Atopic DermatitisPhase 3TilrekNCT07783425
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
A Phase 3 study testing Tilrekimig and Dupilumab in people with Atopic Dermatitis, run by Pfizer at 32 sites in 2 countries.
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 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. 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 and Dupilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,375 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 24 Aug 2026to 15 Jun 2029
- 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
- You are [12] years of age or older
- You have had moderate-to-severe eczema for at least 1 year
- Topical medicines for eczema have not worked well for you
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
32 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 2 countries
United States20 sites, 20 recruiting
- Not yet recruiting
Alexandria Associates in Dermatology
Arlington, Virginia, 22206
- Not yet recruiting
Treasure Valley Medical Research
Boise, Idaho, 83706
- Recruiting
Dermatology Trial Associates, Inc.
Bryant, Arkansas, 72022
- Not yet recruiting
Best Skin Research, LLC
Camp Hill, Pennsylvania, 17011
- Recruiting
Dermatology Treatment and Research Center
Dallas, Texas, 75230
- Recruiting
Derm Texas
Dallas, Texas, 75235
- Not yet recruiting
Maryland Laser Skin and Vein
Hunt Valley, Maryland, 21030
- Recruiting
Marvel Clinical Research
Huntington Beach, California, 92647
- Recruiting
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250
- Not yet recruiting
California Allergy & Asthma Medical Group
Los Angeles, California, 90025
- Recruiting
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, 30060
- Recruiting
Clinical Neuroscience Solutions, LLC.
Memphis, Tennessee, 38119
- Recruiting
Northridge Clinical Trials, LLC
Northridge, California, 91325
- Recruiting
Clinical Neuroscience Solutions, LLC
Orlando, Florida, 32801
- Not yet recruiting
Alliance Dermatology & MOHS Center
Phoenix, Arizona, 85032
- Not yet recruiting
Stryde Research-Epiphany Dermatology
Southlake, Texas, 76092
- Recruiting
Complete Dermatology
Sugar Land, Texas, 77479
- Not yet recruiting
Revival Research Institute, LLC
Troy, Michigan, 48084
- Recruiting
Vital Prospects Clinical Research Institute., PC
Tulsa, Oklahoma, 74136
- Recruiting
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
Japan12 sites, 12 recruiting
- Not yet recruiting
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, 103-0025
- Not yet recruiting
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031
- Not yet recruiting
Osaka Habikino Medical Center
Habikino, Osaka, 583-8588
- Not yet recruiting
Katahira Dermatology Urology Clinic
Kagoshima, 890-0063
- Not yet recruiting
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Aichi-ken, 457-8510
- Not yet recruiting
Okayama University Hospital
Okayama, 700-8558
- Not yet recruiting
Pansy Skin Clinic
Saitama, 330-0064
- Not yet recruiting
Izumigaoka Skin Clinic
Sakai, Osaka, 590-0111
- Not yet recruiting
Dermatology and Ophthalmology Kume Clinic
Sakai, Osaka, 593-8324
- Not yet recruiting
Tachikawa Dermatology Clinic
Tachikawa, Tokyo, 190-0023
- Not yet recruiting
Ikebukuro-nishiguchi Fukurou Dermatology Clinic
Toshima-ku, Tokyo, 171-0021
- Not yet recruiting
Queen's Square Medical Facilities Queen's Square Medical Center, Dermatology and Allergology
Yokohama, Kanagawa, 220-6208
About this study
Official title: A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, ACTIVE- AND PLACEBO-CONTROLLED PHASE 3 MONOTHERAPY STUDY WITH MAINTENANCE PERIOD TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND 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 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:
Read more
- 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Tilrekimig, Dupilumab, Placebo for Tilrekimig, Placebo for Dupilumab
- Keywords
- Immune system diseases, skin diseases, genetic, eczema, atopic dermatitis, Dermatitis, skin diseases, Skin Diseases, Eczematous
- Medical subject headings
- Dermatitis, Atopic, Immune System Diseases, Skin Diseases, Genetic, Eczema, Dermatitis, Skin Diseases, Skin Diseases, Eczematous
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
DupilumabDrug
Also called Dupixent
Subcutaneous Injections at required timepoints based on weight and age.
Placebo for TilrekimigOther
Also called Placebo for PF-07275315
Subcutaneous Injections at required timepoints
Placebo for DupilumabOther
Subcutaneous Injections at required timepoints during initial treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Tilrekimig - Initial treatment period | Experimental | Subcutaneous injections given over 20 Weeks. Receives: Drug: Tilrekimig |
| Placebo - Initial treatment period | Placebo comparator | Subcutaneous injections given over 22 Weeks. Receives: Other: Placebo for Tilrekimig; Other: Placebo for Dupilumab |
| Tilrekimig - Maintenance Period - Dose B | Experimental | Subcutaneous injections given at Week 24 through Week 48. Receives: Drug: Tilrekimig |
| Tilrekimig - Maintenance Period - Dose A | Experimental | Subcutaneous injections given at Week 24 through Week 48. Receives: Drug: Tilrekimig |
| Dupilumab - Initial treatment period | Active comparator | Subcutaneous injections given over 22 Weeks. Receives: Drug: Dupilumab |
| Placebo - Maintenance Period | Placebo comparator | Subcutaneous injections given at Week 24 through Week 48. Receives: Other: Placebo for Tilrekimig; Other: Placebo for Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Measured: Week 16
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Measured: Week 16
Secondary outcomes (44)
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo
Measured: Week 1 through Week 24
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab
Measured: Week 1 through Week 24
Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), 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.
Incidence of clinically significant changes in vital signs and laboratory tests.
Measured: For each participant following first administration of the study intervention through the end of study visit (week 64).
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo.
Measured: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab.
Measured: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab
Measured: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in POEM between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.
Measured: Weeks 8, 16, and 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo.
Measured: Week 1 through week 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab.
Measured: Week 1 through Week 24
Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo.
Measured: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo
Measured: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Proportion of maintaining response at Week 52 (defined as meeting ≥50% improvement from baseline in EASI and vIGA-AD <3) for participants who responded to tilrekimig (defined as achieving either EASI75 or vIGA-ADTM 0/1 at Week 24).
Measured: Week 52
The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo.
Measured: Weeks 28, 36, 44, 52, and 64
Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo.
Measured: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start24 Aug 2026
- Primary completion8 Sep 2028 (estimated)
- Study completion15 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783425
- Sponsor's protocol ID
- C4531005
- Other IDs
- 2026-525743-32-00
- Acronym
- Tilrek
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 22 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, ACTIVE- AND PLACEBO-CONTROLLED PHASE 3 MONOTHERAPY STUDY WITH MAINTENANCE PERIOD TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS
- ClinicalTrials.gov ID
- NCT07783425
- Acronym / sponsor ID
- Tilrek / C4531005
- Conditions
- Atopic Dermatitis
- Keywords
- Immune system diseases, skin diseases, genetic, eczema, atopic dermatitis, Dermatitis, skin diseases, Skin Diseases, Eczematous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,375 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 24 Aug 2026 (actual)
- Primary completion
- 8 Sep 2028 (estimated)
- Study completion
- 15 Jun 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tilrekimig - Initial treatment period | Experimental | Drug: TilrekimigSubcutaneous injections given over 20 Weeks. |
| Placebo - Initial treatment period | Placebo comparator | Other: Placebo for Tilrekimig, Other: Placebo for DupilumabSubcutaneous injections given over 22 Weeks. |
| Tilrekimig - Maintenance Period - Dose B | Experimental | Drug: TilrekimigSubcutaneous injections given at Week 24 through Week 48. |
| Tilrekimig - Maintenance Period - Dose A | Experimental | Drug: TilrekimigSubcutaneous injections given at Week 24 through Week 48. |
| Dupilumab - Initial treatment period | Active comparator | Drug: DupilumabSubcutaneous injections given over 22 Weeks. |
| Placebo - Maintenance Period | Placebo comparator | Other: Placebo for Tilrekimig, Other: Placebo for DupilumabSubcutaneous injections given at Week 24 through Week 48. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- You are [12] years of age or older
- You have had moderate-to-severe eczema for at least 1 year
- Topical medicines for eczema have not worked well for you
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TilrekimigAlso: PF-07275315Subcutaneous Injections at required timepoints | Drug | Tilrekimig - Initial treatment period, Tilrekimig - Maintenance Period - Dose A, Tilrekimig - Maintenance Period - Dose B |
| DupilumabAlso: DupixentSubcutaneous Injections at required timepoints based on weight and age. | Drug | Dupilumab - Initial treatment period |
| Placebo for TilrekimigAlso: Placebo for PF-07275315Subcutaneous Injections at required timepoints | Other | Placebo - Initial treatment period, Placebo - Maintenance Period |
| Placebo for DupilumabSubcutaneous Injections at required timepoints during initial treatment period. | Other | Placebo - Initial treatment period, Placebo - Maintenance Period |
Primary outcome
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Time frame: Week 16
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Time frame: Week 16
44 secondary outcomes
Difference in the proportion of Peak Pruritis Numerical Rating Score (PP-NRS)4 responders between tilrekimig versus placebo
Time frame: Week 1 through Week 24
Difference in the proportion of PP-NRS4 responders between tilrekimig versus dupilumab
Time frame: Week 1 through Week 24
Incidence of treatment emergent adverse events (AEs), Serious adverse events (SAEs), and AEs leading to discontinuation
Time frame: 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.
Incidence of clinically significant changes in vital signs and laboratory tests.
Time frame: For each participant following first administration of the study intervention through the end of study visit (week 64).
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 14, 20, and 24
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of revised Global Investigator Assessment (rIGA) 0/1 responders between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20, and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the proportion of EASI50, EASI90, and EASI100 responders between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 14, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus placebo.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the mean percent CFB in Body Surface Area (BSA) between tilrekimig versus dupilumab.
Time frame: Weeks 2, 4, 8, 12, 16, 20 and 24
Difference in the proportion of Patient Oriented Eczema Measure (POEM) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of POEM responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders achieving ≥4-point improvement from baseline between tilrekimig versus dupilumab
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Severity (PGI-S) responders achieving a score of 0 or 1 between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Patient Global Impression of Change (PGI-C) responders achieving "Much better" between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the proportion of Atopic Dermatitis Control Tool (ADCT) responders achieving ≥5-point improvement from baseline between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in POEM between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in EASI total score between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in DLQI between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in Children's Dermatology Life Quality Index (CDLQI) between tilrekimig versus placebo.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in CDLQI between tilrekimig versus dupilumab.
Time frame: Weeks 8, 16, and 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus placebo.
Time frame: Week 1 through week 24
Difference in the mean percent CFB in PP-NRS weekly average between tilrekimig versus dupilumab.
Time frame: Week 1 through Week 24
Proportion of responders for EASI75, rIGA 0/1, vIGA-AD 0, PP-NRS4, EASI50, EASI90, and EASI100 for tilrekimig doses and placebo.
Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Mean of percent CFB in EASI and BSA for tilrekimig doses and placebo
Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Proportion of maintaining response at Week 52 (defined as meeting ≥50% improvement from baseline in EASI and vIGA-AD <3) for participants who responded to tilrekimig (defined as achieving either EASI75 or vIGA-ADTM 0/1 at Week 24).
Time frame: Week 52
The proportion of POEM responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
The proportion of DLQI responders achieving ≥4-point improvement from baseline for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
The proportion of PGI-S responders achieving a score of 0 or 1 for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tilrekimig and Dupilumab in people with Atopic Dermatitis, run by Pfizer at 32 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 3 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 22 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 32 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 Area 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?
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 22 Oct 2026.