7 results
Primary objective:To demonstrate that Eziclen, given on the day before colonoscopy has non-inferior efficacy to Klean-Prep on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight > 40 kg, scheduled to undergo a…
Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…
Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1), administered once daily (QD) or twice…
Primary:1. To characterize the safety and tolerability of multiple oral doses of K-196 alone and in combination with naproxen/omeprazole in healthy subjects.Secondary:1. To assess the effects of K-196 compared to placebo on the proportion of…
Cohorts 1, 2, and 3 only:The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3)…
2. Objective of the study (in English): The main purpose of this study is to determine the anti-tumor effects of TAR-200 + IV cetrelimab (cohort 1) and IV cetrelimab alone (cohort 2).The secondary objectives are to evaluate the safety and…
The purpose of this study is to compare event-free survival (EFS) in participants with Bacillus Calmette-Guerin (BCG)-naive high-risk non-muscle invasive bladder cancer (HR-NMIBC), including high-grade papillary Ta, any T1, or carcinoma in situ (CIS…