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Monoclonal Antibodies
Depemokimab for Nasal Polyps (ANCHOR-2 Trial)
Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants with 18 years of age and older inclusive, at the time of signing the informed consent.
Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to screening.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and from week 49 to week 52
Awards & highlights
ANCHOR-2 Trial Summary
This trial will study whether a new drug, called depemokimab, is effective and safe in people with CRSwNP.
Who is the study for?
Adults with chronic rhinosinusitis and nasal polyps who've had previous treatments like surgery or steroids, but still have severe symptoms. They must be using nasal corticosteroids for at least 8 weeks before the trial. Excluded are those with conditions like cystic fibrosis, vasculitis, recent radiation exposure, certain past drug studies, pregnancy, uncontrolled diseases, recent sinus infections or surgeries.Check my eligibility
What is being tested?
The trial is testing Depemokimab (GSK3511294), a new medication against a placebo to see if it's effective and safe in treating chronic rhinosinusitis with nasal polyps. Participants will randomly receive either the medication or a placebo for comparison.See study design
What are the potential side effects?
Possible side effects of Depemokimab may include allergic reactions to its components or general side effects common to monoclonal antibodies which can range from mild injection site reactions to more serious immune-related issues.
ANCHOR-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been using nasal steroid sprays or washes daily for at least 8 weeks.
ANCHOR-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and from week 49 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and from week 49 to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in mean nasal obstruction score using verbal response scale (VRS) from Weeks 49 to 52 (scores on a scale)
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 (scores on a scale)
Secondary outcome measures
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score (scores on a scale)
Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score (scores on a scale)
Nose
+4 moreANCHOR-2 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants receiving depemokimab (GSK3511294)Experimental Treatment1 Intervention
Group II: Participants receiving PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,566 Total Patients Enrolled
7 Trials studying Nasal Polyps
1,010 Patients Enrolled for Nasal Polyps
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,680 Total Patients Enrolled
5 Trials studying Nasal Polyps
995 Patients Enrolled for Nasal Polyps
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe nasal problems, including congestion, loss of smell, or a runny nose.I haven't had any nose or sinus surgery in the last 6 months, except for a nasal biopsy.I have a condition that increases my eosinophil levels, like EGPA or Eosinophilic Esophagitis.I have had a parasitic infestation in the last 6 months.My liver tests are abnormal, and I may have serious liver issues.I do not have a current diagnosis of vasculitis.I have been cancer-free for less than a year.I was hospitalized for asthma within the last month.I have had symptoms like nasal blockage and loss of smell for over 12 weeks.I have not had nose surgery that changed the structure of my nose's side walls.I have been using nasal steroid sprays or washes daily for at least 8 weeks.I have not been in a study with mepolizumab, reslizumab, or benralizumab in the last year.I have a tumor in my nasal cavity.I have an immune system disorder not caused by my asthma medication.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have a serious health condition that isn't managed well with treatment.I am 18 years old or older.I am a man or a woman eligible for this trial.I have had nasal surgery, used steroids for nasal polyps, or can't tolerate steroids.I have a severe blockage in one nostril due to a deviated septum, making it hard to check for nasal polyps.I have cystic fibrosis.I have not had a sinus or upper respiratory infection in the last 2 weeks.I have a fungal infection in my sinuses.I have antrochoanal polyps.I have ongoing nasal congestion caused by overusing nasal sprays.I am not allergic to any components of depemokimab.I do not have COVID-19, haven't been in contact with anyone who has it, and don't have lingering taste or smell issues from it.
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving depemokimab (GSK3511294)
- Group 2: Participants receiving Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Nasal Polyps Patient Testimony for trial: Trial Name: NCT05281523 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies in this experiment for new participants?
"The study is presently looking for patients, as indicated by the clinicaltrials.gov website. This information was originally posted on April 18th, 2022 and last edited on November 4th, 2022."
Answered by AI
Does this drug testing happen in more than one location?
"To avoid extensive travelling, patients should try and enroll at the clinical trial site closest to them. There are presently 10 sites recruiting for this study, which are located in Morgantown, Roseville, Lake Mary and 10 other locations."
Answered by AI
What are the desired outcomes of this clinical trial?
"According to the clinical trial's sponsor, GlaxoSmithKline, the primary outcome being measured is change from baseline in mean nasal obstruction score. This will be done over a 52 week period using a 4 point scale ranging from no symptoms to severe symptoms. Additionally, this study will also assess secondary outcomes including change from baseline in asthma control questionnaire score and sino-nasal outcome test score."
Answered by AI
How many individuals are enrolled in this research project?
"The information available on clinicaltrials.gov does indicate that this study is still recruiting patients. According to the site, the trial was originally posted on April 18th, 2022 and was last updated on November 4th of the same year. The study intends to recruit a total of 250 patients from 10 different locations."
Answered by AI
What is the FDA's opinion of Depemokimab (GSK3511294)?
"There is supporting clinical data for Depemokimab's (GSK3511294) efficacy and safety, so it received a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m coughing. Stuffy nose.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- GSK Investigational Site: < 24 hours
Average response time
- < 1 Day
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