29 results
PrimaryTo assess the extended overall response rates of orally administered TKI258, at 500 mg/day, on a five days on and two days off dosing schedule, in groups of patients with relapsed or refractory multiple myeloma who are* with t(4;14)…
Primary objectivesTo evaluate the effect of the CYP1A2 inhibitor, fluvoxamine, on steady state pharmacokinetics of TKI258 in patients with advanced solid tumors, excluding breast cancerSecondary objectives• To characterize the safety and…
To assess the efect of IL-17 blockade on:- the global synovial histology and inflammatory infiltration- the number and type of IL-17 producing cells in SpA synovitis- the productuion of inflammatory mediators (including other IL-17 related cytokines…
Primary: To demonstrate the superiority of secukinumab in subjects with moderate to severe plaque psoriasis based on the proportion of PASI 90 responders at Week 16, compared to ustekinumab.Secondary: To demonstrate the superiority of secukinumab in…
To collect long term data on safety and tolerability of dovitinib monotherapy.
To evaluate the effects of mild, moderate or severe hepatic impairment versus normal hepatic function on the pharmacokinetics of TKI258 in patients with advanced solid tumor
Primary objectives* To determine the Overall Response Rate (ORR) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258* To determine the Overall Response Rate (ORR) in patients with (FGFR3WT) advanced urothelial carcinoma…
Primary: To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNFα inhibitor naïve.…
The purpose of this study is to compare the safety and efficacy of secukinumab monotherapy and adalimumab monotherapy in patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy for PsA or PsO and are intolerant or having…
This study is designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response.Secondary (key only): ASAS responses in the…
The objective of this study is to evaluate the efficacy and safety of risankizumab compared with secukinumab for the treatment of adult subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy.
This study will assess if a more prolonged dose interval (every 6 weeks compared to every 4 weeks) will allow psoriasis patients who achieveclear or almost clear skin after 24 weeks of secukinumab treatment - Psoriasis Area and Severity Index (PASI…
The purpose of this study is to determine whether early intervention with subcutaneous (s.c.) secukinumab 300 mg in patients with new-onset moderate to severe psoriasis may lead to prolonged symptom-free periods by preventing reactivation of old…
Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…
The purpose of the study is to investigate the use of secukinumab (AIN457) treat ment in children from 2 to18 years of age with either active Enthesitis -Related Arthritis (ERA) or Juvenile Psoriatic Arthritis (JPsA) subtypes of Juvenile Idiopathic…
Main Objective:To demonstrate the efficacy of secukinumab compared to placebo withrespect to HiSCR after 16 weeks of treatment.Secondary objective:To demonstrate the efficacy of secukinumab compared to placebo after 16 weeks of treatment with…
Primary: To demonstrate that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving ACR20 response in subjects with active PsA.Secondary:- PASI75 week 24- PASI90 week 24-…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response.Secondary (key only): ASAS40 week 16 response in…
Primary: To demonstrate the efficacy of one or both secukinumab regimens at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNF*…