Approval Probability
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Also known as PF-07275315
Tilrekimig · 8 trials · 3 indications
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 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 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 and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.
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.
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry.
Exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) are sudden worsening of respiratory symptoms that significantly worsen lung function and quality of life.
FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV1 is obtained from spirometry.
Incidence of treatment-emergent AEs, treatment-emergent SAEs, and treatment-emergent AEs/SAEs leading to treatment discontinuation
Incidence of clinically significant changes in laboratory tests
Incidence of clinically significant changes in vital signs
Incidence of clinically significant changes in ECG
EASI75 (≥75% improvement from baseline) at Week 16
| Arm | Type | Description |
|---|---|---|
| Treatment Arm A Tilrekimig | EXPERIMENTAL | Tilrekimig |
| Treatment Arm B Placebo | PLACEBO_COMPARATOR | Placebo |
| Tilrekimig (PF-07275315) | EXPERIMENTAL | Tilrekimig (PF-07275315) subcutaneous injection (sc) |
| Tilrekimig - Initial treatment period | EXPERIMENTAL | Subcutaneous injections given over 20 Weeks. |
| Placebo - Initial treatment period | PLACEBO_COMPARATOR | Subcutaneous injections given over 22 Weeks. |
| Tilrekimig - Maintenance Period - Dose B | EXPERIMENTAL | Subcutaneous injections given at Week 24 through Week 48. |
| Tilrekimig - Maintenance Period - Dose A | EXPERIMENTAL | Subcutaneous injections given at Week 24 through Week 48. |
| Dupilumab - Initial treatment period | ACTIVE_COMPARATOR | Subcutaneous injections given over 22 Weeks. |
| Placebo - Maintenance Period | PLACEBO_COMPARATOR | Subcutaneous injections given at Week 24 through Week 48. |
| Tilrekimig | EXPERIMENTAL | Subcutaneous injections given over 20 weeks |
| Placebo | PLACEBO_COMPARATOR | Subcutaneous injections given over 20 weeks |
| Phase 3 Treatment Arm A | EXPERIMENTAL | - |
| Phase 2 Treatment Arm B | EXPERIMENTAL | - |
| Phase 2 Treatment Arm A | EXPERIMENTAL | - |
| Phase 3 Treatment Arm B | PLACEBO_COMPARATOR | - |
| Phase 2 Treatment Arm C | PLACEBO_COMPARATOR | - |
| Treatment Arm A | EXPERIMENTAL | PF-07275315 |
| Treatment Arm B | EXPERIMENTAL | PF-07275315 |
| Treatment Arm C | EXPERIMENTAL | PF-07275315 |
| Treatment Arm D | PLACEBO_COMPARATOR | Placebo |
| Stage 1_PF-07275315 | EXPERIMENTAL | Stage 1 PF-07275315 Injections over 12 weeks |
| Stage 1_PF-07264660 | EXPERIMENTAL | Stage 1 PF-07264660 Injections over 12 weeks |
| Stage 1_Placebo | EXPERIMENTAL | Stage 1 Placebo Injections over 12 weeks |
| Stage 2_PF-07275315 _Dose A | EXPERIMENTAL | Stage 2 PF-07275315 Injections over 12 weeks. |
| Stage 2_PF-07275315 _Dose B | EXPERIMENTAL | Stage 2 PF-07275315 Injections over 12 weeks. |
| Stage 2_PF-07275315 _Dose C | EXPERIMENTAL | Stage 2 PF-07275315 Injections over 12 weeks. |
| Stage 2_PF-07275315 _Dose D | EXPERIMENTAL | Stage 2 PF-07275315 or PF-07264660 Injections over 12 weeks. |
| Stage 2_Placebo | EXPERIMENTAL | Stage 2 Placebo Injections over 12 weeks. |
| Stage 3_Placebo+PF-07275315_Dose A | EXPERIMENTAL | Stage 3 Placebo Injections for 16 weeks followed by PF-07275315 Injections for 16 weeks. |
| Stage 3_PF-07275315_Dose B | EXPERIMENTAL | Stage 3 PF-07275315 Injections for 32 weeks. |
| Stage 4_PF-07264660_Dose A | EXPERIMENTAL | Stage 4 PF-07264660 Injections for 12 weeks |
| Stage 4_PF-07264660_Dose B | EXPERIMENTAL | Stage 4 PF-07264660 Injections for 12 weeks |
| Stage 4_PF-07264660_Dose C | EXPERIMENTAL | Stage 4 PF-07264660 Injections for 12 weeks |
| Stage 4_Placebo | EXPERIMENTAL | Stage 2 Placebo Injections for 12 weeks |
| Name | Type | Description |
|---|---|---|
| tilrekimig | DRUG | subcutaneous injection |
| Placebo | OTHER | subcutaneous injection |
| Dupilumab | DRUG | Subcutaneous Injections at required timepoints based on weight and age. |
| Placebo for Tilrekimig | OTHER | Subcutaneous Injections at required timepoints |
| Placebo for Dupilumab | OTHER | Subcutaneous Injections at required timepoints during initial treatment period. |
| PF-07275315 dose 1 | DRUG | SC injection dose 1 |
| PF-07275315-dose 2 | DRUG | SC injection dose 2 |
| PF-07275315-dose 3 | DRUG | SC injection dose 3 |
| PF-07275315 | DRUG | subcutaneous injection |
| PF-07264660 | DRUG | subcutaneous injection |
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...
Top 16 of 18 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 5 | PHASE3 | QVM149, QMF149, Glycopyrronium bromide |
| GSK plc Sponsored ADR | GSK | 10 | PHASE3 | Trelegy Ellipta, Depemokimab, HFA-152a, GSK5784283, Ventolin |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 4 | PHASE3 | TEV-56248, ProAir (albuterol sulfate eMDPI), Budesonide/Formoterol SPIROMAX, Reslizumab |
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Dupilumab, Lunsekimig |
| AstraZeneca PLC | AZN | 28 | PHASE3 | Benralizumab, Tezepelumab, Budesonide/formoterol, Albuterol/budesonide, PT007 |
| Pfizer Inc. | PFE | 4 | PHASE3 | Tilrekimig, PF-07275315, PF-08103402 |
| Generate Biomedicines, Inc. | GENB | 3 | PHASE3 | GB-0895 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE2 | KT-621 |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Brenipatide |
| Incyte Corporation | INCY | 1 | PHASE2 | povorcitinib |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE2 | ARO-RAGE |
| Amgen Inc. | AMGN | 1 | PHASE1 | AMG 691 |
| Johnson & Johnson | JNJ | 1 | PHASE2 | JNJ-95597528 |
| Apogee Therapeutics, Inc. | APGE | 1 | PHASE1 | APG777 |
| Celldex Therapeutics, Inc. | CLDX | 1 | PHASE1 | CDX-622 |
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.
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.
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.
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.
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.