Clinical trial NCT06609239: Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Moderatetosevere Asthma.
Official title: An Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of Subcutaneous Lunsekimig in Adult Participants With Moderatetosevere Asthma Who Participated in Study DRI16762
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants having any treatmentemergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)
timeFrame: From study baseline to week 100
Secondary outcomes:
measure: Annualized rate of asthma exacerbation events
timeFrame: From study baseline to week 48
measure: Annualized rate of asthma exacerbation events
timeFrame: From study baseline to week 96
measure: Change from parent study baseline in prebronchodilator (BD) forced expiratory volume in 1 second (FEV1)
timeFrame: From parent study baseline to week 48
measure: Change from parent study baseline in pre bronchodilator (BD) FEV1
timeFrame: From parent study baseline to week 96
measure: Change from parent study baseline in Asthma Control Questionnaire5 (ACQ-5) score
timeFrame: From parent study baseline to week 48
measure: Change from parent study baseline in Asthma Control Questionnaire 5 (ACQ-5) score
timeFrame: From parent study baseline to week 96
measure: Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score
timeFrame: From parent study baseline to week 48
measure: Proportion of participants with ≥0.5-point reduction in each score as compared to parent study baseline score
timeFrame: From parent study baseline to week 96
measure: 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
timeFrame: From parent study baseline to week 48
measure: 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
timeFrame: From parent study baseline to week 96
measure: Serum lunsekimig concentrations
timeFrame: From study baseline to week 100
measure: Incidence and titer of anti-drug antibodies (ADA) against lunsekimig
timeFrame: From study baseline to week 100
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Allianz Research Institute CO- Site Number : 8400026
state: Colorado
city: Wheat Ridge
country: United States
facility: Western States Clinical Research- Site Number : 8400014
state: Colorado
city: Hialeah
country: United States
facility: Qway Research - Hialeah- Site Number : 8400015
state: Florida
city: Miami
country: United States
facility: Clintex Research Group - Miami - Coral Way- Site Number : 8400048
state: Florida
city: Miami
country: United States
facility: High Quality Research- Site Number : 8400039
state: Florida
city: Miami
country: United States
facility: Innovations Biotech- Site Number : 8400040
state: Florida
city: Miami
country: United States
facility: New Access Medical Center- Site Number : 8400043
state: Florida
city: Charlotte
country: United States
facility: Tryon Medical Partners - Charlotte - Piedmont Row Drive South- Site Number : 8400029
state: North Carolina
city: Edmond
country: United States
facility: OK Clinical Research- Site Number : 8400021
state: Oklahoma
city: Pittsburgh
country: United States
facility: Allergy & Clinical Immunology Associates Pittsburgh- Site Number : 8400007
state: Pennsylvania
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8400010
state: Texas
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320008
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Talca
country: Chile
facility: Investigational Site Number : 1520001
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520006
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520004
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520008
state: Valparaíso
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520011
state: Valparaíso
city: Guangzhou
country: China
facility: Investigational Site Number : 1560001
city: Hohhot
country: China
facility: Investigational Site Number : 1560014
city: Wenzhou
country: China
facility: Investigational Site Number : 1560005
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760004
city: Sakaide-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Kagawa
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920006
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100004
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920007
Study officials:
References: