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Atopic DermatitisPhase 3NCT07765888

A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema

A Phase 3 study testing Tilrekimig in people with Atopic Dermatitis, run by Pfizer at 21 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Tilrekimig
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
21 sitesin 2 countries
Study dates
17 Aug 2026to 2 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Participants 12 years of age or older
  • Must meet the following AD criteria:
  • Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 12 months prior to Day 1
  • An inadequate response to standard of care treatments {eg, at least medium potency topical corticosteroids (TCS)} consistent with AD treatment guidelines
  • Moderate-to-severe eczema for at least 1 year
  • Adolescent participants must be up to date on immunizations per local guidance.

Who cannot join

  • Clinically Significant Autoimmune Disease
  • Significant Infection History or Active Infection
  • Known or Suspected Immunodeficiency/Immunosuppression
  • Significant psychiatric illness or suicidality
  • Clinically significant hepatic, renal, or hematologic abnormalities

Trial locations and contacts

21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

21 sites in 2 countries

United States14 sites, 14 recruiting

  • Kern Research, Inc.

    Bakersfield, California, 93301

    Not yet recruiting

  • Cahaba Dermatology & Skin Health Center

    Birmingham, Alabama, 35244

    Not yet recruiting

  • Derm Texas

    Dallas, Texas, 75235

    Recruiting

  • Red River Research Partners LLC

    Fargo, North Dakota, 58103

    Recruiting

  • Marietta Dermatology Clinical Research, Inc.

    Marietta, Georgia, 30060

    Recruiting

  • Pediatric Skin Research

    Miami, Florida, 33156

    Recruiting

  • Northridge Clinical Trials

    Northridge, California, 91325

    Recruiting

  • AllerVie Clinical Research

    Panama City, Florida, 32405

    Recruiting

  • University Clinical Trials, Inc

    San Diego, California, 92123

    Recruiting

  • Aeroallergy Research Laboratories of Savannah, Inc

    Savannah, Georgia, 31406

    Not yet recruiting

  • ORSO Health

    Scottsdale, Arizona, 85254

    Not yet recruiting

  • Stryde Research-Epiphany Dermatology

    Southlake, Texas, 76092

    Not yet recruiting

  • GCP Research , Global Clinical Professionals

    St. Petersburg, Florida, 33714

    Recruiting

  • Focus Clinical Research

    West Hills, California, 91307

    Not yet recruiting

Other trials in United States

Japan7 sites, 7 recruiting

  • Charme Clinique

    Matsudo, Chiba, 270-2223

    Not yet recruiting

  • Miyata Dermatology Clinic

    Matsudo, Chiba, 271-0092

    Not yet recruiting

  • Aile Home Clinic Nagaoka

    Nagaoka, Niigata, 940-0065

    Not yet recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

    Not yet recruiting

  • Dermatology and Ophthalmology Kume Clinic

    Sakai, Osaka, 593-8324

    Not yet recruiting

  • NTT Medical Center Tokyo

    Shinagawa, Tokyo, 141-8625

    Not yet recruiting

  • Shibaki Dermatology Clinic

    Teine-ku, Hokkaido, 006-0022

    Not yet recruiting

Other trials in Japan

About this study

Official title: A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED PHASE 3 COMBINATION THERAPY STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE OR OLDER WITH MODERATE-TO-SEVERE 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 ointments in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema (also called atopic dermatitis) is a common skin condition that makes the skin dry, itchy, red, and irritated.

  • This 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.
Read more

Participants in this study will randomly receive either tilrekimig or placebo at a 2:1 ratio. A placebo does not have any medicine in it but looks just like the medicine being studied. The study treatment period will be 24 weeks. The last dose of study treatment will be administered at week 20.

Some participants will join the long-term extension study C4531008 at week 24. A long-term extension study is an additional study that participants may be able to join after completing the main study. It allows researchers to continue collecting information about how well the study medicine works and 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 study treatment dose.

Being tested
Tilrekimig, Placebo
Keywords
eczema, atopic dermatitis, Immune system diseases, skin diseases, genetic, Dermatitis, Skin Diseases, Eczematous, skin diseases
Medical subject headings
Dermatitis, Atopic, Eczema, Immune System Diseases, Skin Diseases, Genetic, Dermatitis, Skin Diseases, Eczematous, Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TilrekimigDrug

    Also called PF-07275315

    Subcutaneous Injections at required timepoints

  • PlaceboDrug

    Subcutaneous Injections at required timepoints

Study groups in NCT07765888
Study groupRoleWhat they receive
TilrekimigExperimentalSubcutaneous injections given over 20 weeks
Receives: Drug: Tilrekimig
PlaceboPlacebo comparatorSubcutaneous injections given over 20 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo

    Measured: Week 16

  2. Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo

    Measured: Week 16

Secondary outcomes (24)

  1. Difference in the proportion of revised investigator's global assessment (rIGA) 0/1 responders between tilrekimig versus placebo

    Measured: Week 16

  2. Difference in the proportion of Eczema and Severity Index (EASI)90 responders between tilrekimig versus placebo

    Measured: Week 16

  3. Difference in the proportion of Dermatology Life Quality Index (DLQI) responders between tilrekimig versus placebo

    For participants >= 16 yrs of age

    Measured: Week 16

  4. Difference in the proportion of Peak Pruritus Numerical Rating Scale (PP-NRS)4 responders between tilrekimig versus placebo

    Measured: Weeks 2, 4, 6, 8, and 16

  5. Difference in the mean percent change from baseline (CFB) in EASI total score, between tilrekimig versus placebo

    Measured: Week 16

  6. Incidence of treatment emergent Adverse Events (AE)s, Serious Adverse Events (SAE)s and AEs leading to discontinuation

    Measured: For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention.

  7. Incidence of clinically significant changes in vital signs, and laboratory tests

    Measured: For each participant from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention

  8. Difference in the proportion of EASI75 responders

    Measured: Weeks 2, 4, 8, 12, 20, 24 and 36

  9. Difference in the proportion of vIGA-AD™ 0/1 response

    Measured: Weeks 2, 4, 8, 12, 20, 24 and 36

  10. Difference in the proportion of rIGA 0/1 response

    Measured: Weeks 2, 4, 8, 12, 20, 24 and 36

  11. Difference in the proportion of vIGA-AD™ 0 response defined as achieving a vIGA-AD(™) score of clear (0) (on a 5-point scale)

    Measured: Weeks 2, 4, 8, 12, 16, 20, 24 and 36

  12. Difference in the proportion of PP-NRS4 response at every week except those included as key secondary endpoints

    Measured: Week 1 through Week 24 (except Weeks 2, 4, 6, 8, and 16), plus Week 36

  13. Difference in the proportion of EASI50, EASI90 and EASI100 (≥50%, ≥90% and 100% improvement from baseline in EASI)

    Measured: Time frame for both EASI50 and EASI100 is Weeks 2, 4, 8, 12, 16, 20, 24, and 36. Time frame for EASI90 is Weeks 2, 4, 8, 12, 20, 24, and 36.

  14. Difference in the percent CFB in EASI total score

    Measured: Weeks 2, 4, 8, 12, 20, 24 and 36

  15. Difference in the percent CFB in Body Surface Area (BSA)

    Measured: Weeks 2, 4, 8, 12, 16, 20, 24 and 36

  16. Difference in the proportion of patient Oriented Eczema Measure (POEM) response based on a participant achieving ≥4-point improvement from baseline in POEM

    Measured: Weeks 4, 8, 16, 24 and 36

  17. Difference in the proportion of DLQI response based on a participant achieving ≥4-point improvement from baseline in DLQI at scheduled time points except that included as a key secondary endpoint for participants 16 years or older

    Measured: Weeks 4, 8, 24 and 36

  18. Difference in the proportion of patient global impression of disease severity (PGI-S) response based on a participant achieving a score of None or Mild (0 or 1) in PGI-S

    Measured: Weeks 4, 8, 16, 24 and 36

  19. Difference in the proportion of patient global impression of change in clinical status (PGI-C) response based on a participant achieving "Much Better" in PGI-C

    Measured: Weeks 4, 8, 16, 24 and 36

  20. Difference in the proportion of responders for Atopic Dermatitis Control Tool (ADCT) response based on a participant achieving ≥5-point improvement from baseline in ADCT

    Measured: Weeks 4, 8, 16, 24 and 36

  21. Difference in the mean CFB in POEM

    Measured: Weeks 4, 8, 16, 24 and 36

  22. Difference in the mean CFB in DLQI at scheduled time points for participants 16 years or older

    Measured: Weeks 4, 8, 16, 24 and 36

  23. Difference in the mean CFB in Children's Dermatology Life Quality Index (CDLQI) at scheduled time points for participants 12 to <16 years of age

    Measured: Weeks 4, 8, 16, 24 and 36

  24. Difference in the mean CFB in weekly averages of PP-NRS

    Measured: Week 1 through Week 24, plus Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study start17 Aug 2026
  3. Primary completion10 Mar 2028 (estimated)
  4. Study completion2 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07765888
Sponsor's protocol ID
C4531007
Other IDs
2026-526155-65-00
Status last verified
Oct 2026
First submitted
10 Aug 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tilrekimig in people with Atopic Dermatitis, run by Pfizer at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07765888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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Clinical Trial NCT07765888 | AzTrials