St Maur Des Fosses, France

  • Featured

    Combination Therapies With Adagrasib in Patients With Advanced NSCLC With KRAS G12C Mutation

    Phase

    2

    Span

    227 weeks

    Sponsor

    Mirati Therapeutics Inc.

    Barcelona

    Recruiting

  • Featured

    Study to evaluate HZN-825 in patients with Idiopathic Pulmonary Fibrosis (IPF)

    This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in subjects with IPF. Subjects will be screened within 8 weeks prior to the Baseline (Day 1) Visit. Approximately 360 subjects who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks using the following 2 stratification factors: Prior use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no; FVC % predicted at Baseline: ≥70% or <70%.

    Phase

    2

    Span

    123 weeks

    Sponsor

    Horizon Therapeutics Ireland DAC

    L'Hospitalet De Llobregat

    Recruiting

  • Featured

    PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706

    This study is designed to assess the ability of K0706 to slow the progression of PD. Preclinical animal model data have already demonstrated that K0706 has neuroprotective activity, but further development will require human clinical experience. This study will also allow determination of safety and tolerability of K0706 over many months in subjects with PD.

    Phase

    2

    Span

    246 weeks

    Sponsor

    Sun Pharma Advanced Research Company Limited

    Barcelona, Spain

    Recruiting

  • Clinical Effectiveness and Bacteriological Eradication of 4 Short-course Antibiotics for Uncomplicated UTIs in Women.

    Uncomplicated lower urinary tract infections (LUTI) represent a common problem in primary care. Resistance of uropathogens to common antibiotics has significantly increased in the last years. Current local guidelines recommend the use of a single 3 g dose of fosfomycin for these infections, but most general practitioners prefer short-course therapies to single-dose therapy. No study has compared head-to-head short course antimicrobial agents for uncomplicated LUTIs. Therefore, the aim of this randomized clinical trial is to compare three different short-course antibiotic therapies with single-dose fosfomycin for uncomplicated LUTIs in adult women. This will be a pragmatic, multicenter, parallel group, open randomized trial. Women aged 18 or older and with symptoms of uncomplicated LUTI and a positive urine dipstick analysis will be randomized to one of the following four groups: 2-day 3 g fosfomycin o.d., 3-day pivmecillinam 400 mg. t.i.d, 5-day nitrofurantoin 100 mg t.i.d. or a single dose of 3 g of fosfomycin. Sample: 1,000 patients. Two co-primary endpoints are considered: clinical effectiveness, defined as resolution of symptoms, answered by the patients at day 7, and bacteriological eradication (proportion of patients bacteriologically cured) at day 14. Patients will be given a symptom diary for seven days. Follow-up visits are scheduled at days 7 (phone call), 14 and 28 for assessing evolution. Urine samples will be collected in the three on-site visits and urine cultures performed. If positive, antibiograms for the 3 antibiotics studied will be performed.

    Phase

    4

    Span

    165 weeks

    Sponsor

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    Sant Just Desvern, Catalonia

    Recruiting

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