earlier versionsHide 17 earlier versions
  1. Study sites: 240 to 241v18
  2. Study sites: 232 to 240v17
  3. Enrollment target: 1000 to 1147v16 Show 5 more changesShow less
    • Primary completion date: Oct 12, 2027 to Sep 17, 2027
    • Study completion date: Nov 12, 2027 to Oct 15, 2027
    • Interventions: Budesonide/formoterol (Drug), Fluticasone/salmeterol (Drug), Lunsekimig (Drug), Placebo (Drug), Short-Acting Beta Agonists (SABA) (Drug) to Budesonide/Albuterol (Drug), Budesonide/Formoterol (Drug), Fluticasone/Salmeterol (Drug), Lunsekimig (Drug), Placebo (Drug), Short-Acting…
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study sites revised (232)
  4. Study sites: 226 to 232v15
  5. Study sites: 223 to 226v14
  6. Study sites: 222 to 223v13
  7. Study sites: 220 to 222v12
  8. Study sites: 206 to 220v11
  9. Study sites: 193 to 206v10
  10. Study sites: 160 to 193v9
  11. Study sites: 132 to 160v8
  12. Study sites: 66 to 132v7
  13. Study sites: 27 to 66v6
  14. Study sites: 16 to 27v5
  15. Study sites: 8 to 16v4
  16. Study sites: 6 to 8v3
  17. Study sites: 2 to 6
    • Start date changed from estimate of Nov 11, 2024 to Nov 7, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
Asthma
956 trials monitored
See 34 trials at risk
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include: * The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.
Trial Details
NCT Number NCT06676319
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Asthma
Related terms Asthma
Enrollment 556 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov