A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma

NCT07772921 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C45310372026-526565-18-00
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected. The study is seeking participants who:

• Have a history of severe asthma for at least 12 months
• Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. The study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Annualized asthma exacerbation rate over 52 weeks

  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.

  Baseline through Week 52

Secondary Outcomes (36)

• 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

• CFB in Asthma Control Questionnaire (ACQ-5) at Week 52

  Baseline through Week 52

• CFB in Asthma Quality of Life Questionnaire for 12 years and older Self-Administered (AQLQ(S)-12-SA) at Week 52

  Baseline through Week 52

Study Arms (2)

Treatment Arm A Tilrekimig

EXPERIMENTAL

Tilrekimig

Drug: tilrekimig

Treatment Arm B Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

tilrekimig DRUG

subcutaneous injection

Treatment Arm A Tilrekimig

Placebo OTHER

subcutaneous injection

Treatment Arm B Placebo

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must meet the following asthma criteria:
• History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines.
• Must have experienced at least 2 asthma exacerbations requiring 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 with within 12 months of the screening visit.
• Positive bronchodilator responsiveness of FEV1 or FVC \>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol/albuterol (or equivalent SABA) at least once for spirometry conducted during screening period.
• Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions:
• Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to, chronic obstructive pulmonary disease, other emphysematous lung disease such as alpha-1 antitrypsin disease, cystic fibrosis, emphysema, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.
• Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.
• Prior/Concomitant Therapy:
• Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.
• Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40/OX40L, IL-13, IL-33 / ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.
• Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).
• Bronchial thermoplasty within the previous 24 months.
• Prior/Concurrent Clinical Study Experience:
• Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

SMS Clinical Research LLC

Garland, Texas, 75043, United States

Location

SMS Clinical Research, LLC

Mesquite, Texas, 75149, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: August 24, 2026
• Primary Completion (Estimated): June 12, 2029
• Study Completion (Estimated): September 4, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)