~224 spots leftby Jan 2026

Tozorakimab for COPD

(TITANIA Trial)

Recruiting in Palo Alto (17 mi)
+194 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: AstraZeneca
Must be taking: Inhaled therapy
Disqualifiers: Asthma, Cardiovascular, Infection, Cancer, others
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing injections of a drug called tozorakimab in adults with COPD who have frequent flare-ups. These patients are already on other inhaled treatments but still experience significant symptoms. The drug aims to reduce lung inflammation and prevent these flare-ups.

Will I have to stop taking my current medications?

The trial requires participants to continue their current inhaled COPD medications at stable doses for at least 3 months before joining the study. It doesn't specify if you need to stop other medications, so it's best to discuss with the trial team.

What data supports the effectiveness of the drug Tozorakimab for COPD?

Research on similar treatments, like mepolizumab, shows that targeting specific inflammatory pathways can reduce exacerbation rates in COPD patients with high eosinophil levels. This suggests that Tozorakimab, which may work in a similar way, could potentially be effective for certain COPD patients.12345

What makes the drug Tozorakimab unique for treating COPD?

Tozorakimab (MEDI-3506) is unique for treating COPD because it targets the interleukin-6 (IL-6) pathway, which is involved in inflammation, potentially offering a novel approach compared to standard COPD treatments that primarily focus on bronchodilation and symptom relief.678910

Research Team

Eligibility Criteria

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.

Inclusion Criteria

Your lung function test shows a specific ratio and amount of air flow that is not within normal range.
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.
See 6 more

Exclusion Criteria

I have asthma, had it in the past, or have asthma-COPD overlap.
I have active tuberculosis.
Any clinically significant abnormal findings in physical examination, vital signs, ECG, or laboratory testing during the screening period, which in the opinion of the investigator may put the participant at risk because of their participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
See 15 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous doses of tozorakimab or placebo for COPD management

52 weeks
Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • MEDI3506 (Monoclonal Antibodies)
  • Tozorakimab (Monoclonal Antibodies)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Research Locations NearbySelect from list below to view details:
Research SiteLivonia, MI
Research SiteSalt Lake City, UT
Research SiteAndalusia, AL
Research SiteOklahoma City, OK
More Trial Locations
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Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4491
Patients Recruited
290,540,000+

Findings from Research

In a meta-analysis of 1136 patients from the METREX and METREO trials, mepolizumab significantly reduced the annual rate of moderate to severe exacerbations in COPD patients with elevated blood eosinophil counts by 18% compared to placebo.
The study found that higher blood eosinophil counts were associated with greater efficacy of mepolizumab, suggesting that patients with eosinophil counts of ≥150 cells/µL at screening or ≥300 cells/µL in the prior year are more likely to benefit from this treatment.
Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO.Pavord, ID., Chapman, KR., Bafadhel, M., et al.[2021]
Monoclonal antibody (mAB) therapies have a moderate effect on reducing the risk of exacerbations in chronic obstructive pulmonary disease (COPD), but they do not significantly improve lung function (FEV1) or quality of life (SGRQ).
In eosinophilic COPD patients, the IL-5 antagonist mepolizumab was found to reduce exacerbation risk, while benralizumab showed effectiveness in improving both lung function and quality of life, highlighting the potential of targeting IL-5 pathways in specific patient populations.
Emerging biological therapies for treating chronic obstructive pulmonary disease: A pairwise and network meta-analysis.Rogliani, P., Matera, MG., Puxeddu, E., et al.[2019]
Mepolizumab has been shown to significantly reduce the rate of exacerbations in patients with severe COPD who frequently experience flare-ups and have elevated blood eosinophil levels.
This treatment represents a step forward in precision medicine for COPD, allowing for more targeted therapies based on individual patient characteristics.
Precision medicine in COPD: review of mepolizumab for eosinophilic COPD.Long, G., Wall, J.[2020]

References

Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO. [2021]
Emerging biological therapies for treating chronic obstructive pulmonary disease: A pairwise and network meta-analysis. [2019]
In vitro modeling of COPD inflammation and limitation of p38 inhibitor - SB203580. [2018]
Precision medicine in COPD: review of mepolizumab for eosinophilic COPD. [2020]
Current Perspectives on Biological Therapy for COPD. [2023]
Initiating tocilizumab, with or without methotrexate, compared with starting methotrexate with prednisone within step-up treatment strategies in early rheumatoid arthritis: an indirect comparison of effectiveness and safety of the U-Act-Early and CAMERA-II treat-to-target trials. [2020]
A Review of Recent Advances Using Tocilizumab in the Treatment of Rheumatic Diseases. [2023]
Anti-proliferative action of IL-6R-targeted antibody tocilizumab for non-small cell lung cancer cells. [2020]
Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. [2022]
Subcutaneous tocilizumab alone or with a csDMARD in rheumatoid arthritis patients: subanalysis of Italian data from a multicenter phase IIIb/IV trial. [2020]