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Monoclonal Antibodies

Long-Term Safety of Astegolimab for COPD

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
Completion of the 52-week treatment period in either parent GB43311 or GB44332
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks after last dose of study treatment
Awards & highlights

Study Summary

This trial will study the long-term safety and efficacy of astegolimab for COPD patients who have completed prior studies.

Who is the study for?
This trial is for people with chronic obstructive pulmonary disease (COPD) who completed a previous 52-week study of Astegolimab. They can't join if they've developed asthma, other significant lung diseases, serious heart conditions, or had non-compliance issues in the earlier study.Check my eligibility
What is being tested?
The trial is looking at the long-term safety and potential benefits of Astegolimab for COPD patients who were part of prior studies. It continues to monitor those who already received the drug for another year.See study design
What are the potential side effects?
While specific side effects are not listed here, long-term trials like this one typically watch for any new or worsening symptoms related to the lungs, heart, immune system reactions, and general health concerns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I completed a 52-week treatment in a specific clinical trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks after last dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks after last dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of all adverse events (AEs)

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

1Treatment groups
Experimental Treatment
Group I: Open-Label ExtensionExperimental Treatment1 Intervention
Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,088,161 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
886,878 Total Patients Enrolled

Media Library

Astegolimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05878769 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Open-Label Extension
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Astegolimab Highlights & Side Effects. Trial Name: NCT05878769 — Phase 3
Astegolimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05878769 — Phase 3

Frequently Asked Questions

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

Are potential participants still able to join this research endeavor?

"Affirmative. According to clinicaltrials.gov, this scientific study which was initially posted on June 28th 2023 is still actively recruiting participants. The trial aims to enlist 2000 people from 5 distinct medical centres."

Answered by AI

Am I eligible to partake in this research experiment?

"To meet the criteria of this clinical trial, individuals must have a confirmed diagnosis of chronic obstructive pulmonary disease and be between 40 to 90 years old. Approximately 2000 people are eligible for participation."

Answered by AI

Does this research endeavor have an age limit for prospective participants?

"The current clinical trial is exclusively accessible to persons aged 40-90. Additionally, there are 38 trials for minors and 486 studies catered towards seniors over 65 years old."

Answered by AI

What is the current federal regulatory stance on Open-Label Extension?

"The Open-Label Extension was rated a 3 on our team's scale, in recognition of the existing evidence for its efficacy and safety that has been produced through Phase 3 trials."

Answered by AI

In which locations can participants access this research?

"This clinical trial is presently running at 5 sites, located in Troy, Gastonia, Winston-Salem and two other cities. To reduce any travel hardships that may arise from enrollment, selecting the closest clinic is recommended."

Answered by AI

How many participants are in this experiment?

"Hoffmann-La Roche, the trial sponsor, has to recruit 2000 eligible participants across two sites in Troy Michigan and Gastonia North carolina respectively. The Oakland Medical Research Centre and Clinical Research of Gastonina will be coordinating this large scale medical experiment."

Answered by AI

Who else is applying?

What site did they apply to?
Revive Research Institute
OK Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
2023. "A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05878769.
All > Copd
~1333 spots leftby Jun 2027
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