25 results
The objectives of Part B of the study are as follows: Primary: To assess the safety and tolerability of CALY-002 following multiple ascending doses administered IV in subjects with coeliac disease (CeD). Secondary: (1) To characterise the PK of CALY…
Core Primary Objectives:1. To investigate the safety and tolerability of EP0042 given alone or in combination with anti-cancer treatments.Module 1 Primary Objectives:1. To investigate the safety and tolerability of EP0042 given as a monotherapy in…
Primary Objective:To assess the safety and tolerability and determine the MTD and the RP2D of CB307 in patients with PSMA+ tumoursSecondary Objectives:• To characterise the serum PK of CB307• To characterise the immunogenic potential of CB307 and…
Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS) in the context of systemic juvenile idiopathic arthritis (sJIA) and adult onset Still*s disease (AOSD).• Cohort…
To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of low-medium tau pathology.
Objectives: Primary:• To evaluate the long-term safety and tolerability of AG-348Secondary:• To evaluate the long-term efficacy of AG-348• To evaluate the efficacy of AG-348 in increasing hemoglobin (Hb) concentrations in subjects who previously…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
Our primary objective is:i. To assess the quantity and regional distribution of [18F]DPA-714 binding as a marker of microglial activation in patients with FTD compared to controls. Our secondary objectives are: i. To compare the quantity and…
The objective of the study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult subjects with moderate to severe AD who are candidates for systemic therapy.
Primary objectives: To evaluate safety of ZED88082A in combination with CED88004S. To determine appropriate ZED88082A/CED88004S dosing and PET imaging time-points. To evaluate pharmacokinetics (PK) of ZED88082A/CED88004S in patients before and…
The objectives of this extension trial are to assess the long-term safety and maintenance of efficacy beyond 2 to 2.5 years of treatment with glepaglutide in adult patients with SBS.Primary Objective:To evaluate the long-term safety of glepaglutide…
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 objectives:The objective is to study the distribution of CD8+ T-cells before and after CAR T-cell therapy in the patient by ZED88082A/CED88004S-PET imaging. We will correlate the pretreatment CD8+ T-cell distribution and CD8+ CAR T-cell…
Primary: i) To determine the optimal 89Zr-DFO-REGN3767 protein dose and optimal PET imaging timepoint. ii) To evaluate the pharmacokinetics (PK) of 89Zr-DFO-REGN3767 by measuring standardized uptake value (SUV) on 89Zr-DFO-REGN3767 PET scans in…
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…
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…
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 (with or without LDSC-IL2)• To investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.• To determine the RP2D of LAVA-1207 in patients with therapy refractory mCRPC.…
To compare PFS of patients with progressive, advanced, kinase inhibitor naïve, RET-mutant MTC treated with selpercatinib versus cabozantinib or vandetanib.
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…