Tilrekimig for Eczema

(Tilrek Trial)

Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
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?

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 severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin.

The study is seeking participants who:

* Are aged 12 years or older.

* Were confirmed to have atopic dermatitis (AD) at least 12 months ago.

* Are not having an effective treatment result from medicines that are applied on skin for AD.

* Are considered by their doctors to have moderate to severe AD.

The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48.

Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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

What Are the Treatments Tested in This Trial?

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