Long-Term Safety of Astegolimab for COPD

Recruiting at 426 trial locations

Overseen By Reference Study ID Number: GB43374 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Disqualifiers: Asthma, Pulmonary fibrosis, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

2000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing astegolimab, a medication for COPD, in people who have already completed a previous study. The goal is to see if it is safe and effective over a longer period by reducing lung inflammation to improve breathing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Astegolimab for COPD?

Astegolimab has shown effectiveness in patients with severe asthma by reducing asthma exacerbation rates and improving lung function at higher doses, suggesting potential benefits for similar respiratory conditions like COPD. ^{1 2 3 4 5}

How is the drug Astegolimab unique for treating COPD?

Astegolimab is unique because it is a monoclonal antibody that targets the ST2 receptor, blocking interleukin-33 signaling, which is different from most COPD treatments that focus on bronchodilation or anti-inflammatory effects. This mechanism is novel for COPD, as it was previously studied in severe asthma, suggesting a different approach to managing respiratory conditions. ^{1 3 4 6 7}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

This trial is for people with chronic obstructive pulmonary disease (COPD) who completed a previous 52-week study of Astegolimab. They can't join if they've developed asthma, other significant lung diseases, serious heart conditions, or had non-compliance issues in the earlier study.

Inclusion Criteria

I completed a 52-week treatment in a specific clinical trial.

Exclusion Criteria

I have been diagnosed with asthma based on recognized guidelines since joining the main study.

I haven't had new heart issues or a heart attack since joining the main study.

I have not developed any new significant lung conditions other than COPD since joining the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label extension

Participants receive subcutaneous astegolimab every 2 weeks to assess long-term safety and efficacy

Until the end of the study

Bi-weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Astegolimab

Trial Overview The trial is looking at the long-term safety and potential benefits of Astegolimab for COPD patients who were part of prior studies. It continues to monitor those who already received the drug for another year.

Participant Groups

Group I: Open-Label Extension Experimental Treatment 1 Intervention

Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

Astegolimab, a monoclonal antibody targeting the ST2 receptor, was evaluated in a phase 2b study involving 368 patients with uncontrolled severe asthma, showing typical pharmacokinetic behavior for monoclonal antibodies.

The study found that the highest tested dose of 490 mg every 4 weeks approached maximum efficacy, indicating that increasing the dose further may not yield additional benefits in reducing asthma exacerbations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Relationships of Astegolimab in Patients With Severe Asthma. Kotani, N., Dolton, M., Svensson, RJ., et al.[2022]

A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.

The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. Zapata, E., Mennecier, B., Leduc, C., et al.[2017]

In the phase Ib KEYNOTE-001 study, pembrolizumab monotherapy showed durable antitumor activity in advanced non-small-cell lung cancer (NSCLC), with a median overall survival (OS) of 22.3 months for treatment-naive patients and 10.5 months for previously treated patients, and 5-year OS rates of 23.2% and 15.5%, respectively.

Patients with a PD-L1 tumor proportion score of 50% or greater had even better outcomes, with 5-year OS rates of 29.6% for treatment-naive and 25.0% for previously treated patients, while the treatment maintained a favorable safety profile with minimal late-onset adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. Garon, EB., Hellmann, MD., Rizvi, NA., et al.[2022]

Tezepelumab, a monoclonal antibody approved for severe uncontrolled asthma, significantly improved forced expiratory volume (FEV1) by 0.15 L and reduced asthma exacerbation rates by 0.60 per year compared to placebo, based on a meta-analysis of six trials with 2667 patients.

The treatment was found to have an acceptable safety profile, with no higher incidence of adverse drug reactions compared to placebo, indicating it is a safe option for patients with severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab for Patients with Severe Uncontrolled Asthma: A Systematic Review and Meta-Analysis. Zoumot, Z., Al Busaidi, N., Tashkandi, W., et al.[2022]

Pembrolizumab, an anti-PD-1 antibody, is effective as a first-line treatment for advanced nonsmall cell lung cancer (NSCLC) in patients with high PD-L1 expression (≥50%) and as a second-line option for those with lower PD-L1 expression (≥1%).

When combined with standard chemotherapy, pembrolizumab has demonstrated superior clinical outcomes compared to chemotherapy alone in patients with advanced NSCLC without targetable mutations, regardless of their PD-L1 expression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of nonsmall cell lung cancer: Current status and future directions. Qin, Q., Li, B.[2020]

In a 52-week study involving 65 Japanese patients with severe uncontrolled asthma, tezepelumab was found to be safe and well-tolerated, with most adverse events being mild to moderate, and only one case leading to treatment discontinuation.

Tezepelumab significantly reduced asthma exacerbation rates (0.11 per patient-year) and improved lung function and asthma control, with a 71.4% responder rate at Week 52, indicating its efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study. Shinkai, M., Ebisawa, M., Fukushima, Y., et al.[2023]

Tezepelumab, a monoclonal antibody for severe asthma, showed an acceptable safety profile in a phase 1 study with 24 healthy Japanese men, with no serious adverse events reported and no participants developing antibodies against the drug.

The pharmacokinetics of tezepelumab demonstrated linear absorption and a long half-life of approximately 24 days, indicating it is well-tolerated and may provide sustained therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men. Sakamoto, K., Matsuki, S., Irie, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Population Pharmacokinetics and Exposure-Response Relationships of Astegolimab in Patients With Severe Asthma. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Tezepelumab for Patients with Severe Uncontrolled Asthma: A Systematic Review and Meta-Analysis. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Pembrolizumab for the treatment of nonsmall cell lung cancer: Current status and future directions. [2020]

6. England pubmed.ncbi.nlm.nih.gov

One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men. [2022]