17 results
To assess arterial wall inflammation, measured with 18F-FDG PET/CT scan, in patients with intermediate and severe FH phenotype, as well as the change in arterial wall inflammation following PCSK9 inhibition.
The primary objectives of this add-on Phase 2 LTE study (see Table 1) are to evaluate the long-term safety and tolerability of IMP at three possible doses (ie, 15 mg/kg, 40 mg/kg, and 60 mg/kg) and to assess the effect of dose titration on the…
To assess the efficacy of venetoclax in combination with AZA compared to placebo with AZA in treatment-naive higher-risk MDS.
The primary objective: - Evaluate efficacy of ibrutinib + venetoclax (VI) in terms of proportion of patients fulfilling the criteria for progression free survival (PFS) at 12 months after stopping therapy (27 months after starting treatment) for…
The objective of the study is to assess the efficacy and safety of Alirocumab in patients with heterozygote familial hypercholesterolemia whose LDL-C level is higher than or equal to 160 mg/dL (4.14 mmol/L) on maximally tolerated statin therapy with…
Primary objective* To assess the long-term safety of alirocumab when added to currently available lipid-modifying drug therapy in patients with heterozygous familial hypercholesterolemia (heFH) who have completed one of the following studies:…
In the present study, we set out to evaluate arterial wall inflammation in patients at increased CV-risk with statin-associated muscle symptoms (SAMS), precluding effective statin therapy. Following twelve weeks of treatment with PCSK9-Ab, the…
The primary objective of the study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients…
Primary objective• To evaluate efficacy of acalabrutinib/venetoclax (AV) in terms of undetectable minimal residual disease (uMRD) response in bone marrow (BM) after 26 cycles of treatment in patients with CLL previously treated with venetoclax and…
Primary objective- To evaluate the efficacy of 6 cycles ibrutinib/obinutuzumab in converting patients who are not in CR or who have detectable MRD on combination ibrutinib and venetoclax in uMRD (BM) CR Secondary objectives- To explore the kinetics…
Primary objective: To determine the efficacy of the combination of acalabrutinib and venetoclax without obinutuzumab (AV; Arm A), or with obinutuzumab (AVG; Arm B) compared with chemoimmunotherapy (fludarabine/cyclophosphamide/rituximab [FCR]/…
The main objectives of the trial are to:• evaluate the safety of venetoclax monotherapy.• determine dose limiting toxicities (DLT) and the recommended Phase 2 dose (RPTD) of venetoclax monotherapy.• assess the pharmacokinetics (PK) of venetoclax…
To assess if venetoclax combined with FLA+GO (fludarabine, high-dose cytarabine, and gemtuzumab ozogamicin) will improve overall survival of children with relapsed acute myeloid leukemia (AML) compared to FLA+GO .
The aim is thereby to reduce the risk of serious infections and the need for regular CLL treatment.
The primary objective of the study is to evaluate the safety, tolerability, PK, and PD of AL002 administered in single ascending doses in healthy participants and multiple doses in participants with mild to moderate AD.
Primary ObjectiveThe primary objective of the study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review…
To evaluate the efficacy of AL002 in participants with Early AD in delaying disease progression compared to standard of care