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Monoclonal Antibodies
Tozorakimab for COPD (TITANIA Trial)
Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment
Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52, or over 52 weeks
Awards & highlights
TITANIA Trial Summary
This trial is testing a new COPD medication to see if it is effective and safe.
Who is the study for?
Adults over 40 with COPD, a smoking history of at least 10 pack-years, and who've had multiple flare-ups in the past year can join. They must have been on stable inhaled therapy for 3 months and give consent. Excluded are those with other significant lung diseases, recent drug use or infections, unstable health conditions, certain cancer histories, or previous tozorakimab treatment.Check my eligibility
What is being tested?
The trial is testing two doses of Tozorakimab against a placebo in people with COPD to see if it's safe and effective. Participants will receive injections under the skin while continuing their usual inhaler medications.See study design
What are the potential side effects?
While specific side effects for Tozorakimab aren't listed here, common ones for similar treatments include injection site reactions, increased risk of infections due to immune system changes, fatigue, headaches and potential allergic reactions.
TITANIA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Select...
I am 40 years or older and can sign a consent form.
TITANIA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 52, or over 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52, or over 52 weeks
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 to severe COPD exacerbations in participants who are former smokers.
Secondary outcome measures
Annualized rate of healthcare resource utilization in former smokers.
Annualized rate of moderate to severe COPD exacerbations in former or current smokers.
Annualized rate of severe COPD exacerbations in former smokers.
+18 moreTITANIA Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Tozorakimab Dose 2Experimental Treatment1 Intervention
Dosing subcutaneously tozorakimab Dose 2
Group II: Tozorakimab Dose 1Experimental Treatment1 Intervention
Dosing subcutaneously tozorakimab Dose 1 and placebo
Group III: PlaceboPlacebo Group1 Intervention
Dosing subcutaneously with equivalent volume to tozorakimab
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,611,540 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have asthma, had it in the past, or have asthma-COPD overlap.I have active tuberculosis.I have a significant lung condition that is not COPD.My scans show a lung problem not caused by COPD that's affecting my breathing.Your lung function test shows a specific ratio and amount of air flow that is not within normal range.I have been diagnosed with heart or lung blood pressure issues.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer treated successfully over a year ago.I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.I have had hepatitis B or C, but hepatitis C has been cured.I haven't had a serious infection or pneumonia in the weeks before joining the study.I had a severe COPD flare-up requiring steroids, antibiotics, or hospital stay within the last 2 weeks.I do not have active liver disease or jaundice.I have been diagnosed with COPD for at least a year.I am 40 years or older and can sign a consent form.I have had a serious COVID-19 infection in the last 6 months.I am suspected of or confirmed to have COVID-19.You have used e-cigarettes or smoked marijuana in the past 6 months before joining the study or during the study.I have previously been treated with tozorakimab.I do not have any unstable health conditions that could affect my safety or participation in the study.You have smoked a pack a day for at least 10 years.I have a stable heart condition.You have smoked an average of one pack per day for at least 10 years.I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.You have a cough and phlegm, and your combined score for these symptoms is 10 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Tozorakimab Dose 1
- Group 2: Placebo
- Group 3: Tozorakimab Dose 2
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 Tozorakimab's regulatory status?
"There is clinical evidence backing the safety of Tozorakimab, as this drug has completed Phase 3 trials."
Answered by AI
How many different medical clinics are currently conducting this medical study?
"Currently, there are 35 sites accepting enrolment for this study. If you choose to participate in the study, try and select a site close to your location to minimize travel. The locations are based in Colorado Springs, Toledo and White Marsh as well as 35 other locations."
Answered by AI
Does this research only consider young adults, or are older individuals also invited to participate?
"In order to participate in this clinical trial, patients must meet the age requirement of being between 40 to 130 years old. Out of the 515 total clinical trials, this is one of the 36 trials for patients under 18 and one of the 479 trials for patients over 65."
Answered by AI
Who else is applying?
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Just discharged from the Hospital on Oxygen for first time. I am a chemical engineer and worked in a very polluted steel mill for many years developed.
PatientReceived 2+ prior treatments
I ve try a number of trials and enjoyed them all of them. They have been very good on my Copd.
PatientReceived no prior treatments
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