Tilrekimig for Asthma
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive shots of tilrekimig or placebo approximately every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Tilrekimig
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
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 ...
6.
trial.medpath.com
trial.medpath.com/news/pfizer-s-trispecific-tilrekimig-clears-easi-75-across-all-doses-in-phase-ii-atopic-dermatitis-trialPfizer'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 ...
10.
clival.com
clival.com/news/pfizers-tilrekimig-shows-significant-skin-clearance-in-phase-2-atopic-dermatitis-studyPfizer'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 ...
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