1100 Participants NeededMy employer runs this trial

Tilrekimig for Asthma

Recruiting at 11 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Must be taking: ICS, LABA
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 aims to determine if a new treatment, tilrekimig, is safe and effective for individuals with severe asthma, a condition that impairs breathing and can significantly impact daily life. Participants will receive either tilrekimig or a placebo (a substance with no active medicine) every four weeks. Researchers will compare the results to assess whether tilrekimig improves asthma symptoms. This trial is open to individuals who have had severe asthma for at least a year and have experienced at least two asthma attacks in the past year. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking asthma treatment.

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

Studies have shown that tilrekimig is generally well-tolerated in humans. Earlier research on atopic dermatitis, a skin condition, revealed no significant safety concerns for patients taking tilrekimig. Reports indicated that side effects were similar to those experienced by people taking a placebo, which contains no active drug. No serious safety issues related to the dosage were observed.

Further studies on tilrekimig have also found a good safety record with no major side effects. Participants did not experience severe or unexpected reactions. These findings suggest that tilrekimig might be a safe option for treating conditions like asthma, as it is currently being tested for this purpose.12345

Why do researchers think this study treatment might be promising for asthma?

Tilrekimig is unique because it targets specific pathways in the immune system involved in asthma, potentially offering a new approach to managing the condition. Unlike standard treatments such as inhaled corticosteroids or bronchodilators, which primarily focus on reducing inflammation and opening airways, tilrekimig works by modulating immune responses, potentially reducing asthma symptoms more effectively. Researchers are excited about its potential to provide better control of asthma symptoms with possibly fewer side effects than current options.

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

Research has shown that tilrekimig, which participants in this trial may receive, may help treat severe asthma. In earlier studies, patients tolerated the treatment well, experiencing few serious side effects. Although researchers primarily studied tilrekimig for atopic dermatitis, its mechanism has also proven successful for severe asthma. This gives researchers hope that it could help reduce asthma symptoms. The treatment's strong safety record and mechanism suggest it could be an effective option for managing 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, ongoing asthma for at least the past year.
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
I have used medium-to-high dose inhaled steroids and another controller for at least 12 months.
See 1 more

Exclusion Criteria

I have received or plan to receive immunoglobulin within 12 weeks before screening.
I have had a lung disease other than asthma in the past year.
I have had bronchial thermoplasty in the last 2 years.
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 tilrekimig or placebo approximately every 4 weeks

52 weeks
13 visits (in-person)

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 about every four weeks, compared to a placebo (a shot with no active medicine) to see if it helps people with 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 phase 2 study of trispecific antibody positive in ...

Tilrekimig was well-tolerated with a favourable safety profile and no dose dependent safety signals; adverse event (AE) rates were comparable to ...

Pfizer Trispecific Hits EASI-75 at Every Dose in Eczema

TSLP blockade has since succeeded in severe asthma and has never produced a positive controlled result in atopic dermatitis, which puts the ...

Pfizer's Antibody Shows Promise in Atopic Dermatitis Study

49.4% for the high tested dose. The two highest dose levels tested with tilrekimig strongly suggest potentially meaningful improvements to ...

(PDF) Real-World Effectiveness of Dupilumab in Severe ...

After 21 ± 8 months, ACT improved from 15.7 to 23.3, Annual exacerbations decreased from 7.9 to 0.7, ED visits from 3.17 to 0.28, use from 11.8 ...

tilrekimig and rHuPH20 Phase 3 for Asthma

The program includes four Phase 3 studies across severe asthma, moderate to severe atopic dermatitis, and moderate to severe chronic obstructive ...

Pfizer's trispecific tilrekimig clears EASI-75 across all doses ...

In Stage 1, 62.5% of patients on 450 mg every two weeks achieved EASI-75 versus 19.9% on placebo, with monthly doses yielding 47.8% to 61.0%.

Tilrekimig Drug Profile

Product Description. Pfizer is developing PF-07275315, an anti-IL-4/ IL-13/ TSLP biologic for the development of Atopic Dermatitis.

Pfizer's Tilrekimig Shows Promise in Atopic Dermatitis Study

Tilrekimig (PF-07275315) was well-tolerated with a favorable safety profile … inflammatory conditions including atopic dermatitis, asthma, and ...

NCT07869043 | A Study to Learn About the ...

The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe ...

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 ...