375 Participants NeededMy employer runs this trial

Tilrekimig for Eczema

Recruiting at 20 trial locations
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Must be taking: Topical corticosteroids
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 tests a new treatment called tilrekimig, a potential drug for moderate to severe eczema. The researchers aim to evaluate tilrekimig's effectiveness and safety when combined with medicated creams or ointments. Participants will receive either tilrekimig or a placebo, a look-alike with no active medicine, over a 24-week period. Ideal participants are those aged 12 and up who have had eczema for over a year and haven't found relief with standard skin treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for eczema.

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

Previous studies have shown that patients tolerated tilrekimig well. Research indicates that the side effects resembled those experienced by people who took a placebo, a substance with no active medicine. Higher doses did not cause more problems, demonstrating tilrekimig's good safety record. Although side effects can occur with any treatment, these findings suggest tilrekimig is generally safe for people with eczema.12345

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

Most treatments for eczema, like topical steroids and calcineurin inhibitors, aim to reduce inflammation and suppress the immune response. But Tilrekimig stands out because it's a biologic medication that targets specific pathways in the immune system involved in eczema. This subcutaneous injection has the potential to offer more precise relief with fewer side effects compared to traditional treatments. Researchers are excited about Tilrekimig because it represents a new approach to managing eczema, potentially improving the quality of life for those who struggle with the condition.

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

Research has shown that tilrekimig, which participants in this trial may receive, may help treat atopic dermatitis, also known as eczema. In earlier studies, many participants experienced significant skin improvement with this treatment. Specifically, a large number of patients saw their eczema symptoms reduced by 75%. These improvements surpassed those seen in participants who received a placebo, a treatment with no active medicine. Tilrekimig also helped manage the ongoing inflammation linked to eczema. This suggests that tilrekimig could be a good option for people with moderate to severe eczema.12346

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 aged 12 and older who have had moderate-to-severe eczema (atopic dermatitis) for at least a year, and whose skin hasn't improved enough with standard creams or ointments. Adolescents must be up to date on their vaccines.

Inclusion Criteria

I am 12 years old or older.
I did not improve after using standard treatments, including medium-strength steroid creams.
I am up to date on all required vaccines for my age.
See 2 more

Exclusion Criteria

I have a history of serious infections or currently have an active infection.
I have a serious autoimmune disease.
Significant psychiatric illness or suicidality
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either tilrekimig or placebo for 24 weeks, with the last dose administered at week 20

24 weeks
Subcutaneous injections given over 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term extension

Participants may join a long-term extension study to continue receiving the study medication

What Are the Treatments Tested in This Trial?

Interventions

  • Tilrekimig

Trial Overview

The study compares tilrekimig (an investigational medicine) to a placebo in people with moderate-to-severe eczema. Participants are randomly assigned to receive either tilrekimig or placebo along with usual medicated creams for 24 weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TilrekimigExperimental Treatment1 Intervention
Group II: 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 Shows Significant Skin Clearance in ...

Study met primary endpoint, showing a statistically significant increase in the percentage of participants achieving EASI-75 versus placebo ...

AD Pipeline Watch: Tilrekimig, a Trispecific Antibody, Hits ...

Tilrekimig performed well in adults with moderate-to-severe atopic dermatitis (AD), according to top-line results from a Phase 2 study.

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 when used together with medicated creams or ...

Pfizer Phase II Data Supports Once-Monthly Trispecific ...

In a Phase II trial, Pfizer's tilrekimig demonstrated well-tolerated, dose-dependent improvements in chronic Th2 inflammation, supporting ...

Tilrekimig Phase 2 Data Show EASI 75 Gains in Atopic ...

A significantly greater percentage of patients achieved a 75% reduction in the Eczema Area and Severity Index (EASI 75) at week 16 across all ...

tilrekimig (PF-07275315) / Pfizer

"Tilrekimig was well tolerated, with no dose-dependent safety signals and a similar frequency of adverse events compared with placebo.