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Phase 2 Study - High-Risk Asthma (Not Currently Eligible for Biologics)

Objective: For patients on medium-dose ICS/LABA not currently eligible for biologic treatment. Investigates lunsekimig subcutaneous injection.

Key Requirements: Eos ≥ 300, FeNO ≥ 50, ≥1 exacerbation last year. (Excludes recent biologic use)

Phase 3b Study - Open-Label IL-5 Biologic with CT Imaging

Objective: Open-label (no placebo) study assessing CT changes over 1 year after receiving the IL-5 biologic depemokimab (dosed every 6 months).

Key Requirements: Eos ≥ 300, ≥2 exacerbations, on medium/high ICS + another controller. (Excludes prior anti-IL-5/biologic use)

Phase 2 Study - New Anti-TSLP Antibody

Objective: Dose-finding study for a new Anti-TSLP Antibody (dosed every 6 months).

Key Requirements: Adults with ≥1 exacerbation last year on medium/high ICS + another controller. (Excludes recent biologic use)

ACT18301 (AIRLYMPUS) - Phase 2

Objective: 52-week study of lunsekimig (SAR443765) subcutaneous injection for high-risk asthma not currently eligible for biologic treatment

Key Inclusion Criteria:

• Age: 18-80 years
• Maintenance with ICS dose < 500 μg/day of fluticasone propionate or comparable
• At least 1 asthma exacerbation in the year prior to screening
• Eos > 300 at screening
• FeNO > 50 ppb at screening
• Documented reversibility or positive bronchoprovocation test

Key Exclusions: Recent biologic therapy, NO LAMA USE IN ADDITION TO ICS/LABA

GSK IMAGINE - Depemokimab IL5 (Phase 3b)

Objective: 52-week open-label study (no placebo) assessing CT changes using HRCT after biologic treatment

Key Inclusion Criteria:

• Age > 18 years
• Absolute eos > 300 and > 2 exacerbations
• FeNO > 25 ppb at screening
• Medium or high dose ICS > 12 months + 1 additional controller
• Extra substudy option with bronchoscopy sampling

Key Exclusions: Prior anti-IL-5/5R therapy, other biologics within 12 months, NO METAL OBJECTS (pacemaker, prosthesis) due to CT scan

GSK223125 (NAZARE) - Phase 2

Objective: 52-week anti-TSLP antibody study (dosed every 6 months!)

Key Features: No FeNO needed - patients randomized based on FeNO levels < 25 ppb or > 25 ppb

Key Inclusion Criteria:

• Age: 18-75 years
• Diagnosed with asthma > 2 years
• At least 1 exacerbation within 12 months prior
• On medium or high dose ICS + 1 other controller

Phase 3/4 Study - COPD with Cardiovascular Risk

Objective: For patients aged 40-80 with COPD & cardiovascular risk/disease, comparing BREZTRI vs. BEVESPI. Primary goal: Reduce cardiac events (MI/CVA).

Key Requirements: Eos ≥ 100. Key Exclusion: Cannot have used ICS for more than 2 months in the past year.

Phase 2b/3 Study - Moderate to Very Severe COPD

Objective: For patients with high exacerbation risk (≥2 moderate or ≥1 severe in past year) on triple therapy. Investigates Lunsekimig (novel NANOBODY) targeting IL-13 and TSLP.

Key Requirements: Eos ≥ 150.

Phase 4 Study - Open-Label Dupixent for COPD

Objective: Open-label (no placebo - all participants get Dupixent). For COPD patients qualifying for Dupixent (Eos ≥ 300, ≥2 exacerbations). Assesses CT changes (mucus plugging).

Phase 1b Study - GSK IL-33 Antibody

Objective: Safety study (no placebo) for a GSK IL-33 antibody. For COPD patients aged 40-75 with Eos ≥ 150. Pays ~$150/visit.

Phase 3 Study - IL-5 Biologic for COPD

Objective: For COPD exacerbators with TH2 inflammation or eosinophilia. Investigates the IL-5 biologic depemokimab.

THARROS Study (Phase 3/4)

Objective: Reduction in Cardiac Events (MI and CVA) with BREZTRI vs. BEVESPI in patients with COPD not on Inhaled Corticosteroids more than 2 months in last year.

Key Inclusion Criteria:

• Age: 40-80 years
• COPD diagnosis: Post-bronchodilator FEV1/FVC ratio < 70%
• Smoking history: ≥ 10 pack-years (current or former smokers)
• Blood eosinophil count: ≥ 100 cells/mm³
• CAT score: ≥ 10 (phlegm and cough items ≥ 2 each)
• Cardiovascular (CV) criteria (must meet at least one):
  • Established CV disease e.g. stent, prior MI (min. 50% of participants)
  • Combination of 3 out of 5 CV risk factors
  • High CV risk score on validated assessment tool
  • Significant coronary artery calcification with additional risk factor

EFC18243/EFC18244 - Lunsekimig in COPD (Phase 2b/3)

Objective: Investigate Lunsekimig (Novel NANOBODY) targeting both IL-13 and TSLP inhibition for moderate to very severe COPD.

Key Inclusion Criteria:

• Age: 40-80 years
• BMI: 18.0-40.0 kg/m² (or <18.0 kg/m² if weight >40 kg)
• Moderate to very severe COPD (diagnosed ≥12 months prior)
• Post-bronchodilator FEV1 ≥20% and ≤70% predicted
• Smoking history ≥10 pack-years
• CAT score ≥10
• High exacerbation risk: ≥2 moderate OR ≥1 severe exacerbation in past year
• On triple therapy (LABA+LAMA+ICS) for ≥3 months
• Blood eosinophils ≥150 cells/μL at screening

Key Exclusions: Asthma diagnosis, oxygen requirement >4.0 L/min, recent AECOPD

PRESTO Study - IRAK4 Inhibitor for COPD

Objective: Revolutionary IRAK4 pathway targeting for chronic inflammation in COPD, potentially reducing exacerbations and improving disease control.

Key Inclusion Criteria:

• Age ≥40 years
• Documented moderate to very severe COPD for ≥12 months
• Stable regimen of triple or dual therapy for ≥3 months
• Exacerbation history: ≥2 moderate or ≥1 severe COPD exacerbation(s) in past 12 months

Key Exclusions: Other lung diseases (asthma, bronchiectasis, fibrosis), left heart failure, active TB

GSK221531 - COPD Phase 1B IL33 Antibody

Objective: 52-week safety study (patients receive approximately $150 per visit)

Key Inclusion Criteria:

• Age: 40-75 years
• Body weight 50-110 kg, BMI 19.5-32 kg/m²
• Confirmed COPD diagnosis for >12 months
• Post-bronchodilator FEV1/FVC ratio <0.70 and FEV1 ≥40% predicted
• Blood eosinophil count ≥150 cells/μL
• Male participants or females of non-childbearing potential only

GSK 222714 ENDURA 1 - IL-5 Depemokimab

Objective: For COPD exacerbators with TH2 inflammation or eosinophilia

Contact: Frank Hull MD or Edric Caampued, PA

Phase 3 Study - Refractory or Unexplained Chronic Cough

Objective: For Refractory or Unexplained Chronic Cough (RCC/UCC) lasting ≥ 1 year, unresponsive to standard treatments. Investigates the P2X3 inhibitor camlipixant.

Key Requirements: Cough Severity VAS ≥ 40 required.

Key Exclusions: Current smokers or recent quitters (<6 months), significant respiratory diseases (COPD, IPF, Bronchiectasis), uncontrolled asthma.

CALM2 Chronic Cough Study

Objective: Investigate CAMLIPIXANT P2X3 Inhibitor for Chronic Refractory Cough/Neuropathic Cough

Key Inclusion Criteria:

• Age: 18-80 years
• Persistent cough for ≥ 1 year prior to screening
• Diagnosis of Refractory/Unexplained Chronic Cough (RCC/UCC)
• Cough Severity VAS ≥ 40 mm at screening and Day 1
• Chest X-ray or CT thorax within 5 years showing no significant abnormality

Key Exclusions:

• Current smoker or quit < 6 months ago
• 20 pack-year smoking history
• Diagnosis of COPD, bronchiectasis, IPF, or other significant respiratory disorders
• Uncontrolled asthma