Dose Ranging Study of Amlitelimab in Adult Participants With Moderate-to-severe Asthma
Public ClinicalTrials.gov record NCT05421598. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a parallel, Phase 2, global, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, four-arms study for treatment. The purpose of this study was 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) was 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 was up to approximately 60 weeks. * The scheduled number of visits was 13.
Study identification
- NCT ID
- NCT05421598
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 437 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2022 (Actual)
- Primary completion
- Oct 11, 2024 (Actual)
- Completion
- Mar 20, 2025 (Actual)
- Last update posted
- Mar 30, 2026
2022 – 2025
United States locations
- U.S. sites
- 21
- U.S. states
- 11
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Health Site Number : 8400026 | La Jolla | California | 92093-0990 | — |
| California Allergy and Asthma Medical Group, Inc. Site Number : 8400002 | Los Angeles | California | 90025 | — |
| Allergy Asthma Associates of Santa Clara Valley Site Number : 8400019 | San Jose | California | 95117 | — |
| Bensch Clinical Research LLC Site Number : 8400004 | Stockton | California | 95207 | — |
| Allianz Research Institute Site Number : 8400023 | Westminster | California | 92683 | — |
| Helix Biomedics, LLC Site Number : 8400029 | Boynton Beach | Florida | 33435 | — |
| Renaissance Research and Medical Group, Inc Site Number : 8400030 | Cape Coral | Florida | 33991 | — |
| Beautiful Minds Clinical Research Center Site Number : 8400027 | Cutler Bay | Florida | 33157 | — |
| Reliable Clinical Research, LLC Site Number : 8400020 | Hialeah | Florida | 33012-5853 | — |
| Savin Medical Group, LLC Site Number : 8400015 | Miami | Florida | 33126 | — |
| Pines Care Research Center LLC Site Number : 8400028 | Pembroke Pines | Florida | 33023 | — |
| Treasure Valley Medical Research Site Number : 8400031 | Boise | Idaho | 83706 | — |
| The South Bend Clinic, LLC Site Number : 8400033 | South Bend | Indiana | 46617 | — |
| University of Kansas Medical Center Site Number : 8400016 | Kansas City | Kansas | 66103 | — |
| Johns Hopkins University School of Medicine Site Number : 8400012 | Baltimore | Maryland | 21224 | — |
| Headlands Research Detroit Site Number : 8400032 | Southfield | Michigan | 48034 | — |
| Henderson Clinical Trials Site Number : 8400037 | Henderson | Nevada | 89052 | — |
| Asthma and Allergy Center Site Number : 8400005 | Toledo | Ohio | 43617 | — |
| OK Clinical Research, LLC Site Number : 8400001 | Edmond | Oklahoma | 73034 | — |
| Allergy, Asthma and Clinical Research Center Site Number : 8400035 | Oklahoma City | Oklahoma | 73120 | — |
| TTS Research Site Number : 8400011 | Boerne | Texas | 78006 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 92 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05421598, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 30, 2026 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05421598 live on ClinicalTrials.gov.