PF-07275315 for Asthma

Recruiting at 6 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

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected. This study is seeking participants who: * Are 18 to 70 years old * Have had moderate-to-severe asthma for at least 12 months that is not well controlled * Have been taking their regular maintenance treatment(s) for asthma over the last 12 months All participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. PF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. 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 effective. Participants will be involved in this study for about 9.5 months. During this time, they will have 10 visits at the study clinic.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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