18 results
Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…
1. To evaluate efficacy of vorinostat in the treatment of patients with polycythaemia vera (PV) and essential thrombocythaemia (ET) 2. To evaluate if vorinostat as monotherapy of patients with PV and ET is followed by a decline in clonal…
Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…
Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…
Primary objectivesTo confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs. placebo significantly increases trough FEV1 (defined as mean evaluation at 23 h 15 min and 23 h 45 min post dose) following 12 weeks of treatment in patients with…
The main purpose of this study is to determine if KW-0761, an investigational drug will work against cutaneous T-cell lymphoma (CTCL) that has failed to respond to other treatments, and to evaluate its side effects. An investigational drug is one…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
The primary objective of this study is:* To evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the proportion of subjects achieving an American College of…
The purpose of this study is to see how filgotinib, the experimental drug, affects male sperm and to see if it is a safe and effective treatment for men with moderately to severely active inlammatory bowel disease.
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of remission in subjects with moderately to severely active Ulcerative Colitis (UC). Subjects who are biologic-naïve and…
The primary aim of this proof of principle (POP) and pharmacological study is to demonstrate significant anti-tumor activity of vorinostat in advanced resistant BRAF V600 melanoma and secondary aims are to explore the safety, pharmacokinetics and…
The primary objective of this study is:* To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA.The secondary objectives of this study are:* To evaluate the long-…
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in
Subjects with Ulcerative Colitis
The primary objective of this study is:* To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-Sponsored filgotinib treatment study in UCThe…
To investigate the effect of filgotinib on phenotype, B cell receptor (BCR) usage and functional parameters of circulating B cells expressing ACPA in patients with ACPA-positive RA that show incomplete response to standard, medium-dose methotrexate…
The primary objective of this study is:* To evaluate the effect of filgotinib compared to placebo in active psoriatic arthritis (PsA) as assessed by the American College of Rheumatology 20% improvement (ACR20) response at Week 12Secondary objectives…
We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to glucocorticoids and JAK inhibitors. Therefore, the aims of this randomized controlled trial are: 1. To compare…
The primary objective of this study is:- To observe the long-term safety of filgotinib in subjects who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CDThe secondary objective of…
The overall objective of the study is to evaluate the effect of treatment with filgotinib on the induction and maintenance of clinical remission, as well as , endoscopic response in subjects with moderately to severely active Crohn's disease (…