XTMAB-16-201: A seamless, Phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

This is a seamless, Phase 1b/2 Multiple Ascending Dose (MAD) / Proof of Concept (POC) Study (hereafter referred to as Phase 2 Program) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary involvement. The study is comprised of two parts: Part A is a randomized double-blind placebo-controlled multiple dose-escalating study, and Part B is a randomized double-blind placebo-contolled POC study. The objective of Part A is to evaluate the safety and tolerability of MADs of XTMAB-16, and to determine the recommended Phase 2 dose and frequency for Part B for XTMAB-16 administration in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations. The objective of Part B is to confirm preliminary efficacy of XTMAB-16 as measured by the ability to reduce background oral corticosteroid use in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations. The rationale for this study is to conduct dose range finding to identify the recommended Phase 2 dose (RP2D) for Part B and characterize a variety of clinical and biomarker outcome measures to demonstrate efficacy and POC for XTMAB-16 in this patient population.

Scholars @ ECU