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

NCT07190222
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
942
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Lead sponsor
Sanofi
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Start date
2025-09-17
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Number of sites
314
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Summary
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.
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Acronym
THESEUS
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Short 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
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Official title
A Phase 2b/Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study, to Investigate the Efficacy and Safety of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2030-01-22
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First posted
2025-09-24
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Registry last updated
2026-10-23
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Primary completion date
2029-11-27
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Start date
2025-09-17
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Participants
942
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Participant count basis
Estimated
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Planned participants
942
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Protocol amendments
2
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Number of sites
314
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Sanofi
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07190222
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ClinicalTrials.gov ID
NCT07190222
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualized rate of moderate-to-severe chronic obstructive pulmonary disease (COPD) exacerbations

    Timeframe: From Baseline up to 48 weeks

    The annualized moderate or severe COPD exacerbation rate up to 48 weeks treatment period compared to placebo

  1. Change from baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)

    Timeframe: From Baseline up to 48 weeks

    The post-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

  2. Change from baseline in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1)

    Timeframe: From Baseline up to 48 weeks

    The pre-Bronchodilator Forced Expiratory Volume in 1 second is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.

  3. Change from baseline in the SGRQ-C total score

    Timeframe: From Baseline up to 48 weeks

    The St. George's Respiratory Questionnaire for patients with chronic obstructive pulmonary disease is derived from the St. George's Respiratory Questionnaire (SGRQ) and is designed to measure and quantify health status in adult patients with chronic airflow limitation. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.

  4. SGRQ responder defined as an improvement of ≥4 points in the SGRQ-C total score

    Timeframe: From Baseline up to 48 weeks

  5. Change from baseline in the Chronic airways assessment Test (CAAT) score

    Timeframe: From Baseline up to 48 weeks

    The CAAT is an 8-item patient-reported outcome (PRO) measure designed to assess the impact of chronic airways diseases, including COPD, on patients' health status. The CAAT has a scoring range of 0-40, with higher scores indicating a greater impact of the disease on health status.

  6. CAAT responder defined as an improvement of ≥2 points in the CAAT total score

    Timeframe: From Baseline up to 48 weeks

  7. Change from baseline in the E-RS:COPD total score

    Timeframe: From Baseline up to 48 weeks

    The Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) is an 11-item patient-reported outcome (PRO) measure that evaluates the severity of respiratory symptoms in patients with stable COPD. The total score ranges from 0 to 40, with higher scores indicating more severe respiratory symptoms.

  8. E-RS:COPD responder defined as an improvement of ≥2 points in the E-RS:COPD total score

    Timeframe: From Baseline up to 48 weeks

  9. Annualized rate of severe COPD exacerbations

    Timeframe: From Baseline up to 48 weeks

  10. Time to first moderate or severe COPD exacerbation

    Timeframe: From Baseline up to 48 weeks

    Time to first occurrence of moderate to severe COPD exacerbation up to 48 weeks

  11. Time to first severe COPD exacerbation

    Timeframe: From Baseline up to 48 weeks

    Time to first occurrence of severe COPD exacerbation up to 48 weeks

  12. Incidence of participants with TEAEs, including AESIs, and SAEs

    Timeframe: From Baseline up to 56 weeks

    Treatment-Emergent Adverse Events (TEAEs), Adverse events of Special Interest (AESIs), Serious Adverse Events (SAEs)

  13. Incidence of potentially clinically significant laboratory abnormalities

    Timeframe: From Baseline up to 56 weeks

  14. Serum concentration of lunsekimig

    Timeframe: From Baseline up to 48 weeks

  15. Incidence and titer of antidrug antibodies (ADAs)

    Timeframe: From Baseline up to 48 weeks

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No

  • 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 in a clinical trial.

Sources for eligibility
clinicaltrials.gov

  • University of Alabama at Birmingham- Site Number : 8400003Birmingham, United StatesRecruiting
  • Pulmonary Associates - Mobile- Site Number : 8400151Mobile, United StatesRecruiting
  • Tucson Clinical Research Institute- Site Number : 8400006Tucson, United StatesRecruiting
  • Ark Clinical Research- Site Number : 8400113Long Beach, United StatesRecruiting
  • Inglewood Clinical- Site Number : 8400074Los Angeles, United StatesRecruiting
  • Alliance Clinical - West Hills- Site Number : 8400067Los Angeles, United StatesRecruiting
  • California Medical Research Associates - Northridge- Site Number : 8400089Northridge, United StatesRecruiting
  • Acclaim Clinical Research- Site Number : 8400068San Diego, United StatesCompleted
  • Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8400005Boulder, United StatesRecruiting
  • Critical Care Pulmonary & Sleep Associates- Site Number : 8400081Lakewood, United StatesRecruiting
  • Howard University Hospital- Site Number : 8400080Washington D.C., United StatesRecruiting
  • Meris Clinical Research- Site Number : 8400153Brandon, United StatesRecruiting
  • Hillcrest Medical Research- Site Number : 8400082DeLand, United StatesRecruiting
  • Finlay Medical Research - Greenacres- Site Number : 8400107Greenacres City, United StatesRecruiting
  • Direct Helpers Research Center- Site Number : 8400057Hialeah, United StatesRecruiting
  • University of Florida - Jacksonville- Site Number : 8400126Jacksonville, United StatesRecruiting
  • Salud Clinical Services- Site Number : 8400109Lehigh Acres, United StatesRecruiting
  • Pulmonary Specialists of the Palm Beaches- Site Number : 8400017Loxahatchee Groves, United StatesRecruiting
  • Elite Clinical Research - Miami- Site Number : 8400167Miami, United StatesRecruiting
  • DL Research Solutions- Site Number : 8400140Miami, United StatesRecruiting
  • Phoenix Medical Research - Miami - 24th Street- Site Number : 8400027Miami, United StatesRecruiting
  • Professional Research Center- Site Number : 8400046Miami, United StatesRecruiting
  • Research Institute of South Florida- Site Number : 8400028Miami, United StatesRecruiting
  • Innovations Biotech- Site Number : 8400019Miami, United StatesRecruiting
  • Heuer M.D. Research- Site Number : 8400018Orlando, United StatesRecruiting

And 289 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2024-518213-25-00
  • U1111-1308-9980
Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)