Kfar-saba, Israel
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Study to evaluate HZN-825 in patients with Diffuse Cutaneous Systemic Sclerosis (dcSSc)
This is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial for HZN-825, a selective antagonist of lysophosphatidic acid receptor-1 (LPAR1). Participants will be screened within 4 weeks prior to the Baseline (Day 1) Visit. Approximately 300 participants who meet the trial eligibility criteria will be randomized on Day 1 in a 1:1:1 ratio to receive HZN-825 300 mg QD, HZN-825 300 mg BID or placebo for 52 weeks. Participants will take their first dose of trial drug at the clinic and will return to the clinic for trial visits at Week 4 and every 6 weeks thereafter until Week 52. Participants who complete the Double-blind Treatment Period (Week 52) may be eligible to enter a 52-week extension trial (HZNP- HZN-825-302). Participants not entering the extension will return to the clinic for a Safety Follow-up Visit 4 weeks after the last dose of trial drug.
Phase
2Span
139 weeksSponsor
Horizon Therapeutics Ireland DACKfar Sava
Recruiting
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.
Phase
3Span
331 weeksSponsor
AbbVieKefar Sava
Recruiting
Observational Evaluation of Atopic Dermatitis in Pediatric Patients
The study duration is 120 months.
Phase
N/ASpan
871 weeksSponsor
SanofiKefar Sava
Recruiting
Outcomes of Low-Risk Endometrial Cancer with Isolated Tumor Cells in the Sentinel Lymph Nodes: a Prospective, Multicenter, Cohort Study
PRIMARY OBJECTIVE: I. Evaluate whether patients with low-risk endometrial cancer and isolated tumor cells (ITC) will have worse recurrence-free survival (RFS) than a historical cohort of similar patients with negative nodes. OUTLINE: This is an observational study. Patients undergo tissue sample collection and have their medical records reviewed on study.
Phase
N/ASpan
256 weeksSponsor
Mayo ClinicKefar Sava
Recruiting
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Phase
3Span
151 weeksSponsor
SanofiKefar Sava
Recruiting