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tilrekimig and rHuPH20

Phase 3

Asthma | Small molecule | Respiratory |Pfizer, Inc.|Trials Updated: Oct 22, 2026

tilrekimig and rHuPH20 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Aug 2026

tilrekimig and rHuPH20 target and mechanism

ModalitySmall molecule

Also known as Tilrekimig

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials5
Total Enrollment5,310

FDA Designations

No designations recorded

tilrekimig and rHuPH20 clinical trials

tilrekimig and rHuPH20 · 5 trials · 3 indications

Phase 3 5
NCT07869043A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe AsthmaAsthma
RECRUITING1,100 Analytics
NCT07839884A Continuation Study of Tilrekimig in Adults With Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About This Medicine When Used for a Long Period of TimeModerate to Severe Chronic Obstructive Pulmonary Disease
NOT YET_RECRUITING1,360 Analytics
NCT07783425A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe EczemaAtopic Dermatitis
RECRUITING1,375 Analytics
NCT07772921A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe AsthmaAsthma
RECRUITING1,100 Analytics
NCT07765888A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe EczemaAtopic Dermatitis
RECRUITING375 Analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
AsthmaUnlock trial analytics
PHASE3NOT YET_RECRUITING
A Continuation Study of Tilrekimig in Adults With Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About This Medicine When Used for a Long Period of Time
Moderate to Severe Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic DermatitisUnlock trial analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
AsthmaUnlock trial analytics
PHASE3RECRUITING
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to-Severe Eczema
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Annualized asthma exacerbation rate over 52 weeks
Baseline through Week 52

Protocol defined asthma exacerbations require treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\<24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma.

Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
Up to 60 weeks

Number and percentage of participants with treatment-emergent adverse events. An adverse event is considered treatment-emergent if it begins or increases in severity following initiation of study intervention. Events will be summarized by severity and other protocol-defined characteristics

Number of Participants With Treatment-Emergent Serious Adverse Events During Treatment Period 1
Up to 60 weeks

Number and percentage of participants with treatment-emergent serious adverse events. Serious adverse events are events that meet one or more of the protocol-defined seriousness criteria.

Number of Participants With Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Intervention During Treatment Period 1
Up to 60 weeks

Number and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.

Number of Participants With Clinically Significant Laboratory Abnormalities During Treatment Period 1
Up to 60 weeks

Number and percentage of participants with protocol-defined clinical abnormalities in laboratory values and vitals signs. Laboratory assessments include protocol-required hematology and blood chemistry evaluations. Abnormal laboratory findings will be evaluated according to protocol-defined criteria and investigator assessment of clinical significance. Vital-sign assessments include blood pressure, pulse rate, respiratory rate, temperature, and oxygen saturation measured by pulse oximetry.

Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.
Week 16
Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo.
Week 16
Difference in the proportion of Eczema and Severity Index (EASI)75 responders between tilrekimig versus placebo
Week 16
Difference in the proportion of Validated Investigator Global Assessment (vIGA)-AD™ 0/1 responders between tilrekimig versus placebo
Week 16

Secondary Endpoints

Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts ≥300 cells/µL (ie, high eosinophil subgroup)
Baseline through Week 52
Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts <300 cells/µL (ie, medium-to-low eosinophil subgroup)
Baseline through Week 52
Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Baseline through Week 52
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Arm A TilrekimigEXPERIMENTALTilrekimig
Treatment Arm B PlaceboPLACEBO_COMPARATORPlacebo
Tilrekimig (PF-07275315)EXPERIMENTALTilrekimig (PF-07275315) subcutaneous injection (sc)
Tilrekimig - Initial treatment periodEXPERIMENTALSubcutaneous injections given over 20 Weeks.
Placebo - Initial treatment periodPLACEBO_COMPARATORSubcutaneous injections given over 22 Weeks.
Tilrekimig - Maintenance Period - Dose BEXPERIMENTALSubcutaneous injections given at Week 24 through Week 48.
Tilrekimig - Maintenance Period - Dose AEXPERIMENTALSubcutaneous injections given at Week 24 through Week 48.
Dupilumab - Initial treatment periodACTIVE_COMPARATORSubcutaneous injections given over 22 Weeks.
Placebo - Maintenance PeriodPLACEBO_COMPARATORSubcutaneous injections given at Week 24 through Week 48.
TilrekimigEXPERIMENTALSubcutaneous injections given over 20 weeks
PlaceboPLACEBO_COMPARATORSubcutaneous injections given over 20 weeks

Interventions

NameTypeDescription
tilrekimigDRUGsubcutaneous injection
PlaceboOTHERsubcutaneous injection
DupilumabDRUGSubcutaneous Injections at required timepoints based on weight and age.
Placebo for TilrekimigOTHERSubcutaneous Injections at required timepoints
Placebo for DupilumabOTHERSubcutaneous Injections at required timepoints during initial treatment period.
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Eligibility Criteria

Age Range12 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria Must meet the following asthma criteria: 1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines. 2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic...

Countries:United StatesJapan
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Recent Changes (Last 90 Days)

LOWOct 22, 2026NCT07783425lastUpdatePostDate: changed
LOWOct 22, 2026NCT07783425lastUpdatePostDate: changed
LOWOct 15, 2026NCT07765888lastUpdatePostDate: changed
LOWOct 15, 2026NCT07765888lastUpdatePostDate: changed
LOWOct 9, 2026NCT07869043NEW_TRIAL: changed
LOWOct 9, 2026NCT07869043NEW_TRIAL: changed
LOWOct 6, 2026NCT07772921Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 6, 2026NCT07783425Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 6, 2026NCT07772921Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 6, 2026NCT07783425Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 24, 2026NCT07839884NEW_TRIAL: changed
LOWSep 24, 2026NCT07839884NEW_TRIAL: changed
MEDIUMSep 4, 2026NCT07765888Status: NOT_YET_RECRUITING → RECRUITING
MEDIUMSep 4, 2026NCT07765888Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 24, 2026NCT07783425NEW_TRIAL: changed
LOWAug 24, 2026NCT07783425NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed
LOWAug 20, 2026NCT07772921NEW_TRIAL: changed

Frequently asked questions about tilrekimig and rHuPH20

What is Tilrekimig?

Tilrekimig is an investigational medicine being developed by Pfizer for respiratory and inflammatory conditions. It is in Phase 3 clinical development for severe asthma, atopic dermatitis, and moderate to severe chronic obstructive pulmonary disease. Tilrekimig has not been approved by the FDA and remains under clinical study.

What is Tilrekimig used for?

Tilrekimig is being studied for severe asthma, atopic dermatitis, and moderate to severe chronic obstructive pulmonary disease. These are the indications under investigation in Phase 3 trials. Tilrekimig is investigational and has not been approved for any use.

Who makes Tilrekimig?

Tilrekimig is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is running the Phase 3 clinical program evaluating Tilrekimig across asthma, atopic dermatitis, and chronic obstructive pulmonary disease.

What phase is Tilrekimig in?

Tilrekimig is in Phase 3 clinical development. Pfizer is running four Phase 3 trials across severe asthma, atopic dermatitis, and moderate to severe chronic obstructive pulmonary disease. Tilrekimig is investigational and has not received FDA approval.

What clinical trials is Tilrekimig in?

Tilrekimig is being evaluated in four Phase 3 trials. NCT07869043 and NCT07772921 study severe asthma, NCT07783425 studies atopic dermatitis, and NCT07839884 is a continuation study in moderate to severe chronic obstructive pulmonary disease. All are randomized, double-blind, and placebo-controlled.