117 results
Primary: - To assess the effect of TAK-861 on excessive daytime sleepiness (EDS) as measured by sleep latency from the Maintenance of Wakefulness Test (MWT).Please refer to the Study protocol for detailed description on the secondary Objective of…
primary objective:To assess the long-term safety and tolerability of mavacamten in participants with hypertrophic cardiomyopathy (HCM) previously enrolled in 1 of 2 placebo-controlled trials: MAVERICK-HCM (MYK-461-006) for non-obstructive HCM (nHCM…
The objective of Substudy 1 (randomized, double-blind, placebo-controlled maintenance) is to evaluate the efficacy and safety of two doses of upadacitinib versus placebo as maintenance therapy in subjects with moderately to severely active Crohn…
To evaluate the safety and tolerability of long term treatment with ontamalimab in subjects with moderate to severe UC or CD.
Primary:Phase I: • To identify the maximum tolerated dose (MTD) and/or Recommended Phase II dose (RP2D) of [177Lu]-NeoB Phase IIa:• Cohort A, B, C: To assess the Disease Control Rate (DCR) of [177Lu]-NeoB at the RP2D• Cohort D: To assess the PK as…
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in subjects with moderately and severely active Crohn's disease (CD).
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
Primary objective: To evaluate the effect of ravulizumab compared with placebo on amyotrophic lateral sclerosis functional rating scale-revised (ALSFRS-R) score in adult patients with amyotrophic lateral sclerosis (ALS).Secondary objectives:1. To…
The primary objective of this study is to assess the efficacy of twice-weekly SC doses of pegcetacoplan compared with that of placebo in patients with primary C3G or IC-MPGN on the basis of a reduction in proteinuria in the setting of stable or…
To evaluatie the long term safety of treatment with osilodrostat for patients with Cushing Syndrome. In addition to evaluating the proportion of patients with clinical benefit (as assessed by the investigator) and determening frequency, severity and…
The objective of the study is to assess the efficacy and safety of upadacitinib combined with topical corticosteroids (TCS) for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
Primary ObjectiveThe primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB IVB) MF or SS that have achieved disease…
The primary objective is to compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab…
Primary* To assess safety and tolerability of IBC-Ab002 following single and multiple ascending doses in persons with early ADSecondary* To assess the pharmacokinetics of IBC-Ab002 following a single and multiple ascending doses in persons with…
Primary objectivesPart 1 Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and LAVA-1207 plus pembrolizumab• To investigate the safety and tolerability of treatment in patients with therapy refractory mCRPC.• To determine the…
This is a first-in-human Phase Ia/Ib, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of RO7502175 as a single…
The objective of this study is to evaluate the effects of sotatercept treatment (plus background PAH therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are…