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

Phase 2

Recruiting

• Conditions: Asthma
• Interventions: Drug: Lunsekimig

• Registration Number: NCT06609239
• Lead Sponsor: Sanofi

Brief 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.

Detailed Description

Enter Intervention Groups

Study Timeline

• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Study Start: 2024-09-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-14
• Primary Completion: 2031-01-20
• Study Completion: 2031-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

1. Participants who completed the 48-week treatment period of DRI16762 study, including EOT 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) in combination with at least 1 but no more than 2 additional controller medications (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone as maintained during the parent study in which they have participated

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lunsekimig	Lunsekimig	Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval

Primary Outcome Measures

Name	Time	Method
Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)	From study baseline to week 100

Secondary Outcome Measures

Name	Time	Method
Annualized rate of asthma exacerbation events	From study baseline to week 96
Change from parent study baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)	From parent study baseline to week 48
Change from parent study baseline in pre bronchodilator (BD) FEV1	From parent study baseline to week 96
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activities for 12 years and older (AQLQ[S] +12) domain and total scores	From parent study baseline to week 96
Serum lunsekimig concentrations	From study baseline to week 100
Incidence and titer of anti-drug antibodies (ADA) against lunsekimig	From study baseline to week 100
Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score	From parent study baseline to week 48	The ACQ-5 is a questionnaire that measures the adequacy of asthma control and any changes in asthma control that may occur spontaneously or as a result of treatment. The ACQ-5 has five questions on the asthma symptoms and patients are asked to recall how their asthma has been during the previous week and to respond on a 7-point scale for each question (0 = no impairment, 6 = maximum impairment). The ACQ-5 score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score	From parent study baseline to week 96
Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score	From parent study baseline to week 96	Defined as ACQ-5 responder analysis
Change from parent study baseline in Asthma Quality of Life Questionnaire Standardized Activites for 12 years and older (AQLQ[S] +12) domain and total scores	From parent study baseline to week 48	The AQLQ(S) + 12 was designed as a self-administered patient reported outcome to measure the functional impairments that are most troublesome to adolescents and adults ≥12 years of age as a result of their asthma. The instrument is comprised of 32 items, each rated on a 7-point Likert scales from 1 to 7. Higher scores indicate better quality of life.

Trial Locations

Locations (35)

Allianz Research Institute CO- Site Number : 8400026; 🇺🇸 Aurora, Colorado, United States

Western States Clinical Research- Site Number : 8400014; 🇺🇸 Wheat Ridge, Colorado, United States

Qway Research - Hialeah- Site Number : 8400015; 🇺🇸 Hialeah, Florida, United States

Clintex Research Group - Miami - Coral Way- Site Number : 8400048; 🇺🇸 Miami, Florida, United States

High Quality Research- Site Number : 8400039; 🇺🇸 Miami, Florida, United States

Innovations Biotech- Site Number : 8400040; 🇺🇸 Miami, Florida, United States

New Access Medical Center- Site Number : 8400043; 🇺🇸 Miami, Florida, United States

Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029; 🇺🇸 Charlotte, North Carolina, United States

OK Clinical Research- Site Number : 8400021; 🇺🇸 Edmond, Oklahoma, United States

Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007; 🇺🇸 Pittsburgh, Pennsylvania, United States

South Texas Medical Research Institute - TTS Research- Site Number : 8400010; 🇺🇸 Boerne, Texas, United States

Investigational Site Number : 0320008; 🇦🇷 San Miguel de Tucumán, Tucumán, Argentina

Investigational Site Number : 0320004; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 0320001; 🇦🇷 Buenos Aires, Argentina

Investigational Site Number : 1520001; 🇨🇱 Talca, Maule, Chile

Investigational Site Number : 1520006; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520005; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520004; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520002; 🇨🇱 Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1520008; 🇨🇱 Quillota, Valparaíso, Chile

Investigational Site Number : 1520011; 🇨🇱 Viña Del Mar, Valparaíso, Chile

Investigational Site Number : 1560001; 🇨🇳 Guangzhou, China

Investigational Site Number : 1560014; 🇨🇳 Hohhot, China

Investigational Site Number : 1560005; 🇨🇳 Wenzhou, China

Investigational Site Number : 3760003; 🇮🇱 Jerusalem, Israel

Investigational Site Number : 3760004; 🇮🇱 Rehovot, Israel

Investigational Site Number : 3920002; 🇯🇵 Sakaide-shi, Kagawa, Japan

Investigational Site Number : 3920006; 🇯🇵 Kyoto, Japan

Investigational Site Number : 4100002; 🇰🇷 Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4100001; 🇰🇷 Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4100004; 🇰🇷 Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 4100006; 🇰🇷 Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 7920001; 🇹🇷 Akdeniz, Turkey

Investigational Site Number : 7920002; 🇹🇷 Istanbul, Turkey

Investigational Site Number : 7920007; 🇹🇷 Kayseri, Turkey