Registro de fonte primária
Nível de decisãoAlteração no registro do ensaio
Upstream Bio define planos de Fase 3 para verekitug em asma grave e CRSwNP
Following End-of-Phase 2 FDA meetings, Upstream Bio will run one placebo-controlled Phase 3 trial per indication using a single 400 mg subcutaneous dose every 12 weeks in broad populations without biomarker restriction. Both trials are scheduled to start in Q1 2027, with the asthma trial measuring AAER at 48 weeks and the CRSwNP trial measuring NPS and NCS at 48 weeks.
Fatos principais
- Arquivado
- 1 de set. de 2026, 11:05
- Evento
- Alteração no registro do ensaio
- Direção
- Positivo
- Empresa
UPBUpstream Bio- Ativo
- verekitug
- Fonte
- SEC 8-K
- Confiança
- Com fonte
- Dose
- 400 mg a cada 12 semanas
- pacientes com asma
- aproximadamente 1.500 no total em ambos os ensaios
- endpoint primário asma
- taxas anualizadas de exacerbação de asma (AAER) ao longo de 48 semanas
- endpoints primários crswp
- alteração desde o início no escore de pólipos nasais (NPS) e escore de congestão nasal (NCS) cada um em 48 semanas
Trecho da fonte
EX-99.1 2 upb-ex99_1.htm EX-99.1 EX-99.1 Upstream Bio Announces Pivotal Phase 3 Development Plans for Verekitug in Both Severe Asthma and CRSwNP – Following productive FDA discussions, Upstream Bio will study 400mg of verekitug administered every 12 weeks, versus placebo, in severe asthma and CRSwNP with one pivotal Phase 3 trial in each indication – – The Company’s Phase 3 strategy is designed to deliver best-in-class efficacy across both indications by evaluating a high-dose, quarterly regimen of verekitug in broad patient populations – – The Company remains on track to initiate both Phase 3 trials in Q1 2027 – WALTHAM, Mass. – September 1, 2026 - Upstream Bio, Inc. (Nasdaq: UPB), a clinical-stage company developing treatments for severe inflammatory respiratory diseases, today ann