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  • Efficacy and Safety of KBP-336 in Obese Individuals with Osteoarthritis

    Phase

    2

    Span

    101 weeks

    Sponsor

    KeyBioscience AG

    Wroclaw

    Recruiting

  • A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older

    Phase

    3

    Span

    58 weeks

    Sponsor

    GlaxoSmithKline

    Wroclaw

    Recruiting

    Healthy Volunteers

  • A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis

    Phase

    3

    Span

    148 weeks

    Sponsor

    Amgen

    Wroclaw

    Recruiting

  • Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock

    The prospective registry will be open in nature; any cardiology department in Poland with access to a 24-hour hemodynamic laboratory will be eligible to participate in the study. All participants will use an electronic CRF (Case Report Form) to anonymously collect data on the incidence, etiology, diagnosis, treatment approaches, and prognosis of patients with cardiogenic shock. Data will be collected by researchers from the medical documentation of participating centers. The data collection period will span six months, followed by a six-month prospective observation through visit in person, per telephone contact to the patient or his/her relatives or by retracting National Health Fund data in case the contact to the patient or his/her relatives is impossible. To enable comparison with global data, collected information will include, among other aspects, the latest Society for Cardiovascular Angiography and Interventions (SCAI) classification for cardiogenic shock, the availability and application of modern short- and long-term mechanical circulatory support techniques, and the frequency of heart transplants.

    Phase

    N/A

    Span

    92 weeks

    Sponsor

    Wroclaw Medical University

    Wroclaw

    Recruiting

  • A Study to Compare Efficacy, Pharmacokinetics, Safety and Immunogenicity of MB04 [proposed Etanercept Biosimilar] to Enbrel® [EU-sourced] in Rheumatoid Arthritis

    The study will randomize approximately 458 patients aged between 18 and 75 years with active Rheumatoid Arthritis despite methotrexate therapy. All patients shall receive methotrexate for ≥12 weeks and on a stable dose (10 to 25 mg/week) for ≥8 weeks prior to randomization, and folic acid (≥5 mg/week) from 4 weeks prior to screening until the end of the treatment period (Week 36). Screening evaluations will be completed within 28 days prior to randomization. There will be 2 periods in the study: Main Treatment period and Transition period. During the Main Treatment Period, eligible patients will be randomized, at a 1:1 ratio, to administer a 50 mg weekly dose of MB04 or EU- sourced Enbrel® subcutaneously (SC) using an Interactive Response System (IRT). After completing Week 24 assessment, patients will continue to receive the study treatment up to Week 36. Those patients who were originally assigned to EU-sourced Enbrel® will be randomized, at a 1:1 ratio, to receive either MB04 or EU-sourced Enbrel® SC, while patients originally assigned to MB04 will continue with the same treatment until Week 36. After treatment discontinuation, patients will undergo a Safety follow-up period for 4 weeks, up to week 40.

    Phase

    3

    Span

    70 weeks

    Sponsor

    mAbxience Research S.L.

    Wroclaw

    Recruiting

  • A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001

    Phase

    3

    Span

    97 weeks

    Sponsor

    Alumis Inc

    Wroclaw

    Recruiting

  • A 104-Week Study of Ritlecitinib Oral Capsules in Adults With Nonsegmental Vitiligo (Active and Stable) Tranquillo 2

    Study B7981080 is a Phase 3 randomized, double-blind, multicenter study with a 52-week placebo-controlled period (Part Ia) followed by a double-blind 52-week extension period (Part Ib) that includes randomized dose-up/down titration and a de novo 52-week non-randomized open-label cohort (Part II), investigating the efficacy, safety, and tolerability of ritlecitinib 100 mg QD and 50 mg QD compared with placebo in adult participants with nonsegmental active or stable vitiligo

    Phase

    3

    Span

    192 weeks

    Sponsor

    Pfizer

    Wroclaw, Dolnośląskie

    Recruiting

  • A Phase 3 Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria

    This is a global, multicenter, randomized, double-blind, parallel group, placebo-controlled phase 3 study investigating the efficacy, safety and tolerability of barzolvolimab in adult participants with Chronic Spontaneous Urticaria (CSU) who are symptomatic despite treatment with non-sedating second generation H1-antihistamines at 1-4 times the locally approved dose. There is a screening period of up to 4 weeks, followed by a 24-week placebo-controlled treatment period, a 28-week active treatment period where all participants receive barzolvolimab followed by a 16-week treatment free period. Approximately 915 adult participants (610 in the active arms and 305 in the placebo arm) will be randomly assigned to the treatment arms.

    Phase

    3

    Span

    147 weeks

    Sponsor

    Celldex Therapeutics

    Wroclaw

    Recruiting

  • A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

    Phase

    2

    Span

    109 weeks

    Sponsor

    H. Lundbeck A/S

    Wroclaw

    Recruiting

  • A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

    Phase

    3

    Span

    149 weeks

    Sponsor

    Eli Lilly and Company

    Wroclaw

    Recruiting

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