AstraZeneca posts NATRON Phase III benralizumab results; registers ROSY-S anifrolumab rollover study

This week's AstraZeneca-linked trial registry activity covers one Phase III results posting, several new registrations, and one collaborator-only study.

• Benralizumab, Phase III, hypereosinophilic syndrome (HES): results were first posted for the "NATRON" trial (NCT04191304). The study is designed so that approximately 120 patients will be randomised at a 1:1 ratio at the randomisation/baseline visit to receive either benralizumab or matching placebo Q4W for a 24-week DB treatment period.¹ The primary database lock will occur when approximately 38 patients have had their first HES worsening/flare event during the DB treatment period and all randomised patients have had the opportunity to be followed up for the 24-week DB treatment period.¹
• Anifrolumab (Saphnelo), Phase III, rollover access study: AstraZeneca registered "ROSY-S" (NCT07691970), not yet recruiting. The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.² Estimated enrollment is 1072 participants across conditions including systemic sclerosis, cutaneous lupus, myopathies and systemic lupus erythematosus.²
• Anifrolumab, Phase I, systemic lupus erythematosus: AstraZeneca registered a new PK/PD study (NCT07688980) comparing subcutaneous and intravenous administration, not yet recruiting, with an estimated enrollment of 92 participants.³ The primary outcome is anifrolumab serum concentrations through Week 4, to characterise the PK exposure of SC or IV anifrolumab.³
• Baxdrostat, Phase IIIb, uncontrolled hypertension in Chinese participants: AstraZeneca registered "BaxNoD" (NCT07686120), not yet recruiting, with collaborator Tigermed Consulting. The trial will compare baxdrostat 2mg versus placebo, administered QD orally, on the reduction of ambulatory 24-hour average SBP in participants with uHTN,⁴ with an estimated enrollment of 286 participants.⁴
• AZD2389, Phase 2a, liver fibrosis and compensated cirrhosis: results were posted for the completed "BORANA" trial (NCT06750276), which measured the safety, tolerability, and the way the body absorbs, distributes, and metabolises AZD2389 as compared to placebo in participants with liver fibrosis and compensated cirrhosis,⁵ with an enrollment of 40 participants (actual).⁵
• Ocular imaging, observational pilot study, transthyretin amyloid cardiomyopathy (ATTR-CM): AstraZeneca registered a new study (NCT07690436), now recruiting, with an estimated enrollment of 500 participants.⁶ Ocular imaging and other study data will be collected to assess the feasibility of developing and preliminarily evaluating a machine learning model to discriminate ATTR-CM cases from HF controls without ATTR-CM.⁶
• AZD4144, Phase I, healthy participants: a drug-drug interaction study (NCT07685600) is recruiting to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants,⁷ with an estimated enrollment of 32 participants.⁷
• T-DXd (trastuzumab deruxtecan), Phase 3b, HER2+/HR+ metastatic breast cancer: sponsor Daiichi Sankyo registered "DB-Guide" (NCT07683754), not yet recruiting, with an estimated enrollment of 200 participants;⁸ AstraZeneca is a collaborator.
• Robotic bronchoscopy diagnostics, "ARTEMIS" trial (NCT07685977): sponsor Vanderbilt University Medical Center registered this randomized controlled trial, not yet recruiting, with an estimated enrollment of 400 participants;⁹ AstraZeneca is a collaborator.