Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma.

Last updated: May 13, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

Lunsekimig

Clinical Study ID

NCT06609239
LTS17231
LTS17231
  • Ages > 18
  • All Genders

Study Summary

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with moderate-to-severe asthma who have previously completed the parent study. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants who completed the 48-week treatment period of DRI16762 study, includingEOT visit, as per protocol

  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) incombination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone asmaintained during the parent study in which they have participated

  3. Participants who are able and willing to participate in the open-label extensionstudy, 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

  1. Capable of giving signed informed consent

Exclusion

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 anestablished medical condition or requires a new treatment or medication prior toenrollment that, per Investigator's medical judgement would adversely affectparticipation of the participant in this study or would require permanent lunsekimigdiscontinuation, or participants potentially at risk of noncompliance to studyprocedures

  2. Participant who was diagnosed with a new pulmonary disease which may impair lungfunction

  3. Current smoker or active vaping of any products and/or marijuana smoking

  4. Prescription drug or substance abuse, including alcohol, considered significant bythe Investigator

  5. History of hypersensitivity or allergy to lunsekimig or to any of the excipientsused in the presentation or in preparation for administration of lunsekimig, orother allergy that, in the opinion of the Investigator, contraindicatesparticipation in the study

  6. Participants who are receiving prohibited concomitant medications

  7. Participants who, during their participation in the parent study, developed an AE oran SAE deemed related to lunsekimig, which in the opinion of the Investigator couldindicate that continued treatment with lunsekimig may present an unreasonable riskfor the participant

  8. Concurrent participation in any other clinical study, including non-interventionalstudies

  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 directlyinvolved in the conduct of the study, or immediate family members of suchindividuals.

Study Design

Total Participants: 530
Treatment Group(s): 1
Primary Treatment: Lunsekimig
Phase: 2
Study Start date:
September 30, 2024
Estimated Completion Date:
January 20, 2031

Study Description

Enter Intervention Groups

Connect with a study center

  • Investigational Site Number : 0320008

    San Miguel de Tucumán, Tucumán 4000
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320001

    Buenos Aires, 1425
    Argentina

    Active - Recruiting

  • Investigational Site Number : 0320004

    Buenos Aires, 1414
    Argentina

    Active - Recruiting

  • Investigational Site Number : 1520001

    Talca, Maule 3465584
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520002

    Santiago, Reg Metropolitana De Santiago 7750495
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana De Santiago 7500698
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana De Santiago 7500692
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520006

    Santiago, Reg Metropolitana De Santiago 7500587
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520008

    Quillota, Valparaíso 2260877
    Chile

    Active - Recruiting

  • Investigational Site Number : 1520011

    Viña Del Mar, Valparaíso 2520598
    Chile

    Active - Recruiting

  • Investigational Site Number : 1560001

    Guangzhou, 510120
    China

    Active - Recruiting

  • Investigational Site Number : 1560014

    Hohhot, 010050
    China

    Active - Recruiting

  • Investigational Site Number : 1560005

    Wenzhou, 325027
    China

    Active - Recruiting

  • Investigational Site Number : 3760003

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Investigational Site Number : 3760004

    Rehovot, 7610001
    Israel

    Active - Recruiting

  • Investigational Site Number : 3920002

    Sakaide, Kagawa 762-8550
    Japan

    Site Not Available

  • Investigational Site Number : 3920002

    Sakaide-shi, Kagawa 762-8550
    Japan

    Active - Recruiting

  • Investigational Site Number : 3920006

    Kyoto, 610-0113
    Japan

    Active - Recruiting

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi 03722
    Korea, Republic of

    Active - Recruiting

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi 03080
    Korea, Republic of

    Active - Recruiting

  • Investigational Site Number : 4100004

    Seoul, Seoul-teukbyeolsi 05030
    Korea, Republic of

    Active - Recruiting

  • Investigational Site Number : 4100006

    Seoul, Seoul-teukbyeolsi 05505
    Korea, Republic of

    Active - Recruiting

  • Investigational Site Number : 7920001

    Akdeniz, 33070
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920002

    Istanbul, 34098
    Turkey

    Active - Recruiting

  • Investigational Site Number : 7920007

    Kayseri, 38039
    Turkey

    Active - Recruiting

  • Allianz Research Institute CO- Site Number : 8400026

    Aurora, Colorado 80014
    United States

    Active - Recruiting

  • Western States Clinical Research- Site Number : 8400014

    Wheat Ridge, Colorado 80033
    United States

    Active - Recruiting

  • Qway Research - Hialeah- Site Number : 8400015

    Hialeah, Florida 33010
    United States

    Active - Recruiting

  • Clintex Research Group - Miami - Coral Way- Site Number : 8400048

    Miami, Florida 33145
    United States

    Active - Recruiting

  • High Quality Research- Site Number : 8400039

    Miami, Florida 33184
    United States

    Active - Recruiting

  • Innovations Biotech- Site Number : 8400040

    Miami, Florida 33186
    United States

    Active - Recruiting

  • New Access Medical Center- Site Number : 8400043

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029

    Charlotte, North Carolina 28287
    United States

    Active - Recruiting

  • OK Clinical Research, LLC Site Number : 8400021

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • OK Clinical Research- Site Number : 8400021

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • South Texas Medical Research Institute - TTS Research- Site Number : 8400010

    Boerne, Texas 78006
    United States

    Active - Recruiting

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