Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

Part of paid clinical trials in Stockton, California.

Sponsor
Sanofi
Study ID
NCT06033833
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Amlitelimab — DRUG
    Injection Solution: by subcutaneous injection (SCI)
  • Placebo — DRUG
    Injection Solution: by subcutaneous injection (SCI)

Study Details

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

Key Dates

Start date
Sep 5, 2023
Status verified
May 2026
Primary completion
Sep 29, 2026
Completion
Sep 29, 2026

Study Design

Enrollment
335 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group 1
    Subcutaneous Injection as per protocol
  • Experimental: Treatment group 2
    Subcutaneous injection as per protocol

Primary Outcome Measure

Percentage of participants with treatment-emergent adverse events [ Time Frame: From baseline up to Week 156 (EOS of LTS17510) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Bensch Research Associates- Site Number : 8400004StocktonCalifornia95207-
Helix Biomedics- Site Number : 8400029Boynton BeachFlorida33435-
Savin Medical Group - Miami Lakes- Site Number : 8400015Miami LakesFlorida33014-
Pines Care Research Center- Site Number : 8400028Pembroke PinesFlorida33025-
Treasure Valley Medical Research- Site Number : 8400031BoiseIdaho83706-
Johns Hopkins Bayview Medical Center- Site Number : 8400012BaltimoreMaryland21224-
OK Clinical Research- Site Number : 8400001EdmondOklahoma73034-
South Texas Medical Research Institute - TTS Research- Site Number : 8400011BoerneTexas78006-

Find similar trials in Stockton, CA

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
Bensch Research Associates· Stockton, CAHelix Biomedics· Boynton Beach, FLSavin Medical Group - Miami Lakes· Miami Lakes, FLPines Care Research Center· Pembroke Pines, FLTreasure Valley Medical Research· Boise, IDJohns Hopkins Bayview Medical Center· Baltimore, MD

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