AsthmaPhase 3NCT07772921
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
A Phase 3 study testing tilrekimig in people with Asthma, run by Pfizer at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- tilrekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 20 Aug 2026to 24 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Other Inclusion Criteria:
- 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).
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Kern Research, Inc.
Bakersfield, California, 93301
- Recruiting
SMS Clinical Research LLC
Garland, Texas, 75043
- Recruiting
SMS Clinical Research, LLC
Mesquite, Texas, 75149
- Recruiting
Innovations Biotech
Miami, Florida, 33186
- Recruiting
Monroe Biomedical Research
Monroe, North Carolina, 28112
- Recruiting
Hudson County Clinical Trials Research Center, LLC
Union City, New Jersey, 07087
- Recruiting
Chesapeake Clinical Research, Inc.
White Marsh, Maryland, 21162
Japan1 site, 1 recruiting
- Not yet recruiting
Showa Medical University Hospital
Shinagawa, Tokyo, 142-8666
About this study
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA
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:
Read more
- 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
- Being tested
- tilrekimig, Placebo
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tilrekimigDrug
subcutaneous injection
PlaceboOther
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm A Tilrekimig | Experimental | Tilrekimig Receives: Drug: tilrekimig |
| Treatment Arm B Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: Baseline through Week 52
Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Measured: Baseline through Week 52
CFB in Asthma Control Questionnaire (ACQ-5) at Week 52
Measured: 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
Measured: Baseline through Week 52
Annualized asthma exacerbation rate associated with emergency room (ER)/urgent care (UC) visit or hospitalization over 52 weeks
Measured: Baseline through Week 52
Time to first asthma exacerbation
Measured: Baseline through Week 52
CFB in weekly mean Asthma Nighttime Symptom Diary (ANSD) at Week 52
Measured: Baseline through Week 52
CFB in weekly mean Asthma Daytime Symptom Diary (ADSD) at Week 52
Measured: Baseline through Week 52
Clinical remission at Week 52
Measured: Week 52
CFB in pre-bronchodilator FEV1 at all time points (other than Week 52)
Measured: Baseline through Week 52
CFB in ACQ-5 all time points (other than Week 52)
Measured: Baseline through Week 52
CFB in AQLQ(S)-12-SA at all time points (other than Week 52
Measured: Baseline through Week 52
CFB in weekly mean ANSD at all time points (other than Week 52)
Measured: Baseline through Week 52
CFB in weekly mean ADSD at all time points (other than Week 52)
Measured: Baseline through Week 52
CFB in pre-bronchodilator % Predicted FEV1 at all time points
Measured: Baseline through Week 52
CFB in pre-bronchodilator forced vital capacity (FVC) at all time points
Measured: Baseline through Week 52
CFB in pre-bronchodilator % Predicted FVC at all time points
Measured: Baseline through Week 52
CFB in pre-bronchodilator FEV1/FVC ratio at all time points
Measured: Baseline through Week 52
CFB in post-bronchodilator FEV1 at all time points
Measured: Baseline through Week 52
CFB in post-bronchodilator % Predicted FEV1 at all time points
Measured: Baseline through Week 52
CFB in post-bronchodilator FVC at all time points
Measured: Baseline through Week 52
CFB in post-bronchodilator % Predicted FVC at all time points
Measured: Baseline through Week 52
CFB in post-bronchodilator FEV1/FVC ratio at all time points
Measured: Baseline through Week 52
ACQ-5 response: decrease from baseline in ACQ-5 ≥ 0.5 at all time points
Measured: Baseline through Week 52
AQLQ response: increase from baseline in AQLQ(S)-12-SA≥ 0.5 at all time points
Measured: Baseline through Week 52
Time to first asthma exacerbation associated with ER/UC visit or hospitalization
Measured: Baseline through Week 52
Clinical remission at Week 24
Measured: Baseline through Week 24
Event of ≥1 asthma exacerbation over 52 weeks
Measured: Baseline through Week 52
Event of ≥1 asthma exacerbation associated with ER/UC visit or hospitalization over 52 weeks
Measured: Baseline through Week 52
CFB in Patient Global Impression of Severity (PGI-S) at all time points
Measured: Baseline through Week 52
Patient Global Impression of Change (PGI-C) at all time points
Measured: Baseline through Week 52
Annualized asthma exacerbation rate over 52 weeks by baseline FeNO subgroup (<25 ppb, ≥25 to <50 ppb, ≥50 ppb)
Measured: Baseline through Week 52
Incidence and severity of treatment-emergent adverse events (TEAEs).
Measured: Baseline through Week 64
Incidence of treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuation.
Measured: Baseline through Week 64
Incidence of clinical abnormalities in clinical laboratory values, vital signs or electrocardiograms
Measured: Baseline through Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start20 Aug 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion24 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772921
- Sponsor's protocol ID
- C4531037
- Other IDs
- 2026-526565-18-00
- Status last verified
- Oct 2026
- First submitted
- 14 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA
- ClinicalTrials.gov ID
- NCT07772921
- Acronym / sponsor ID
- C4531037
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 24 Aug 2029 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm A Tilrekimig | Experimental | Drug: tilrekimigTilrekimig |
| Treatment Arm B Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (11 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tilrekimigsubcutaneous injection | Drug | Treatment Arm A Tilrekimig |
| Placebosubcutaneous injection | Other | Treatment Arm B Placebo |
Primary outcome
Annualized asthma exacerbation rate over 52 weeks
Time frame: 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.
36 secondary outcomes
Annualized asthma exacerbation rate over 52 weeks in participants with severe asthma and with eosinophil counts ≥300 cells/µL (ie, high eosinophil subgroup)
Time frame: 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)
Time frame: Baseline through Week 52
Change from baseline (CFB) in pre-bronchodilator forced expiratory volume in 1 second (FEV1) at Week 52
Time frame: Baseline through Week 52
CFB in Asthma Control Questionnaire (ACQ-5) at Week 52
Time frame: 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
Time frame: Baseline through Week 52
Annualized asthma exacerbation rate associated with emergency room (ER)/urgent care (UC) visit or hospitalization over 52 weeks
Time frame: Baseline through Week 52
Time to first asthma exacerbation
Time frame: Baseline through Week 52
CFB in weekly mean Asthma Nighttime Symptom Diary (ANSD) at Week 52
Time frame: Baseline through Week 52
CFB in weekly mean Asthma Daytime Symptom Diary (ADSD) at Week 52
Time frame: Baseline through Week 52
Clinical remission at Week 52
Time frame: Week 52
CFB in pre-bronchodilator FEV1 at all time points (other than Week 52)
Time frame: Baseline through Week 52
CFB in ACQ-5 all time points (other than Week 52)
Time frame: Baseline through Week 52
CFB in AQLQ(S)-12-SA at all time points (other than Week 52
Time frame: Baseline through Week 52
CFB in weekly mean ANSD at all time points (other than Week 52)
Time frame: Baseline through Week 52
CFB in weekly mean ADSD at all time points (other than Week 52)
Time frame: Baseline through Week 52
CFB in pre-bronchodilator % Predicted FEV1 at all time points
Time frame: Baseline through Week 52
CFB in pre-bronchodilator forced vital capacity (FVC) at all time points
Time frame: Baseline through Week 52
CFB in pre-bronchodilator % Predicted FVC at all time points
Time frame: Baseline through Week 52
CFB in pre-bronchodilator FEV1/FVC ratio at all time points
Time frame: Baseline through Week 52
CFB in post-bronchodilator FEV1 at all time points
Time frame: Baseline through Week 52
CFB in post-bronchodilator % Predicted FEV1 at all time points
Time frame: Baseline through Week 52
CFB in post-bronchodilator FVC at all time points
Time frame: Baseline through Week 52
CFB in post-bronchodilator % Predicted FVC at all time points
Time frame: Baseline through Week 52
CFB in post-bronchodilator FEV1/FVC ratio at all time points
Time frame: Baseline through Week 52
ACQ-5 response: decrease from baseline in ACQ-5 ≥ 0.5 at all time points
Time frame: Baseline through Week 52
AQLQ response: increase from baseline in AQLQ(S)-12-SA≥ 0.5 at all time points
Time frame: Baseline through Week 52
Time to first asthma exacerbation associated with ER/UC visit or hospitalization
Time frame: Baseline through Week 52
Clinical remission at Week 24
Time frame: Baseline through Week 24
Event of ≥1 asthma exacerbation over 52 weeks
Time frame: Baseline through Week 52
Event of ≥1 asthma exacerbation associated with ER/UC visit or hospitalization over 52 weeks
Time frame: Baseline through Week 52
CFB in Patient Global Impression of Severity (PGI-S) at all time points
Time frame: Baseline through Week 52
Patient Global Impression of Change (PGI-C) at all time points
Time frame: Baseline through Week 52
Annualized asthma exacerbation rate over 52 weeks by baseline FeNO subgroup (<25 ppb, ≥25 to <50 ppb, ≥50 ppb)
Time frame: Baseline through Week 52
Incidence and severity of treatment-emergent adverse events (TEAEs).
Time frame: Baseline through Week 64
Incidence of treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuation.
Time frame: Baseline through Week 64
Incidence of clinical abnormalities in clinical laboratory values, vital signs or electrocardiograms
Time frame: Baseline through Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tilrekimig in people with Asthma, run by Pfizer at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annualized asthma exacerbation rate over 52 weeks (time frame: Baseline through Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.