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Monoclonal Antibodies

Astegolimab for COPD (ARNASA Trial)

Verified Trial
Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you free from other lung diseases (e.x. you do not have asthma)
Were you diagnosed with COPD more than 1 year ago?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial

Summary

This trial will study if a new medicine can help treat COPD, a lung disease, and reduce worsening episodes in smokers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects of astegolimab may include reactions at the injection site, increased risk of infections due to immune system changes, fatigue, headache, and possible respiratory symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have any other lung diseases like asthma.
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I was diagnosed with COPD over a year ago.
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I have smoked at least 10 pack-years.
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I am 18 years old or older.
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I am using inhaled or nebulized medications for my COPD.
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I have had 2 or more severe COPD flare-ups in the last year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Heart rate
Secondary study objectives
Chronic Obstructive Airway Disease
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Chronic Obstructive Airway Disease
+3 more

Side effects data

From 2021 Phase 2 trial • 396 Patients • NCT04386616
8%
Constipation
7%
Anaemia
7%
Hypokalaemia
6%
Hypertension
5%
Headache
5%
COVID-19 pneumonia
5%
Hypotension
4%
Anxiety
3%
Dry skin
3%
Respiratory failure
2%
Pneumothorax
2%
Nausea
2%
Multiple organ dysfunction syndrome
2%
Acute kidney injury
2%
Hypoxia
2%
Atrial fibrillation
2%
Pneumonia
2%
Gastric ulcer haemorrhage
2%
Acute myocardial infarction
2%
COVID-19
2%
Septic shock
1%
Urinary tract infection
1%
Pneumomediastinum
1%
Shock haemorrhagic
1%
Urosepsis
1%
Liver injury
1%
Shock
1%
Pneumonia aspiration
1%
Respiratory arrest
1%
Cardiac failure
1%
Toxic encephalopathy
1%
Aspartate aminotransferase increased
1%
Renal impairment
1%
Pulmonary embolism
1%
Pneumonia bacterial
1%
Haematuria
1%
Left ventricular failure
1%
Cardiac arrest
1%
Pleural effusion
1%
Right ventricular dysfunction
1%
Uterine leiomyoma
1%
Confusional state
1%
Respiratory distress
1%
Radius fracture
1%
Oxygen saturation decreased
1%
Hypernatraemia
1%
Acute respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
MSTT1041A
UTTR1147A

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Astegolimab SC Q4WExperimental Treatment1 Intervention
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Group II: Astegolimab SC Q2WExperimental Treatment1 Intervention
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Group III: Placebo SC Q2WPlacebo Group1 Intervention
Participants will receive SC placebo Q2W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Astegolimab
2021
Completed Phase 2
~1440

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,456 Previous Clinical Trials
1,096,352 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,225 Previous Clinical Trials
895,100 Total Patients Enrolled

Media Library

Astegolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05595642 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Placebo SC Q2W, Astegolimab SC Q4W, Astegolimab SC Q2W
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Astegolimab Highlights & Side Effects. Trial Name: NCT05595642 — Phase 3
Astegolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05595642 — Phase 3
~267 spots leftby Jun 2025
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