A Phase 3 interventional study of Tilrekimig and Placebo in Atopic Dermatitis, sponsored by Pfizer. Recruiting at 21 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
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 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.
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.
1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.
This study's planned enrollment of 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must meet the following AD criteria:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 20 weeks
Drug: Placebo
Subcutaneous Injections at required timepoints
Also known as: PF-07275315
Subcutaneous Injections at required timepoints
Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of revised investigator's global assessment (rIGA) 0/1 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Eczema and Severity Index (EASI)90 responders between tilrekimig versus placebo
Time frame: Week 16
Difference in the proportion of Dermatology Life Quality Index (DLQI) responders between tilrekimig versus placebo
For participants \>= 16 yrs of age
Time frame: Week 16
Difference in the proportion of Peak Pruritus Numerical Rating Scale (PP-NRS)4 responders between tilrekimig versus placebo
Time frame: Weeks 2, 4, 6, 8, and 16
Difference in the mean percent change from baseline (CFB) in EASI total score, between tilrekimig versus placebo
Time frame: Week 16
Incidence of treatment emergent Adverse Events (AE)s, Serious Adverse Events (SAE)s 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 from the time the participant provides informed consent, through and including a minimum of 16 weeks after the last administration of the study intervention
Difference in the proportion of EASI75 responders
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of vIGA-AD™ 0/1 response
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of rIGA 0/1 response
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the proportion of vIGA-AD™ 0 response defined as achieving a vIGA-AD(™) score of clear (0) (on a 5-point scale)
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36
Difference in the proportion of PP-NRS4 response at every week except those included as key secondary endpoints
Time frame: Week 1 through Week 24 (except Weeks 2, 4, 6, 8, and 16), plus Week 36
Difference in the proportion of EASI50, EASI90 and EASI100 (≥50%, ≥90% and 100% improvement from baseline in EASI)
Time frame: 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.
Difference in the percent CFB in EASI total score
Time frame: Weeks 2, 4, 8, 12, 20, 24 and 36
Difference in the percent CFB in Body Surface Area (BSA)
Time frame: Weeks 2, 4, 8, 12, 16, 20, 24 and 36
Difference in the proportion of patient Oriented Eczema Measure (POEM) response based on a participant achieving ≥4-point improvement from baseline in POEM
Time frame: Weeks 4, 8, 16, 24 and 36
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
Time frame: Weeks 4, 8, 24 and 36
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
Time frame: Weeks 4, 8, 16, 24 and 36
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
Time frame: Weeks 4, 8, 16, 24 and 36
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
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in POEM
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in DLQI at scheduled time points for participants 16 years or older
Time frame: Weeks 4, 8, 16, 24 and 36
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
Time frame: Weeks 4, 8, 16, 24 and 36
Difference in the mean CFB in weekly averages of PP-NRS
Time frame: Week 1 through Week 24, plus Week 36
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
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