Astegolimab for COPD

(ARNASA Trial)

Recruiting at 126 trial locations

Overseen By Reference Study ID Number: GB44332 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Hoffmann-La Roche

Must be taking: ICS, LABA, LAMA

Must not be taking: Oral corticosteroids

Disqualifiers: Asthma, Pulmonary disease, Heart failure, others

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: 12

Duration: 24 weeks

1290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called astegolimab for individuals with chronic obstructive pulmonary disease (COPD). The researchers aim to determine if astegolimab can reduce flare-ups and improve breathing. Participants will receive either the actual treatment or a placebo (a harmless pill or shot with no real medicine) to compare effects. The trial seeks former or current smokers who have had COPD for at least a year and experience frequent flare-ups. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for COPD.

Will I have to stop taking my current medications?

The trial requires that you stay on your current COPD maintenance therapy, which includes inhaled corticosteroids, long-acting beta-agonists, and long-acting muscarinic antagonists, for at least 4 weeks before screening. 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?

A previous study found astegolimab to be safe for patients with chronic obstructive pulmonary disease (COPD). The research showed no major safety concerns, indicating that serious side effects were uncommon. Another study found that astegolimab improved patients' overall health compared to a placebo, even though it did not significantly reduce the number of COPD flare-ups. This suggests that while the medicine might not prevent every flare-up, it helps patients feel better overall without causing harm. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Astegolimab is unique because it targets the IL-33 pathway, which plays a crucial role in inflammation related to chronic obstructive pulmonary disease (COPD). Most current treatments for COPD, like bronchodilators and corticosteroids, primarily focus on relieving symptoms and reducing inflammation generally. However, Astegolimab specifically aims to block IL-33, potentially offering more precise intervention in the inflammatory process. Researchers are excited about its potential to provide better control over COPD symptoms and possibly slow disease progression, offering a new avenue of hope for patients.

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

Research has shown that astegolimab is designed to block the ST2 receptor, which plays a role in inflammation. In past studies with individuals who have moderate-to-severe chronic obstructive pulmonary disease (COPD), astegolimab improved overall health compared to a placebo. However, it did not significantly reduce the number of COPD flare-ups. In this trial, participants will receive either astegolimab or a placebo to further evaluate its effectiveness. The treatment aims to manage symptoms by reducing airway inflammation. While earlier trials have shown some positive effects, the results on reducing flare-ups have been mixed. ^{2 4 6 7 8}

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 over 18 with COPD, diagnosed at least a year ago. Participants should be current or former smokers with a significant smoking history and have had multiple COPD flare-ups in the past year. They must be on standard COPD medications but free from other lung conditions like asthma.

Inclusion Criteria

I have had 2 or more severe COPD flare-ups in the last year.

I have smoked at least 10 pack-years.

I was diagnosed with COPD over a year ago.

Exclusion Criteria

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

24 weeks

12 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 is testing astegolimab against a placebo to see if it's more effective in treating people with chronic obstructive pulmonary disease (COPD) who smoke or used to smoke and often have exacerbations of their condition.

How Is the Trial Designed?

Group I: Astegolimab SC Q4W Experimental Treatment 1 Intervention

Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.

Group II: Astegolimab SC Q2W Experimental Treatment 1 Intervention

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

Group III: Placebo SC Q2W Placebo Group 1 Intervention

Participants will receive SC placebo Q2W

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

The IL-33/ST2 pathway is significantly involved in the inflammation and alveolar damage seen in COPD, with its expression linked to disease progression, highlighting a potential target for new therapies.

Current research includes the development of antibodies targeting IL-33 and ST2, with ongoing clinical trials exploring their efficacy in treating COPD, which could lead to novel treatment options beyond existing inhaled corticosteroids and bronchodilators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of IL-33/ST2 in COPD and Its Future as an Antibody Therapy. Riera-Martínez, L., Cànaves-Gómez, L., Iglesias, A., et al.[2023]

In a 24-week study involving 316 Japanese rheumatoid arthritis patients, certolizumab pegol (CZP) combined with methotrexate (MTX) showed significantly higher ACR20 response rates compared to placebo, indicating effective symptom relief.

CZP treatment not only reduced RA symptoms but also significantly inhibited joint damage progression and improved health-related quality of life, with a similar safety profile across all treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of certolizumab pegol plus methotrexate in Japanese rheumatoid arthritis patients with an inadequate response to methotrexate: the J-RAPID randomized, placebo-controlled trial. Yamamoto, K., Takeuchi, T., Yamanaka, H., et al.[2022]

In a study of 662 adults with moderate-to-severe Crohn's disease, certolizumab pegol showed a modest improvement in response rates compared to placebo, with 35% of patients responding at week 6 versus 27% in the placebo group.

While certolizumab pegol was effective in inducing a response, it did not significantly improve remission rates, and there were some safety concerns, including serious adverse events occurring in 10% of patients treated with certolizumab compared to 7% in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certolizumab pegol for the treatment of Crohn's disease. Sandborn, WJ., Feagan, BG., Stoinov, S., et al.[2022]

Pateclizumab, a humanized monoclonal antibody targeting lymphotoxin α, was found to be well-tolerated in rheumatoid arthritis patients, with no serious adverse events reported during the study involving both single and multiple ascending doses.

In the multiple ascending dose phase, patients receiving 3.0 mg/kg of pateclizumab showed significant clinical improvement, with 75% achieving ACR20 response rates, compared to 57% in the placebo group, indicating its potential efficacy in reducing disease activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial. Emu, B., Luca, D., Offutt, C., et al.[2023]

Dupilumab was found to be effective in treating chronic obstructive pulmonary disease (COPD) characterized by type 2 inflammation, as indicated by elevated eosinophil counts.

The study suggests that targeting type 2 inflammation with dupilumab could provide a new therapeutic approach for patients with COPD, potentially improving their respiratory function and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In COPD with type 2 inflammation despite inhaled triple therapy, dupilumab safely reduced exacerbations. Estrada, RA., Maselli, DJ., Anzueto, AR.[2023]

In a study involving 668 adults with moderate-to-severe Crohn's disease, those who received maintenance therapy with certolizumab pegol after an initial response were significantly more likely to maintain their response (62% vs. 34% for placebo) and achieve remission (48% vs. 29% for placebo) at 26 weeks.

Certolizumab pegol was effective regardless of concurrent treatments like glucocorticoids or immunosuppressants, but there were some safety concerns, including a 3% incidence of serious infections in the certolizumab group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance therapy with certolizumab pegol for Crohn's disease. Schreiber, S., Khaliq-Kareemi, M., Lawrance, IC., et al.[2022]

A 39-year-old man developed thrombotic microangiopathy after 6 months of treatment with certolizumab pegol for ankylosing spondylitis, highlighting a potential adverse effect of this medication.

The patient's condition improved significantly with plasma exchange and corticosteroids, suggesting that while certolizumab pegol is effective for treating certain autoimmune diseases, it can also lead to serious complications like thrombotic microangiopathy, which may be immune-mediated or due to dose-dependent toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Induced Thrombotic Microangiopathy with Certolizumab Pegol Baysal, M., Ümit, EG., Sarıtaş, F., et al.[2019]

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]

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]

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]

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

NCT03615040 | Anti-ST2 (MSTT1041A) in COPD ... Subgroup objectives: to evaluate the efficacy of anti-ST2 versus placebo on the outcome rate of protocol-defined COPD exacerbations through 48 weeks treatment ...

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

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

8. 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 ...