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Compares treatment options for Chronic Obstructive Pulmonary Disease
Official title 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
ClinicalTrials.gov ID: NCT07190209
What this study is testing
What is Lunsekimig?
Lunsekimig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic obstructive pulmonary disease.
Also referred to as SAR443765.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a parallel, Phase 2b/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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- Former or current smokers ≥10 pack-years
- Chronic Airways Assessment Test (CAAT) ≥10
You likely can't join if
- Participants are excluded from the study if any of the following criteria apply:
- Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
- Significant pulmonary disease other than COPD
- Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
- Unstable disorder that can impact participants safety or study outcomes
- Active or incompletely treated tuberculosis
See the full eligibility 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
- Participants are excluded from the study if any of the following criteria apply:
- Asthma, including pediatric asthma, or asthma-COPD overlap syndrome (ACOS)
- Significant pulmonary disease other than COPD
- Long-term oxygen therapy \>4.0 L/min or requirement of \>2.0 L/min to maintain oxygen saturation \>88% at rest
- 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 phosphodiesterase Type 3 (PDE-3) or PDE-4 inhibitors unless on stable therapy for \>6 months
- any biologic therapy or systemic immunosuppressant within 4 months or 5 half-lives prior to Screening The above information is not intended to contain all considerations relevant to a patient's potential participation...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Phoenix, Arizona, United States
- Surprise, Arizona, United States
- La Palma, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Newport Beach, California, United States
- Redding, California, United States
- Valencia, California, United States
- Boynton Beach, Florida, United States
- Cutler Bay, Florida, United States
- Fort Myers, Florida, United States
- Lady Lake, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Pembroke Pines, Florida, United States
- Tampa, Florida, United States
- Cordele, Georgia, United States
- Fayetteville, Georgia, United States
+ 155 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Phoenix, Arizona, United States; Surprise, Arizona, United States; La Palma, California, United States; Long Beach, California, United States; Los Angeles, California, United States and 169 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.