Novartis registers Phase 3 urticaria, pruritus trials; posts malaria and leishmaniasis data

Novartis had an active week on ClinicalTrials.gov, with two new Phase 3 registrations, a malaria cohort marked completed, and a first-in-human leishmaniasis study posted with final results.

• Novartis registered a global, open-label Phase 3 study testing a treatment algorithm that sequences remibrutinib and omalizumab in adults with chronic spontaneous urticaria not adequately controlled by H1-antihistamines.¹ The study is not yet recruiting, with an estimated enrollment of 382 participants¹ and a primary endpoint of the proportion of participants achieving Urticaria Activity Score over 7 days (UAS7) ≤6 at Week 24¹.
• Novartis also registered a 52-week Phase 3 study evaluating the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO)². The trial is recruiting, with planned enrollment of 180 participants² and a primary endpoint of the proportion of participants achieving a ≥4 point reduction from baseline in Worst Itch Numerical Rating Scale (WI NRS) at Week 12².
• A Phase 2 malaria cohort has finished. Cohort B1 of the Platform study evaluated the efficacy and safety of INE963 plus Cipargamin in participants with uncomplicated Plasmodium falciparum malaria³, and the record lists the study as completed with 95 participants (actual)³ enrolled.
• A related malaria cohort is underway. Cohort C2 of the same Platform study is evaluating Cipargamin plus KLU156 in participants with uncomplicated Plasmodium falciparum malaria⁴, currently recruiting toward an estimated enrollment of 120 participants⁴.
• Novartis posted a completed first-in-human study for a leishmaniasis candidate. The Phase 1 trial assessed the safety, tolerability and pharmacokinetics of LXE408 in healthy subjects⁵, aiming to support further clinical development of LXE408 for the treatment of patients with visceral leishmaniasis and potentially Chagas disease⁵. The study is listed as completed with 88 participants (actual)⁵ enrolled.