Long-Term Safety of Astegolimab for COPD

Recruiting at 567 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term safety of astegolimab for individuals with chronic obstructive pulmonary disease (COPD). Astegolimab is offered to those who completed a previous 52-week study and wish to continue. The trial's primary goal is to assess its safety and effectiveness in managing COPD symptoms. Individuals who completed the earlier study without major issues or new health problems, such as asthma or heart disease, may qualify for this trial. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new COPD treatment.

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.

Is there any evidence suggesting that astegolimab is likely to be safe for humans?

Research has shown that astegolimab, an anti-ST2 monoclonal antibody, has undergone safety testing in several studies. Earlier research indicated that astegolimab did not raise major safety concerns and was generally well tolerated, with few serious side effects. These studies involved participants with moderate-to-very severe COPD, and most did not report major problems.

One study found that astegolimab did not significantly reduce COPD flare-ups but did improve participants' overall health compared to a placebo. While it may not prevent flare-ups, it can still positively affect health.

These findings come from studies leading up to the current Phase 3 trial. A Phase 3 trial typically indicates that the treatment has been tested multiple times and is considered safe for larger groups. This phase aims to confirm its safety and effectiveness over a longer period. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for COPD?

Unlike the standard of care for COPD, which often includes bronchodilators and corticosteroids, astegolimab targets a different pathway by focusing on the immune response. Astegolimab is unique because it blocks the signaling of a protein called IL-33, which is involved in inflammation. Researchers are excited about astegolimab because it offers a novel approach to reducing inflammation, potentially leading to better management of COPD symptoms with fewer side effects than current treatments. Additionally, this treatment is administered subcutaneously every two weeks, providing a convenient option for patients.

What evidence suggests that astegolimab might be an effective treatment for COPD?

Research has shown that astegolimab can improve the health of people with moderate-to-very severe chronic obstructive pulmonary disease (COPD). While it may not significantly reduce flare-ups, it appears to enhance daily life for patients compared to a placebo. Astegolimab blocks a specific part of the body that causes airway inflammation, which is crucial because inflammation can worsen COPD symptoms. Although more information is needed to fully understand its effectiveness, these findings suggest that astegolimab could benefit people with COPD. ^{1 2 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03615040

Study Details | NCT03615040 | Anti-ST2 (MSTT1041A) in ... The main aim of this trial is to evaluate whether anti-ST2 will impact on airway inflammation in COPD and therefore reduce the frequency of exacerbations.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35339234/

Astegolimab, an anti-ST2, in chronic obstructive pulmonary ... In patients with moderate-to-very severe COPD, astegolimab did not significantly reduce exacerbation rate, but did improve health status compared with placebo.

3. gene.com gene.com/media/press-releases/15071/2025-07-20/genentech-provides-update-on-astegolimab

Genentech: Press Releases | Sunday, Jul 20, 2025 Astegolimab is an investigational, fully human anti-ST2 monoclonal antibody designed to bind with high affinity to the ST2 receptor, thereby ...

4. roche.com roche.com/investors/updates/inv-update-2025-07-21

[Ad hoc announcement pursuant to Art. 53 LR] ... [2] A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. [Internet; cited ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12574037/

Safety and tolerability of astegolimab, an anti-ST2 ... In COPD, it is proposed that astegolimab blocks the initiation of inflammation driven by ST2/IL-33 binding to prevent the onset of AECOPD.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41163220/

Safety and tolerability of astegolimab, an anti-ST2 ... Ongoing Phase IIb and Phase III trials of astegolimab in patients with COPD who have a history of frequent acute exacerbation(s) of COPD will ...

7. researchgate.net researchgate.net/publication/396128074_Safety_Pharmacokinetics_and_Immunogenicity_of_Astegolimab_an_Anti-ST2_Monoclonal_Antibody_in_Randomized_Phase_I_Clinical_Studies

(PDF) Safety, Pharmacokinetics, and Immunogenicity of ... Astegolimab was well tolerated in these Phase I studies with no safety concerns identified. Thus, further assessment of astegolimab in targeted ...