A multicenter international randomized placebo controlled double-blind parallel group and event driven Phase 3 study of the oral FXIa inhibitor asundexian (BAY 2433334) for the prevention of ischemic stroke in male and female participants aged 18 years and older after an acute non-cardioembolic ischemic stroke or high-risk TIA
OCEANIC-STROKE (study 20604) is a multicenter, international, randomized, placebocontrolled, double-blind, parallel group, event driven phase 3 study. The purpose of this study is to investigate the efficacy of the oral FXIa inhibitor asundexian in prevention of ischemic stroke and its safety (bleeding) compared with placebo on top of background antiplatelet therapy in adult participants after an acute non-cardioembolic ischemic stroke or high-risk TIA.
A Multicenter Interventional Post-marketing Randomized Double-blind Crossover Study to Evaluate the Clinical Safety and Efficacy of AbobotulinumtoxinA (Dysport ) in Comparison with OnabotulinumtoxinA (Botox ) when Treating Adults with Upper Limb Spasticity
The safety and efficacy of onabotulinumtoxinA (onaBoNT-A) and abobotulinumtoxinA(aboBoNT-A) have been investigated and demonstrated in phase III trials versus placebo. However, although both products achieved alleviation of clinical symptoms of spasticity compared to placebo, their safety/efficacy has never been compared in a blinded prospective study. There is currently a lack of any multicentre, randomised, double-blind study to compare the clinical safety and efficacy of aboBoNT-A and onaBoNT-A in adult spasticity. This comparative cross-over study will aim to demonstrate the non-inferiority of aboBoNT-A versus onaBoNT-A as a primary safety endpoint, and the superiority of aboBoNT-A over onaBoNTA with respect to duration of response as the key secondary efficacy endpoint, when used at optimal doses of each product. It will provide robust evidence from the clinical setting to allow informed therapeutic decisions for care optimisation, including use of the optimal dose according to the approved product label (prescribing information).
A Multicenter Open-Label Study of RMC-6236 in Patients with Advanced Solid Tumors Harboring Specific Mutations in RAS
A Multicenter Open-Label Study of RMC-6236 inPatients with Advanced Solid Tumors Harboring Specific Mutations in RAS
A Multicenter Randomized Double-Blind Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn s Disease
This is a seamless Phase 2/3, multicenter, randomized, double-blind, study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of etrasimod as therapy in subjects with moderately to severely active CD who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). Subjects who are refractory or intolerant to corticosteroids and/or immunosuppressants may be either previously exposed to or naïve to biologics.
A Multicenter Randomized Double-Blind Placebo-Controlled Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients with Systemic Lupus Erythematosus
This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the HZ/su vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. We hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, we hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.
A Multicenter Randomized Double-blind Placebo-controlled Phase 3 Study Evaluating the Efficacy and Safety of Subcutaneous Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus
This is a Phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of an SC treatment regimen of anifrolumab versus placebo in adult patients with moderately-to-severely active, autoantibody-positive SLE despite receiving SOC. Subjects must be receiving stable SOC prior to Screening consisting of any of the following: OCS monotherapy, OCS plus antimalarials and/or immunosuppressants (azathioprine, antimalarials, mycophenolate mofetil / mycophenolic acid, methotrexate, or mizoribine); or immunosuppressants with or without OCS; please refer to the Section X- Inclusion Criteria for more detail.Approximately 360 subjects will be randomized in a 1:1 ratio to receive a fixed SC dose of anifrolumab (120 mg) or placebo QW with the primary endpoint evaluated at Week 52. Investigational product (IP) will be administered SC via an aPFS. All patients with a baseline prednisone (or equivalent) dose of = 10.0 mg/day must attempt tapering of their baseline dose to = 7.5 mg/day. Tapering will start at Week 8 and continue through Week 40, unless there are signs of increased disease activity. This study includes:• A screening period of up to 30 days • A 52-week double-blind treatment period with a total of 52 anifrolumab or placebo doses• A 10-week safety follow-up after last IP dose
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence with Inflammatory Bowel DiSease Therapy ASSIST Study
The proposed study is a multicenter, randomized, controlled, clinical trial to be conducted over 12 months. Participants in the intervention arm will verify medication adherence using the Tappt web-based system. Additionally, they will complete a two-item assessment of symptoms monthly. Participants randomized to the control group will receive standard care. All participants are required to complete questionnaires at baseline, 12 weeks, 26 weeks, and 52 weeks.
A Phase 1 and 2a open-label trial to evaluate the safety tolerability pharmacokinetics pharmacodynamics immunogenicity and antitumor activity of LAVA-1207 a PSMA-targeting bispecific .d-T cell engager alone or with low dose interleukin-2 or Pembrolizumab in patients with therapy refractory metastatic castration resistant prostate cancer
This trial is an open-label, multi-center, Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary antitumor activity of LAVA-1207 in patients with therapy refractory mCRPC. The trial starts with an open-label, dose-escalation part (Part 1) to determine the recommended Phase 2 dose (RP2D). The second part of the trial (Part 2) is an open-label expansion cohort at the RP2D and schedule, in which the number of patients will be expanded to confirm safety in a patient population with therapy refractory mCRPC with measurable disease.
A PHASE 1 FIRST IN HUMAN DOSE ESCALATION AND EXPANSION MULTICENTER STUDY OF XMT- 2056 IN PARTICIPANTS WITH ADVANCED/RECURRENT SOLID TUMORS THAT EXPRESS HER2
The proposed first-in-human study of XMT-2056 will be a Phase 1, open-label study of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2. The XMT-2056 monotherapy trial will consist of dose escalation (DES) and expansion (EXP) parts.DES will be the dose-finding proportion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D). TheRP2D will be determined based on the totality of the clinical data, including safety and preliminary anti-tumor effect, PK, and relevant biomarker data.Upon determination of the RP2D observed in monotherapy, XMT-2056 in combination with otherapproved agent(s) may be explored (see Section 2.4.2 and Section 4.1.2) and will be specified in afuture amendment.
A Phase 1 First in human Dose Escalation and Expansion Multicenter Study of XMT-1660 in Participants with Solid Tumors
The proposed first-in-human study of XMT-1660 will be a Phase 1, open-label trial of XMT-1660 in previously treated participants with metastatic TNBC, HR+/HER2- or HER2+ breast cancer, endometrial cancer, or ovarian, fallopian tube, or primary peritoneal cancer. The study is composed of 2 parts: a dose escalation part (DES) and an expansion (EXP) part. The DES part of the study will be the dose finding cohort to assess tolerability and safety of XMT-1660 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). The EXP part of the study will further evaluate the preliminary efficacy and safety of XMT-1660 at the MTD and/or RP2D in participants with advanced/metastatic (1) TNBC; (2) HR+/HER2- breast cancer; and (3) endometrial or ovarian, fallopian tube, or primary peritoneal cancer.