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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

ARNASA 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.Check my eligibility
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.See study design
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.

ARNASA Trial Eligibility Criteria

Inclusion Criteria

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

ARNASA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart rate
Secondary outcome measures
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%
Hypokalaemia
7%
Anaemia
6%
Hypertension
5%
COVID-19 pneumonia
5%
Headache
5%
Hypotension
4%
Anxiety
3%
Dry skin
3%
Respiratory failure
2%
Gastric ulcer haemorrhage
2%
Atrial fibrillation
2%
Pneumonia
2%
Septic shock
2%
Multiple organ dysfunction syndrome
2%
Acute myocardial infarction
2%
COVID-19
2%
Acute kidney injury
2%
Hypoxia
2%
Nausea
2%
Pneumothorax
1%
Renal impairment
1%
Cardiac arrest
1%
Cardiac failure
1%
Oxygen saturation decreased
1%
Right ventricular dysfunction
1%
Left ventricular failure
1%
Liver injury
1%
Pneumonia bacterial
1%
Urinary tract infection
1%
Urosepsis
1%
Radius fracture
1%
Aspartate aminotransferase increased
1%
Hypernatraemia
1%
Uterine leiomyoma
1%
Toxic encephalopathy
1%
Confusional state
1%
Haematuria
1%
Acute respiratory failure
1%
Respiratory arrest
1%
Pleural effusion
1%
Pneumomediastinum
1%
Pneumonia aspiration
1%
Pulmonary embolism
1%
Respiratory distress
1%
Shock
1%
Shock haemorrhagic
100%
80%
60%
40%
20%
0%
Study treatment Arm
All Placebo
MSTT1041A
UTTR1147A

ARNASA 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

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,088,933 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
887,650 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 Q2W, Astegolimab SC Q4W
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research encompass participants of seventy five years and above?

"According to the selection criteria, participants must be between 40 and 80 years old. 35 studies are available for those under 18 while 469 studies target individuals above 65."

Answered by AI

To what extent is Astegolimab SC Q4W a risk-free treatment option?

"The safety of Astegolimab SC Q4W was rated a 3 due to the accumulated evidence from Phase 3 trials, verifying its efficacy and demonstrating that it is safe."

Answered by AI

Are there any vacancies available for participants in this research?

"Indeed, information found on clinicaltrials.gov confirms that this research is currently looking for participants. It was first published around December 30th 2022 and the most recent update occured a few days later on December 20th 2022. This experiment requires 1290 patients to be recruited from one medical centre."

Answered by AI

How extensive is the sample size for this research trial?

"Affirmative, the research listed on clinicaltrials.gov reveals that this scientific study is at present seeking volunteers. It was first posted in December 30th 2022 and has been most recently revised on December 20th 2022. The trial seeks to recruit 1290 individuals from a single site."

Answered by AI

Under what criteria can individuals partake in this experiment?

"This medical trial requires 1290 volunteers aged 40 to 80 with chronic obstructive airway disease. Furthermore, the enrolment criteria include: having a COPD diagnosis for one year or longer; 20-80% post-bronchodilator FEV1 of predicted value at screening; optimised maintenance therapy such as ICS plus LABA, LAMA plus LABA, and ICS plus LAMA plus LABA for twelve months prior to screening; mMRC score ≥2 ; history of smoking 10 pack-years or more; chest X-ray within 6 months before screening confirming absence of other lung diseases besides COPD;"

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
What site did they apply to?
AES - DRS - Synexus Clinical Research US, Inc. - Tucson
AES - DRS - Synexus Clinical Research US, Inc. - Vista
AES - DRS - Synexus Clinical Research US, Inc. - New York
Other

What questions have other patients asked about this trial?

How long is it? How much is this trial? How long trial body take ?? How long is the screening process?
PatientReceived 1 prior treatment
If I don't have transportation is their any way I can get help with that?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

On 2 inhaler’s. To help more people. Nothing had gotten better. See if there are any changes.
PatientReceived 1 prior treatment
Trilogy, Albuterol, and Brestry.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. AES - DRS - Synexus Clinical Research US, Inc. - New York: < 24 hours
  2. AES - DRS - Synexus Clinical Research US, Inc. - Atlanta: < 24 hours
  3. Synexus Clinical Research US, Inc. - Phoenix West: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 2 Days
~578 spots leftby Jun 2025