Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
Purpose
This is a parallel, Phase 2/Phase 3, 3-arm study to investigate the efficacy, safety, and tolerability of subcutaneous (SC) treatment with lunsekimig compared with placebo in adult participants (aged 40 to 80 years, inclusive) with inadequately controlled Chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype. Participation to the study consists of 3 periods: - Screening period of up to 4 weeks - Randomized intervention period of approximately 48 weeks - Follow-up period: Approximately 8 weeks The study duration will be up to 60 weeks.
Condition
- Chronic Obstructive Pulmonary Disease
Eligibility
- Eligible Ages
- Between 40 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Between 40 to 80 years of age - Physician diagnosed chronic obstructive pulmonary disease (COPD) ≥1 year - Post-bronchodilator forced expiratory volume in 1 second (post-BD FEV1) ≥ 20% and ≤ 70% of predicted value and FEV1/FVC (forced expiratory volume in 1 second /forced vital capacity) <0.70 - Former or current smokers ≥10 pack-years - Chronic Airways Assessment Test (CAAT) ≥10 - ≥2 moderate or ≥1 severe COPD exacerbations in the prior year - Triple (ICS+LABA+LAMA) COPD therapy ≥12 consecutive weeks - EOS (blood eosinophil count) ≥ 150 cells/μL - 18.0 ≤ Body Mass Index ≤ 40.0 kg/m2
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply: - Asthma, including pediatric asthma, or ACOS - Sgnificant pulmonary disease other than COPD - Long-term oxygen therapy >4.0 L/min or requirement of >2.0 L/minO2 saturation to maintain oxygen saturation >88% - Unstable disorder that can impact participants safety or study outcomes - Active or incompletely treated tuberculosis - Current or past malignancies - Concomitant therapies: - long-term macrolides or iPDE-4 unless on stable therapy for >6 months - any biologic therapy or systemic immunosuppressant within 8 weeks or 5 half-lives prior to Screening The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lunsekimig dose regimen A |
Participants will receive lunsekimig dose regimen A. |
|
|
Experimental Lunsekimig dose regimen B |
Participants will receive lunsekimig dose regimen B |
|
|
Placebo Comparator Placebo |
Participants will receive lunsekimig-matching placebo |
|
Recruiting Locations
Phoenix 5308655, Arizona 5551752 85032
Surprise 5316428, Arizona 5551752 85378
La Palma 5364022, California 5332921 90623
Newport Beach 5376890, California 5332921 92663
Boynton Beach 4148677, Florida 4155751 33435
Cutler Bay 6332309, Florida 4155751 33157
Lady Lake 4161118, Florida 4155751 32159
Miami 4164138, Florida 4155751 33126
Miami 4164138, Florida 4155751 33144
Miami Lakes 4164186, Florida 4155751 33014
Orlando 4167147, Florida 4155751 32810
Pembroke Pines 4168139, Florida 4155751 33024
Tampa 4174757, Florida 4155751 33607
Tampa 4174757, Florida 4155751 33607
Cordele 4189423, Georgia 4197000 31015
Indianapolis 4259418, Indiana 4921868 46268
Henderson 5505411, Nevada 5509151 89052
Las Vegas 5506956, Nevada 5509151 89106
Flushing 5117472, New York 5128638 11355
Hickory 4470778, North Carolina 4482348 28601
Chickasha 4533029, Oklahoma 4544379 73018
Beaumont 4672989, Texas 4736286 77701
Boerne 4675373, Texas 4736286 78006
DeSoto 4685524, Texas 4736286 75115
Lampasas 4705176, Texas 4736286 76550
San Antonio 4726206, Texas 4736286 78229
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
All eligible participants will undergo subcutaneous administrations of lunsekimig or matching placebo during a 48-weeks treatment period