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Monoclonal Antibodies
Depemokimab for Nasal Polyps (ANCHOR-1 Trial)
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks immediately prior to screening
Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhea (runny nose) based on clinical assessment by the investigator
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and from week 49 to week 52
Awards & highlights
ANCHOR-1 Trial Summary
This trial will study if 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 symptoms for at least 12 weeks, including nasal blockage or discharge, facial pain, or loss of smell. They must have been on daily nasal corticosteroid treatment for 8 weeks prior to screening and may have had previous surgery or steroid treatments for polyps. Exclusions include those unfit for the study due to other health issues, recent cancer survivors, severe septal deviation, acute sinusitis or infections before screening, pregnant women, certain systemic abnormalities uncontrolled by treatment.Check my eligibility
What is being tested?
The trial is testing Depemokimab (GSK3511294), a new medication against a placebo in people with chronic rhinosinusitis with nasal polyps (CRSwNP). The goal is to see if Depemokimab can effectively reduce symptoms compared to not receiving the active drug.See study design
What are the potential side effects?
Possible side effects of Depemokimab are not detailed but could be similar to other monoclonal antibodies which often include allergic reactions at the injection site, headache, fatigue and potential immune system impacts leading to increased risk of infection.
ANCHOR-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been using nasal steroid sprays or washes daily for the last 8 weeks.
Select...
I have severe nasal problems, including congestion, loss of smell, or a runny nose.
Select...
I am 18 years old or older.
ANCHOR-1 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-5 (ACQ-5) score (Scores on a scale)
Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score (Scores on a scale)
Change from Baseline in Sino-Nasal Outcome Test (SNOT)-22 total score (Scores on a scale)
+4 moreANCHOR-1 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
4,750 Previous Clinical Trials
8,067,176 Total Patients Enrolled
7 Trials studying Nasal Polyps
984 Patients Enrolled for Nasal Polyps
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,654 Total Patients Enrolled
5 Trials studying Nasal Polyps
969 Patients Enrolled for Nasal Polyps
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had symptoms like nasal blockage and loss of smell for over 12 weeks.I have an immune system condition not caused by my asthma medication.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.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 not been in a study with mepolizumab, reslizumab, or benralizumab in the last year.My doctor advises against nose surgery for me.I have antrochoanal polyps.I have severe nasal problems, including congestion, loss of smell, or a runny nose.I was hospitalized for asthma within the last month.I have had a parasitic infestation in the last 6 months.I've had nose surgery that changed the structure, affecting nasal polyp score assessments.I have a severe blockage in one nostril due to a deviated septum, making it hard to check for nasal polyps.I have a tumor in my nasal cavity.I have a condition that increases my eosinophil levels, like EGPA or Eosinophilic Esophagitis.My liver function tests are not within the normal range, and I may have serious liver issues.I have been exposed to more than 10 mSv of radiation due to work or research in the last 3 years.The doctor has checked your nose and found a score of at least 5 out of 8, with at least 2 points in each side of the nose.I do not have a current diagnosis of vasculitis.I am 18 years old or older.I have had symptoms like nasal blockage and loss of smell for over 12 weeks.I am a man or a woman eligible for this trial.I have been using nasal steroid sprays or washes daily for the last 8 weeks.I have had nasal surgery, used steroids for nasal polyps, or can't tolerate steroids.If the doctor thinks you might have COVID-19, or if you have been near someone with COVID-19 in the last 14 days, you cannot join the study. If you have lost your sense of smell or taste because of COVID-19, you cannot join the study.My cancer has been in remission for less than a year.I am currently experiencing a persistent stuffy nose due to long-term nasal spray use.I have a serious health condition that isn't managed well with treatment.I have not had any nose or sinus surgery in the last 6 months, except for a nasal biopsy.I have cystic fibrosis.I am not allergic to any components of depemokimab.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current level of approval for Depemokimab (GSK3511294)?
"Depemokimab (GSK3511294) has received a safety score of 3. This is partially because it is a Phase 3 trial, meaning that there is not just data supporting efficacy, but multiple rounds of data affirming its safety."
Answered by AI
At how many facilities are patients being recruited for this clinical trial?
"17 trial sites are currently operational. They are situated in Meridian, Tampa, New Brunswick and other locations. To cut down on travel for participants, it is best to select the closest site."
Answered by AI
What goals does this trial hope to achieve?
"The purpose of this study is to see if the medication has an effect on reducing the size of nasal polyps. This will be measured by looking at the change in total endoscopic Nasal polyps (NP) score from Baseline to Week 52. Additionally, we will also look at secondary outcomes including the change in mean nasal obstruction score using VRS from Weeks 21 to 24 and the change in mean symptom score for loss of smell using VRS. The study will also assess participants' Asthma Control Questionnaire-5 (ACQ-5) scores to determine impact on asthma control."
Answered by AI
Is this experiment recruiting new test subjects?
"This information can be found on clinicaltrials.gov. The trial was first advertised on 4/22/2022 and has since been edited (11/4/2022)."
Answered by AI
How many people fit the criteria to participate in this clinical trial?
"That is correct. The clinical trial mentioned is recruiting patients, as stated on the website. This particular study was posted on 4/22/2022 and updated last on 11/4/2022; at the moment, there are 17 sites looking for a total of 250 individuals to participate."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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