Tozorakimab for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Obstructive Pulmonary Disease (COPD)Tozorakimab - Drug
Eligibility
40 - 130
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new COPD medication to see if it is effective and safe.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)

Video Summary

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 24 Secondary · Reporting Duration: Week 52, or over 52 weeks

Week 52
Change from baseline in CAT total score.
Percentage of participants with a decrease in CAT total score in former smokers.
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers
Chronic Obstructive Airway Disease
Percentage of responders achieving MCID in E-RS:COPD total score in former smokers.
Percentage of responders achieving MCID in E-RS:COPD total score in the overall population of current and former smokers.
Percentage of responders achieving MCID in SGRQ total score in former smokers.
Percentage of responders achieving MCID in SGRQ total score in the overall population of current and former smokers.
Week 52
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in former smokers.
Mean change from baseline in pre-BD, pre-dose trough FEV1 (mL) in the overall population of current and former smokers.
over 52 weeks
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 moderate to severe COPD exacerbations in participants who are former smokers.
Annualized rate of severe COPD exacerbations in former smokers.
Mean change from baseline in E-RS:COPD total score in former smokers.
Mean change from baseline in E-RS:COPD total score in the overall population of current and former smokers.
Mean change from baseline in SGRQ total score from in former smokers.
Mean change from baseline in SGRQ total score from in the overall population of current and former smokers.
Proportion of participants having ≥ 1 healthcare resource utilization type in former smokers.
The change from baseline in mean number of puffs per day in rescue use in former smokers.
Time to first moderate to severe COPD exacerbation in former smokers.
Time to first severe COPD exacerbation in former smokers.
Trough serum concentrations of MEDI3506.
Trough serum concentrations of tozorakimab.
over 60 weeks
Presence of anti-drug antibodies.

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

7 Treatment Groups

Tozorakimab (MEDI3506) Dose 2
1 of 7
MEDI3506 Dose 1
1 of 7
Tozorakimab Dose 2
1 of 7
MEDI3506 Dose 2
1 of 7
Tozorakimab Dose 1
1 of 7
Tozorakimab (MEDI3506) Dose 1
1 of 7
Placebo
1 of 7

Experimental Treatment

Non-Treatment Group

1272 Total Participants · 7 Treatment Groups

Primary Treatment: Tozorakimab · Has Placebo Group · Phase 3

Tozorakimab (MEDI3506) Dose 2
Drug
Experimental Group · 1 Intervention: Tozorakimab (MEDI3506) Dose 2 · Intervention Types: Drug
MEDI3506 Dose 1
Drug
Experimental Group · 1 Intervention: MEDI3506 · Intervention Types: Drug
Tozorakimab Dose 2
Drug
Experimental Group · 1 Intervention: Tozorakimab · Intervention Types: Drug
MEDI3506 Dose 2
Drug
Experimental Group · 1 Intervention: MEDI3506 · Intervention Types: Drug
Tozorakimab Dose 1
Drug
Experimental Group · 1 Intervention: Tozorakimab · Intervention Types: Drug
Tozorakimab (MEDI3506) Dose 1
Drug
Experimental Group · 1 Intervention: Tozorakimab (MEDI3506) Dose 1 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI3506
2021
Completed Phase 2
~280

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 52, or over 52 weeks

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,994 Previous Clinical Trials
247,421,305 Total Patients Enrolled
189 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
563,179 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Age 40 - 130 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have COPD and you have had two or more exacerbations within the past 12 months.
You have a smoking history of at least 10 pack-years.
You have a post-BD FEV1/FVC < 0.
The total CAT score is ≥10.