Five Ongoing Severe Asthma Clinical Trials in the United States

Regarding severe asthma, it is essential for clinicians to remain informed about emerging clinical trial opportunities and the resulting data that may lead to new intensive treatment strategies, affect clinical guidelines, and ultimately improve patient outcomes.

Today, we have a rundown of five, ongoing Phase 2, 3 clinical trials focusing on severe asthma, in the United States. While most trials featured below are specifically for severe asthma, some overlap with moderate asthma, as well. These trials' estimated primary completions range from March 2027 through January 2029, and they are sorted by start date.

Featured Severe Asthma Clinical Trials

Severe Asthma Clinical Trials Rundown

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)

• Sponsor: Generate Biomedicines
• Goal: The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
• Interventions: GB-0895, placebo
• Primary Outcome Measure: To evaluate the annualized asthma exacerbation rate in adult and adolescent subjects with severe uncontrolled asthma.
• Time Frame: From day one (randomization) to week 52.
• Study Details
• Source

A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)

• Sponsor: Generate Biomedicines
• Goal: The objective of this study is to assess the potential for GB-0895 treatment to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.
• Interventions: GB-0895, placebo
• Primary Outcome Measure: To evaluate the annualized asthma exacerbation rate in adult and adolescent subjects with severe uncontrolled asthma.
• Time Frame: From day one (randomization) to week 52.
• Study Details
• Source

Study to Evaluate the Safety, Pharmacology and Efficacy of WIN378 in Adults With Moderate or Severe Asthma

• Sponsor: Windward Bio
• Goal: The study will test how doses of WIN378 are handled by your body (pharmacokinetics) and assess the safety of the medicine and will assess markers of asthma inflammation in your breath and in your blood, lung function and asthma control (pharmacodynamics).
• Interventions: WIN378, placebo
• Primary Outcome Measures: Number of participants with treatment-emergent adverse events (TEAEs) during the study; Number of participants with treatment-emergent serious adverse events (TESAEs) during the study; Number of participants with abnormal vital signs during the study; Number of participants with abnormal laboratory assessments during the study; Number of participants with Clinically significant abnormal ECG results during the study; WIN 378 Pharmacokinetics: concentration at trough [Ctrough]; WIN 378 Pharmacokinetics: area under the concentration time curve [AUC]; WIN 378 Pharmacokinetics: maximum observed concentration [Cmax]); Number of participants with positive anti-drug antibodies (ADA) during the study. 
• Time Frame: (Note: all timeframes for primary outcome measures are Week 0 - Week 60.)
• Study Details
• Source

A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma

• Sponsor: Pfizer
• Goal: The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. 
• Interventions: PF-07275315
• Primary Outcome Measure: 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.
• Time Frame: Week 12; Baseline through Week 24; Baseline through Week 24; Baseline through Week 24; Baseline through Week 24.
• Study Details
• Source

A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants With Severe Asthma (VALOUR)

• Sponsor: Upstream Bio Inc.
• Goal: The primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (UPB-101) in participants who complete the VALIANT study (NCT06196879).
• Interventions: Verekitug, placebo
• Primary Outcome Measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs).
• Time Frame: From VALOUR baseline up to week 64.
• Study Details
• Source

Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. (ARRIVAL)

• Sponsor: AstraZeneca
• Goal: The objective of this study is to assess the potential for tezepelumab-treated patients (subcutaneous administration) to reduce maintenance therapy without loss of asthma control in adolescent and adults with severe asthma.
• Interventions: Tezepelumab, budesonide/formoterol, albuterol/budesonide (AIRSUPRA®), mannitol, salbutamol
• Primary Outcome Measure: Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase.
• Time Frame: Week 56
• Study Details
• Source

Related Guidelines:

• Biologic Management in Severe Asthma for Adults
  • American College of Chest Physicians (CHEST), September 2025

• Management of Severe Asthma
  • American Thoracic Society (ATS), European Respiratory Society (ERS), October 2019

Sign up for alerts and stay informed on the latest published guidelines.

Copyright © 2026 Guideline Central, all rights reserved.