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Astegolimab for Chronic Obstructive Pulmonary Disease

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 52
Awards & highlights

Study Summary

This trial will test if adding astegolimab to standard COPD maintenance therapy can reduce exacerbations in patients with a history of them.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of Astegolimab aren't listed here, similar medications may cause immune reactions, fatigue, digestive issues and increase infection risk. The trial will closely monitor participants for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've had 2 or more severe health flare-ups in the last year.
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I've had 2 or more severe health flare-ups in the last year.
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I have been on a stable COPD treatment plan for at least 4 weeks.
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I often feel short of breath when moving around.
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I have been diagnosed with COPD for at least a year.
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I have smoked at least 10 packs of cigarettes a year.
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I have smoked at least 10 pack-years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 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
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period
Secondary outcome measures
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52
Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52
Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score
+4 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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Astegolimab Q4WExperimental Treatment1 Intervention
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
Group II: Astegolimab Q2WExperimental Treatment1 Intervention
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive SC placebo Q2W.

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
566,313 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,151 Total Patients Enrolled

Media Library

Astegolimab Clinical Trial Eligibility Overview. Trial Name: NCT05037929 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Astegolimab Q2W, Astegolimab Q4W, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Astegolimab Highlights & Side Effects. Trial Name: NCT05037929 — Phase 2
Astegolimab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05037929 — Phase 2

Frequently Asked Questions

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

Does my profile meet the criteria for participation in this experiment?

"This trial aims to admit 930 individuals between the ages of 40 and 90 who suffer from obstructed airflow due to chronic obstructive pulmonary disease (COPD). Additional criteria for participation include: a physician diagnosis, exacerbation history within 24 months prior to screening, post-bronchodilator FEV1 measurement that is above 20% but below 80%, an mMRC score of 2 or greater, smoking status with at least 10 pack years under their belt, and optimized standard-of-care COPD maintenance therapy for four weeks."

Answered by AI

Could you provide an overview of the previous investigations conducted on Astegolimab?

"Presently, Astegolimab is being trialed in 1 clinical study. However, none of these trials are at the last stage (Phase 3). With 256 locations globally taking part in this research effort and the majority based out of Tel Aviv-Yafo and Texas."

Answered by AI

Does this research accommodate geriatric individuals?

"This medical trial has an age limit of 40 to 90 years old for enrollees. For those below the age requirement, there are 34 studies available and 461 alternative options accessible for individuals beyond the upper threshold."

Answered by AI

Are there any current opportunities for enrolment in this medical trial?

"Affirmative. The clinicaltrials.gov website reveals that this medical trial, initially posted on October 5th 2021, is actively enrolling participants. In total, 71 sites are trying to recruit 930 patients for the study."

Answered by AI

Is this medical trial a pioneering effort in its field?

"Presently, Astegolimab is the subject of one active study in 25 nations and 80 cities. This investigation, spearheaded by Genentech Inc., first commenced in 2021 with 930 participants and achieved Phase 2 approval status. Since then 18328 studies have been conducted."

Answered by AI

How many medical establishments are offering this clinical trial?

"Presently, this medical trial is being conducted out of 71 locations spread throughout the United States. Some prominent sites include Little Rock, Redding and Hannibal. To minimize travel requirements it's recommended to select a clinic close to you if you choose to enroll in the study."

Answered by AI

How many individuals are receiving treatment as part of this trial?

"This clinical trial needs 930 applicants who meet the designated criteria to participate. Potential patients can join at Atria Clinical Research - Clinedge - PPDS in Little Rock, Arkansas or Paradigm Clinical Research Institute Inc - ClinEdge-PPDS located in Redding, California."

Answered by AI

Has the FDA authorized utilization of Astegolimab for medical procedures?

"The safety profile of astegolimab has been assigned a score of 2, as there is some data in support of its security but no evidence to suggest efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Arkansas
Florida
Texas
Other
How old are they?
18 - 65
What site did they apply to?
Jasper Summit Research LLC
University of Florida College of Medicine Jacksonville
Other
Sherman Clinical Research - ClinEdge - PPDS
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1

How responsive is this trial?

Typically responds via
Phone Call
~341 spots leftby Jan 2025