A Phase 3 interventional study of Tilrekimig and Dupilumab in Atopic Dermatitis, sponsored by Pfizer. Recruiting at 50 sites in 4 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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:
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 1,375 is above the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Key Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subcutaneous injections given over 20 Weeks.
Drug: Tilrekimig
Subcutaneous injections given over 22 Weeks.
Other: Placebo for Tilrekimig · Other: Placebo for Dupilumab
Subcutaneous injections given at Week 24 through Week 48.
Drug: Tilrekimig
Subcutaneous injections given at Week 24 through Week 48.
Drug: Tilrekimig
Subcutaneous injections given over 22 Weeks.
Drug: Dupilumab
Subcutaneous injections given at Week 24 through Week 48.
Other: Placebo for Tilrekimig · Other: Placebo for Dupilumab
Subcutaneous Injections at required timepoints
Also known as: PF-07275315
Subcutaneous Injections at required timepoints based on weight and age.
Also known as: Dupixent
Subcutaneous Injections at required timepoints
Also known as: Placebo for PF-07275315
Subcutaneous Injections at required timepoints during initial treatment period.
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
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
The proportion of PGI-C responders achieving "Much better" for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
The proportion of ADCT responders achieving ≥5-point improvement from baseline for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
Mean of CFB in POEM, DLQI, and CDLQI for tilrekimig doses and placebo.
Time frame: Weeks 28, 36, 44, 52, and 64
Mean of CFB in weekly averages of PP=NRS for tilrekimig doses and placebo.
Time frame: Weeks 26, 28, 32, 36, 40, 44, 48, 52, and 64
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
Started Aug 2026 (actual). Primary completion is estimated for Sep 2028, 24 months after the start.
Of 149 industry-sponsored phase 3 interventional studies under Dermatitis, Atopic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 28. This study's planned 24 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 13 and three quarters within 28.
Primary completion moved once since we started tracking on Sep 25, 2026: Aug 2028 → Sep 2028, on Oct 6, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Tilrekimig