Boehringer posts Phase III AIRWARD COPD trial for verducatib; also lists Phase I BI 3821001 study

Boehringer Ingelheim's registry activity this week includes one new Phase III trial, one new Phase I trial, and two ongoing oncology studies.

• Boehringer Ingelheim registered "The AIRWARD Study" (NCT07907991), a Phase III trial of verducatib in chronic obstructive pulmonary disease (COPD). The trial aims to find out whether verducatib helps people with COPD have fewer flare-ups or sudden worsening of COPD symptoms over up to about 1.5 years, compared with placebo.¹ It is listed as not yet recruiting, with an estimated enrollment of 1800 participants.¹
• Boehringer Ingelheim also registered "A Study to Test How Well Different Doses of BI 3821001 Are Tolerated by Healthy People" (NCT07908004), a Phase I trial. The study is described as a Phase I single-blind, randomised, placebo-controlled, parallel group design trial to investigate the safety, tolerability and pharmacokinetics of multiple rising doses of BI 3821001 administered to healthy trial participants.² It is not yet recruiting, with an estimated enrollment of 40 participants.²
• Boehringer Ingelheim's Phase Ia trial of BI 3968621 (NCT07851103), alone or with ezabenlimab in advanced solid tumours, remains recruiting. The study is a first-in-human, multicentre, Phase Ia dose escalation study of BI 3968621 as monotherapy and in combination with ezabenlimab to investigate safety, tolerability, pharmacokinetics, and preliminary antitumour activity in patients with advanced solid tumours,³ with an estimated enrollment of 90 participants.
• Boehringer Ingelheim's Beamion LUNG-1 trial (NCT04886804) of zongertinib in HER2-altered solid tumors also remains recruiting. The study is described as an open label, Phase I dose escalation trial, with dose confirmation and expansion, of zongertinib (BI 1810631) as monotherapy in patients with advanced or metastatic solid tumors with HER2 aberrations,⁴ with an estimated enrollment of 554 participants.