RecruitingPhase 3interventionalRules rewrite

Phase 3: testing tilrekimig for 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.

Official registry: https://clinicaltrials.gov/study/NCT07869043 · Pfizer · enrollment listed as 1,100

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are tilrekimig, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 1,100 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: tilrekimig, Placebo

Primary outcome (registry wording): Annualized asthma exacerbation rate over 52 weeks

Who it is for (from inclusion criteria)

Ages 12 Years to 80 Years
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
Other who can join:
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 the registry excludes

Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
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 (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

Public study contact (from the registry)

Pfizer CT.gov Call Center

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

12 listed

Asthma and Allergy Center of Chicago — River Forest, Illinois (recruiting)
Hannibal Regional Healthcare System, Inc. — Hannibal, Missouri (not_yet_recruiting)
Urban Health Plan — The Bronx, New York (not_yet_recruiting)
University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma (not_yet_recruiting)
Allergy and Clinical Immunology Associates — Pittsburgh, Pennsylvania (recruiting)
Orion Clinical Research — Austin, Texas (recruiting)
Southwest Medical Center (Building I) aka Southwest Family Medicine Associates — Dallas, Texas (not_yet_recruiting)
A & A Research Consultants, LLC — Edinburg, Texas (not_yet_recruiting)
Western Sky Medical Research — El Paso, Texas (not_yet_recruiting)
Pulmonary and Sleep Center of the Valley — McAllen, Texas (not_yet_recruiting)
DM Clinical Research — Tomball, Texas (recruiting)

+ 1 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07869043 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07869043?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07869043?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary