SOLAIRIA-2

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

• IRAS ID

  1013385

• Contact name

  Generate Biomedicines Generate Biomedicines

• Contact email

  clinicaltrials@generatebiomedicines.com

• Sponsor organisation

  Generate Biomedicines

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  NCT07359846

• Research summary

  Severe asthma is a condition that affects the lungs. People with severe asthma often have symptoms, such as wheezing, shortness of breath, chest tightness, and cough. Available medicines for the treatment of severe asthma are mostly drugs that relax airway muscles making it easier to breathe (bronchodilators) and drugs that reduce airway inflammation (such as corticosteroids). However, these medicines may not control asthma symptoms well enough. Therefore, there is a need to find other medicines for the treatment of severe asthma.
  GB-0895 is a new drug being developed for treating people with severe asthma. It is not yet approved for treating asthma. GB-0895 is an antibody (protein) made in a lab that blocks the action of thymic stromal lymphopoietin (TSLP). TSLP is a protein made by cells in the airways. It plays an important role in causing inflammation in asthma. GB-0895 binds very strongly to TSLP, stopping it from causing inflammation. Researchers think that GB-0895 might help in the treatment of patients with severe asthma who are also taking their regular asthma medications.
  A total of approximately 786 participants globally will take part in this study. Participants will be assigned to one of the 2 treatment groups by chance. There will be about 524 participants in the group receiving GB-0895 and about 262 participants in the group receiving placebo. This is a double-blind study which means neither the participants nor the study doctors will know who is receiving GB-0895 or a placebo. For participants not entering the OLE, the study will last about 96 weeks (about 24 months) with up to 13 expected visits to the clinic. After completing the main study, participants may be able to continue in an optional open-label study where all participants will receive GB-0895 for 1 year and then will complete a 38-week follow-up period.

• REC name

  Wales REC 5

• REC reference

  26/WA/0052

• Date of REC Opinion

  14 Apr 2026

• REC opinion

  Further Information Favourable Opinion