1375 Participants NeededMy employer runs this trial

Tilrekimig for Eczema

(Tilrek Trial)

Recruiting at 49 trial locations
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
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new treatment, tilrekimig, for individuals with moderate to severe eczema, a condition causing dryness, itching, and redness. Researchers compare tilrekimig to dupilumab (an existing eczema treatment) and a placebo (a look-alike with no active medicine) to determine which is most effective and safest. Participants must have experienced eczema for at least a year and found creams or ointments ineffective. The study lasts 52 weeks, with an option for some participants to join an extended study to gather more information about long-term effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tilrekimig is generally safe. Studies have found that most people tolerate it well. The most common side effects are mild and include skin infections, tissue issues, and skin reactions at the injection site. Importantly, trials have raised no major safety concerns with the dosage used. This suggests that tilrekimig could be a safe option for treating eczema.12345

Why are researchers excited about this trial's treatments?

Tilrekimig is unique because it introduces a new approach to treating eczema. Unlike the standard treatments like topical corticosteroids or calcineurin inhibitors, Tilrekimig is a biologic that targets specific pathways involved in the inflammatory process of eczema. It involves subcutaneous injections, which could offer a more targeted and potentially longer-lasting relief for patients. Researchers are excited because this could mean fewer side effects and a more effective management of eczema symptoms compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that tilrekimig, one of the treatments in this trial, may help treat eczema by targeting parts of the immune system responsible for skin inflammation. Early results suggest that people using tilrekimig experienced less dryness and itchiness. Some studies have found that similar medicines helped patients achieve clearer skin and fewer flare-ups. Meanwhile, dupilumab, another treatment option in this trial, has already effectively reduced eczema symptoms in many patients by blocking certain proteins that cause inflammation. Both treatments offer hope for those who haven't found relief with other topical medicines.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 aged 12 and older who have had moderate-to-severe eczema (atopic dermatitis) for at least a year, and whose skin treatments haven't worked well. People with immune system problems, serious infections, major autoimmune diseases, significant mental health issues, or serious liver, kidney, or blood problems can't join.

Inclusion Criteria

I am 12 years old or older.
Topical medicines have not improved my eczema.
I have had moderate-to-severe eczema for at least one year.

Exclusion Criteria

I have a weakened immune system or take medicines that suppress my immunity.
I have a history of serious infections or currently have an active infection.
I have a serious autoimmune disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants are randomized to receive tilrekimig, dupilumab, or placebo for 24 weeks

24 weeks
Regular visits for subcutaneous injections

Maintenance Period

Participants continue receiving their assigned treatment for an additional 28 weeks

28 weeks
Regular visits for subcutaneous injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Long-term Extension (optional)

Participants may opt into continuation of treatment long-term in the LTE study C4531008

What Are the Treatments Tested in This Trial?

Interventions

  • Dupilumab
  • Tilrekimig

Trial Overview

The study compares the new medicine tilrekimig to dupilumab (an approved eczema treatment) and placebo in people with moderate-to-severe eczema. Participants are randomly assigned to one of these groups for up to 52 weeks to see how well the medicines work and how safe they are.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Tilrekimig - Maintenance Period - Dose BExperimental Treatment1 Intervention
Group II: Tilrekimig - Maintenance Period - Dose AExperimental Treatment1 Intervention
Group III: Tilrekimig - Initial treatment periodExperimental Treatment1 Intervention
Group IV: Dupilumab - Initial treatment periodActive Control1 Intervention
Group V: Placebo - Initial treatment periodPlacebo Group2 Interventions
Group VI: Placebo - Maintenance PeriodPlacebo Group2 Interventions

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

Eczema: What It Is, Symptoms, Causes, Types & Treatment

Eczema is a common skin condition that causes a skin rash, dry skin and itchiness. There's no cure, but there are treatments to manage your ...

2.

nationaleczema.org

nationaleczema.org/eczema/

What is Eczema?

Eczema is a skin condition that causes dry, itchy skin. Learn about the seven types of eczema, what it looks like and ways to manage it.

Atopic eczema

Find out about atopic eczema, including symptoms, causes and treatments.

Eczema | Dermatitis

Eczema may get better or worse over time, but it is often a long-lasting disease. People who have it may also develop hay fever and asthma. The ...

Psychological Stress and Atopic Dermatitis: A Focus Group ...

Early case studies on the use of insight-oriented psychotherapy in adults with recalcitrant AD resulted in skin clearing and psychiatric improvement.

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 trispecific antibody shows promise in treating eczema

Pfizer claims that, so far, adverse events for tilrekimig are limited but include skin infections, tissue disorders, and skin reactions at the ...

Pfizer's Tilrekimig Shows Promise in Atopic Dermatitis Study

... Tilrekimig (PF-07275315) was well-tolerated with a favorable safety profile Tilrekimig has the potential to be a first-in-class, once ...

E&P Industry Research

Tilrekimig was well-tolerated, with no dose-dependent safety signals ... Atopic dermatitis (eczema). JAMA. 2023 Jan 17;329(3):268. doi: 10.1001/jama ...

Top Atopic Dermatitis Clinical Trials | Power

The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to ...