1100 Participants NeededMy employer runs this trial

Tilrekimig for Severe Asthma

Recruiting at 15 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new medicine, tilrekimig, can safely and effectively aid people with severe asthma, a condition that makes breathing difficult. Participants will receive either tilrekimig or a placebo (a harmless, inactive substance) to compare their effects. The trial seeks individuals who have had severe asthma for at least a year and have experienced at least two asthma attacks requiring treatment in the past year. Those with persistent, severe asthma who meet these criteria might find this study a good fit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Is there any evidence suggesting that tilrekimig is likely to be safe for humans?

Research has shown that the treatment tilrekimig is generally safe for patients. In earlier studies, higher doses did not cause additional safety issues. The side effects resembled those in individuals taking a placebo, a harmless pill used for comparison. This suggests that tilrekimig is likely safe to use.12345

Why do researchers think this study treatment might be promising?

Most treatments for severe asthma, like inhaled corticosteroids and bronchodilators, work by reducing inflammation or opening airways. But tilrekimig works differently, targeting specific immune pathways that contribute to asthma attacks. This unique mechanism could provide more effective control over asthma symptoms and reduce the frequency of severe attacks. Researchers are excited because tilrekimig offers a potential new option for patients who don't respond well to current therapies, promising improved quality of life and better overall management of severe asthma.

What evidence suggests that tilrekimig might be an effective treatment for severe asthma?

Research has shown that tilrekimig, which participants in this trial may receive, may help improve asthma symptoms. In one study, patients experienced quick improvements in asthma control and lung function, with 71% not having severe asthma attacks. Similar treatments have also led to fewer asthma flare-ups and a better quality of life. While tilrekimig has also helped with skin conditions like eczema, its ability to reduce asthma attacks is particularly promising for people with severe asthma.678910

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for people who have had severe asthma for at least a year and have experienced at least two asthma attacks in the past year.

Inclusion Criteria

I have had severe asthma for at least the past year.
I have used medium-to-high dose inhaled steroids and another controller for at least 12 months.
Positive bronchodilator responsiveness of FEV1 or FVC >10% of predicted value at 15-30 minutes after inhaling 400 µg salbutamol/albuterol or equivalent SABA during screening spirometry
See 1 more

Exclusion Criteria

Any psychiatric condition including active suicidal ideation in past year or suicidal behavior in past 5 years increasing risk or deemed inappropriate by investigator
I have had a lung disease other than asthma in the past year.
I have taken corticosteroid medications in the past 28 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive shots of study medicine or placebo at the study clinic

52 weeks
Regular visits for administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • tilrekimig

Trial Overview

The study is testing tilrekimig, given as an injection, compared to a placebo (a shot with no active medicine) to see if it helps treat severe asthma. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment Arm A TilrekimigExperimental Treatment1 Intervention
Group II: Treatment Arm B PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Pfizer's tilrekimig delivers Phase II skin clearance ahead of ...

Pfizer's tilrekimig met the Phase II endpoint in atopic dermatitis, improving Week 16 EASI-75 responses across doses versus placebo.

Thymic Stromal Lymphopoietin Inhibitors (TSLP inhibitors) ...

While it showed clear clinical benefit in severe asthma, results in atopic dermatitis have been underwhelming. In trials, tezepelumab did not achieve the ...

Pfizer's Tilrekimig Shows Significant Skin Clearance in ...

In Stage 1, 62.5% of patients receiving tilrekimig 450 mg Q2W achieved EASI-75, compared to 19.9% an absolute improvement of 49.4%, 51.9%, and ...

(PDF) Phenotypic Clusters of Severe Asthma and ...

showed rapid improvements in asthma control, lung function, and quality of life, with 71% and 75% of patients free from exacerbations, ...

Study Shows Positive Results for a Possible New Eczema ...

In the trial, roughly half of patients taking the best-performing dose saw their eczema symptoms improve by 75% or more. This is a meaningful ...

Tilrekimig Drug Profile

Clinical Outcomes Reported - Tilrekimig Clinical Outcomes Reported. Phase 3: Asthma|Chronic Obstructive Pulmonary Disease|Dermatitis, Data Updated NCT07363694

Pfizer's Trispecific Antibody Tilrekimig Shows Positive ...

The therapy demonstrated a favourable safety profile with no dose-dependent safety signals. Overall adverse event rates were comparable to ...

Pfizer's Tilrekimig shows significant skin clearance in ...

Safety: • Tilrekimig was well-tolerated, with no dose-dependent safety signals, with treatment-emergent adverse event (TEAE) rates ...

View PDF

The study met its primary endpoint, demonstrating a statistically significant increase in the percentage of participants achieving EASI-75* (? ...

Clinical Trial for Atopic Dermatitis.

The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to ...