Astegolimab for Chronic Obstructive Pulmonary Disease

No longer recruiting at 254 trial locations

Overseen By Reference Study ID Number: GB43311 www.roche.com/about_roche/roche_worldwide.htm

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Genentech, Inc.

Must be taking: ICS, LABA, LAMA

Must not be taking: Oral corticosteroids

Disqualifiers: Asthma, Pulmonary disease, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called astegolimab for people with chronic obstructive pulmonary disease (COPD). The study aims to evaluate the effectiveness and safety of astegolimab when used alongside standard COPD treatments. Participants will receive either astegolimab (an experimental treatment) every two or four weeks, or a placebo. This trial suits current or former smokers who have had COPD for over a year and frequently experience flare-ups (two or more in the last two years). As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in COPD treatment.

Will I have to stop taking my current medications?

The trial requires you to stay on your current COPD maintenance therapy without changes before and during the study. If you are on other medications, the protocol does not specify if you need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that astegolimab is generally safe for individuals with chronic obstructive pulmonary disease (COPD). Although it may not significantly reduce the number of COPD flare-ups, it has improved overall health compared to a placebo. Most side effects are mild to moderate, and serious side effects are rare. These findings suggest that astegolimab is relatively safe, though further studies are underway to confirm these results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for Chronic Obstructive Pulmonary Disease (COPD), which often include bronchodilators and inhaled corticosteroids, astegolimab targets the interleukin-33 pathway, a novel mechanism believed to play a role in airway inflammation. This bi-weekly or monthly subcutaneous injection offers a new delivery method compared to the typical inhaled or oral medications. Researchers are excited about astegolimab because it could potentially reduce inflammation more effectively, providing better management of COPD symptoms and improving patients' quality of life.

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

In this trial, participants will receive either astegolimab or a placebo. Previous studies found that astegolimab did not significantly reduce the number of COPD flare-ups compared to a placebo. However, it improved patients' overall health. Research shows that astegolimab targets the ST2 pathway, believed to be involved in inflammation related to COPD. This targeting might help manage some COPD symptoms, even if it doesn’t reduce flare-ups. Experts see potential benefits, but more detailed data is needed to confirm its effectiveness in reducing flare-ups. ^{1 2 4 5 6}

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 adults with COPD who smoke or used to smoke, have had frequent flare-ups, and are on stable lung medication. They must not have other significant lung diseases, recent respiratory infections or hospitalizations, unstable heart conditions, or be starting new pulmonary treatments.

Inclusion Criteria

I've had 2 or more severe health flare-ups in the last year.

I often feel short of breath when moving around.

I have been on a stable COPD treatment plan for at least 4 weeks.

Exclusion Criteria

I am enrolled or planning to enroll in a lung rehab program.

I have been on oxygen therapy using more than 4 liters per minute for a long time.

I have had a lung transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous astegolimab or placebo every 2 or 4 weeks in combination with standard COPD maintenance therapy

12 weeks

6 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
• Placebo

Trial Overview The study tests Astegolimab's effectiveness and safety in combination with standard COPD care versus a placebo. It aims to see if this treatment can help reduce the number of severe breathing problems (exacerbations) in people with COPD.

How Is the Trial Designed?

Group I: Astegolimab Q4W Experimental Treatment 1 Intervention

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).

Group II: Astegolimab Q2W Experimental Treatment 1 Intervention

Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).

Group III: Placebo Placebo Group 1 Intervention

Participants will receive SC placebo Q2W.

Who Is Running the Clinical Trial?

Genentech, Inc.

Lead Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Published Research Related to This Trial

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]

In a phase 2a trial involving patients with moderate-to-very severe COPD, astegolimab did not significantly reduce the rate of exacerbations compared to placebo, indicating limited efficacy in preventing acute worsening of the disease.

However, astegolimab was associated with improved health status as measured by the Saint George's Respiratory Questionnaire, suggesting potential benefits in quality of life despite not affecting exacerbation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Astegolimab, an anti-ST2, in chronic obstructive pulmonary disease (COPD-ST2OP): a phase 2a, placebo-controlled trial. Yousuf, AJ., Mohammed, S., Carr, L., et al.[2023]

Monoclonal antibody (mAB) therapies have a moderate effect on reducing the risk of exacerbations in chronic obstructive pulmonary disease (COPD), but they do not significantly improve lung function (FEV1) or quality of life (SGRQ).

In eosinophilic COPD patients, the IL-5 antagonist mepolizumab was found to reduce exacerbation risk, while benralizumab showed effectiveness in improving both lung function and quality of life, highlighting the potential of targeting IL-5 pathways in specific patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging biological therapies for treating chronic obstructive pulmonary disease: A pairwise and network meta-analysis. Rogliani, P., Matera, MG., Puxeddu, E., et al.[2019]

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]

In two phase 3 trials involving patients with chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype, mepolizumab (100 mg) significantly reduced the annual rate of moderate or severe exacerbations compared to placebo, particularly in patients with higher blood eosinophil counts.

The safety profile of mepolizumab was comparable to that of placebo, indicating that it is a safe treatment option for reducing exacerbations in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab for Eosinophilic Chronic Obstructive Pulmonary Disease. Pavord, ID., Chanez, P., Criner, GJ., et al.[2022]

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]

A subset of patients with chronic obstructive pulmonary disease (COPD) who have elevated blood eosinophils may benefit from biologic treatments like mepolizumab, which targets eosinophilic inflammation.

Mepolizumab, a monoclonal antibody against interleukin-5 (IL-5), has shown potential therapeutic effects in these patients, particularly in those who do not respond adequately to standard inhaled corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease. Mkorombindo, T., Dransfield, MT.[2020]

Citations

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

NCT03615040 | Anti-ST2 (MSTT1041A) in COPD ... To evaluate the efficacy of anti-ST2 versus placebo on the outcome rate of protocol-defined COPD exacerbations through 48 weeks treatment period, patient ...

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 Genentech Provides Update on Astegolimab in Chronic Obstructive Pulmonary Disease. The pivotal Phase IIb ALIENTO study met the primary ...

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. sigma.larvol.com sigma.larvol.com/moa.php?e1=971864&tab=OTTtrac&sourcepg=TZMoa

ST2 inhib Trials NCT05037929 / 2021-002045-15: A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease. Completed.

6. respiratory-research.biomedcentral.com respiratory-research.biomedcentral.com/articles/10.1186/s12931-025-03360-0

Safety and tolerability of astegolimab, an anti-ST2 monoclonal ... This narrative review summarizes clinical safety data from published clinical trials of astegolimab with a focus on adverse events of interest, ...