Purpose

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig. The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol 2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated: - For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone - For Study ACT18301: LABA with or without LTRA 3. Participants who are able and willing to participate in the open-label extension study, and to comply with requested study visits and procedures 4. Contraception for male and female participants For female participants: - must agree to use contraception/barrier - not pregnant or breast feeding - no eggs donation or cryopreserving eggs For male participants: - No sperm donation or cryopreserving sperm 5. Capable of giving signed informed consent

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply: 1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures 2. Participant who was diagnosed with a new pulmonary disease which may impair lung function 3. Current smoker or active vaping of any products and/or marijuana smoking 4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator 5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study 6. Participants who are receiving prohibited concomitant medications 7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant 8. Concurrent participation in any other clinical study, including non-interventional studies 9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized 10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Lunsekimig
Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval
  • Drug: Lunsekimig
    - Pharmaceutical form: Solution for injection in vial - Route of administration: Subcutaneous injection
    Other names:
    • SAR443765

Recruiting Locations

Allianz Research Institute - Aurora- Site Number : 8400026
Aurora 5412347, Colorado 5417618 80014

Western States Clinical Research- Site Number : 8400014
Wheat Ridge 5443948, Colorado 5417618 80033

Helix Biomedics- Site Number : 8400114
Boynton Beach 4148677, Florida 4155751 33435

Beautiful Minds Clinical Research Center- Site Number : 8400049
Cutler Bay 6332309, Florida 4155751 33157

Qway Research - Hialeah- Site Number : 8400015
Hialeah 4158476, Florida 4155751 33010

High Quality Research- Site Number : 8400039
Miami 4164138, Florida 4155751 33184

Innovations Biotech- Site Number : 8400040
Miami 4164138, Florida 4155751 33186

New Access Medical Center- Site Number : 8400043
Miami 4164138, Florida 4155751 33186

Deluxe Health Center- Site Number : 8400045
Miami Lakes 4164186, Florida 4155751 33014

Windom Allergy, Asthma and Sinus Specialists- Site Number : 8400019
Sarasota 4172131, Florida 4155751 34239

University of Michigan Health System - Ann Arbor- Site Number : 8400004
Ann Arbor 4984247, Michigan 5001836 48109

Midwest Clinical Research Center - St. Louis- Site Number : 8400006
St Louis 4407066, Missouri 4398678 63141

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
Charlotte 4460243, North Carolina 4482348 28287

Asthma & Allergy Center - Toledo- Site Number : 8400017
Toledo 5174035, Ohio 5165418 43617

OK Clinical Research- Site Number : 8400021
Edmond 4535740, Oklahoma 4544379 73034

Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
Pittsburgh 5206379, Pennsylvania 6254927 15241

Orion Clinical Research- Site Number : 8400001
Austin 4671654, Texas 4736286 78759

South Texas Medical Research Institute - TTS Research- Site Number : 8400010
Boerne 4675373, Texas 4736286 78006

Baylor University Medical Center- Site Number : 8400002
Dallas 4684888, Texas 4736286 75246

Western Sky Medical Research- Site Number : 8400023
El Paso 5520993, Texas 4736286 79903

Metroplex Pulmonary and Sleep Center- Site Number : 8400022
McKinney 4710178, Texas 4736286 75069

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Detailed Description

Enter Intervention Groups

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.