PF-07275315 for Asthma

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pfizer

Must be taking: ICS-LABA

Must not be taking: Biologics, JAK inhibitors

Disqualifiers: COPD, Cystic fibrosis, Emphysema, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new medicine, PF-07275315, for treating moderate-to-severe asthma. Asthma can make breathing difficult, affecting daily life and activities. Participants will receive either the new medicine or a placebo (a look-alike with no active ingredients) through several injections over 12 weeks. The trial seeks individuals who have had moderate-to-severe asthma for at least a year and have struggled to control it with their usual treatments.

As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current asthma medications, but it does require that you have been on a stable dose of your regular asthma treatment for at least 3 months before joining. You cannot use certain other medications, like systemic corticosteroids, during the study.

Is there any evidence suggesting that PF-07275315 is likely to be safe for humans?

Research has shown that PF-07275315 has undergone previous testing to assess its safety. In earlier studies, most participants tolerated the treatment well, with no serious side effects reported. Some experienced mild side effects, such as headaches and tiredness, but these were short-lived.

The current study is in an early stage, focusing on ensuring the treatment's safety and effectiveness. While past results are promising, researchers continue to monitor its safety in a larger group. Participants in the trial will have their health carefully monitored to ensure safety. ^{1 2 3 4 5}

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

Researchers are excited about PF-07275315 for asthma because it offers a new approach compared to standard treatments like inhaled corticosteroids and bronchodilators. Unlike these typical therapies, PF-07275315 may work by targeting specific pathways involved in inflammation, potentially leading to better control of asthma symptoms. This could mean fewer side effects and a more tailored treatment for patients, making it a promising candidate for those who don't respond well to current options.

What evidence suggests that PF-07275315 might be an effective treatment for asthma?

Research has shown that PF-07275315 might be a promising new treatment for people with moderate-to-severe asthma. Although it hasn't been approved for asthma yet, early results suggest it could help many who struggle with this condition. The treatment targets specific processes in the body that cause asthma symptoms. Initial studies have demonstrated that similar treatments can improve lung function and better control asthma. If PF-07275315 works similarly, it could be an effective option for those whose asthma isn't well managed by current medications. Participants in this trial will receive PF-07275315 in one of several experimental arms or a placebo in the comparator arm. ^{1 2 6 7 8}

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 aged 18-70 with moderate-to-severe asthma that's been active for at least a year and isn't well-managed despite regular treatment. Participants will be involved in the study for about 9.5 months, with 10 clinic visits.

Inclusion Criteria

ACQ-5 score of ≥1.5 at screening visit and prior to randomization

Body mass index between 18 40 kg/m2 at screening

I meet the specific criteria for asthma.

Exclusion Criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study

History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products

I have not had bronchial thermoplasty in the last 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-07275315 or placebo as multiple shots in the clinic over the course of 12 weeks

12 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PF-07275315

Trial Overview The trial tests PF-07275315, a potential new asthma medication, against a placebo (a shot without any medicine). Over 12 weeks, participants receive multiple shots to determine if PF-07275315 is safe and effective.

How Is the Trial Designed?

Group I: Treatment Arm C Experimental Treatment 1 Intervention

PF-07275315

Group II: Treatment Arm B Experimental Treatment 1 Intervention

PF-07275315

Group III: Treatment Arm A Experimental Treatment 1 Intervention

PF-07275315

Group IV: Treatment Arm D Placebo Group 1 Intervention

Placebo

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

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06977581

NCT06977581 | A Study to Learn About the ... We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and ...

2. trial.medpath.com trial.medpath.com/clinical-trial/7e74f2156656be2b/nct06977581-pf-07275315-efficacy-safety-asthma

A Study to Learn About the Study Medicine Called PF ... We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1081120624015527

Novel asthma treatments: Advancing beyond approved ... Although this drug is not yet approved for use in asthma, these data suggest that it may be an effective treatment strategy in a wide range of patients with ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/420415

A Study To Learn About Two Study Medicines (PF ... The purpose of this study is to learn about the safety and effects of 2 study medicines (PF-07275315 and PF-07264660) for the treatment of atopic dermatitis ...

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-5-2022-ff42f

PF-07275315 in Healthy Subjects · Info for Participants Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume ...

6. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct06977581-asthma-trial

Clinical Trial for Asthma. | Pfizer We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and ...

7. synapse.patsnap.com synapse.patsnap.com/drug/d65b2156fe2845479b4fd9cbcbf0ddfb

PF-07275315 - Drug Targets, Indications, Patents A Phase 1, Randomized, Double-Blind, Third-Party Open, Placebo-Controlled, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability, ...

8. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/35737652/pfizers-new-asthma-treatment-study-key-insights-for-investors/

Pfizer's New Asthma Treatment Study: Key Insights for ... The study aims to evaluate the safety and efficacy of PF-07275315, a potential treatment for moderate-to-severe asthma, a condition that ...