Phase 2 Asthma Trial, Recruiting NCT06977581 Sponsor: Pfizer Condition: Asthma
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Phase 2 Asthma Trial, Recruiting

NCT06977581
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have had moderate-to-severe asthma that has persisted for at least 12 months before the screening appointment.
  • You have had at least one asthma flare-up in the past 12 months that required treatment with steroid tablets or injections for 3 or more days.
  • Your breathing test results (measured before using a reliever inhaler) fall within a specific range — between 30% and 80% of what is considered normal for someone your age and size (confirm with trial site).
  • Your breathing test shows a meaningful improvement after using a reliever inhaler — specifically, a 12% or more increase in airflow plus a specific volume increase (confirm with trial site).
  • You have been taking a medium-to-high dose combination inhaler (containing both a steroid and a long-acting reliever) for at least 12 months, with the same dose for at least the past 3 months.
  • Your asthma symptom score on a standard questionnaire (called ACQ-5) is 1.5 or higher at the screening visit and before being assigned to a treatment group.
  • Your body mass index (BMI) — a measure of weight relative to height — is between 18 and 40.

Who may not be able to join:

  • You have any medical or mental health condition, or recent (within the past year) or current thoughts of self-harm or suicide, that could make participation risky or unsuitable, as judged by the study doctor.
  • You have been diagnosed with or shown signs of any lung disease other than asthma — such as COPD, emphysema, cystic fibrosis, pulmonary fibrosis, or certain other lung conditions — based on symptoms, breathing tests, or scans within the past 12 months.
  • You have or have recently had certain infections, including: a parasitic or worm infection requiring treatment in the past 2 weeks; an infection requiring hospital stay or intravenous antibiotics in the past 60 days; or any serious or unusual infection in the past 6 months.
  • You are currently taking, or have previously taken, any medication that is not allowed in this study, or you are unable or unwilling to take a medication that is required.
  • You have ever used, or are currently using, any approved or experimental biologic medicine (such as treatments targeting certain immune system proteins) or certain targeted tablets (such as JAK inhibitors) for asthma or related allergic conditions.
  • You have taken steroid tablets, injections, or joint injections at any dose within 28 days before the screening visit.
  • You have received immunoglobulin therapy (a type of immune protein given by drip or injection) within the past 12 weeks, or have plans to receive it during the study.
  • You have had a severe allergic reaction (anaphylaxis) to any antibody-based medicine, or to the specific study drug or its ingredients.
  • You have had a procedure called bronchial thermoplasty (a treatment applied to the airways) within the past 24 months.
  • You have taken part in another clinical trial or received an experimental drug within 30 days (or longer, depending on the drug) before screening, or plan to join another drug or vaccine study during this trial.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

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Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
20 May 2025
Est. completion
8 March 2027

Where this trial is recruiting

🇦🇷 Argentina 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇳 China 🇨🇿 Czechia 🇭🇺 Hungary 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12; Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation; Clinically significant, treatment-related laboratory abnormalities; Clinically significant, treatment-related abnormalities in vital signs; Clinically significant, treatment-related electrocardiogram (ECG) abnormalities

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov