- Featured
A Randomized Phase 3 Study of Sitravatinib in Combination with Nivolumab Versus Docetaxel in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer with Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy (SAPPHIRE)
Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET. Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response. RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy. Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.
Phase
3Span
Sponsor
Ramat Gan
Recruiting
- Featured
Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)
The purpose of this study is to provide continued use of parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib to participants who are currently enrolled in an Incyte-sponsored study and receiving the same treatment, who have at least stable disease, who are obtaining clinical benefit (in the opinion of the investigator) on the current study treatment, as defined by the parent Protocol, and who are unable to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib outside a clinical study. Participants will continue on the same dose and schedule as the ones being administered in the Incyte- sponsored parent Protocol at the time of the rollover. The study will collect and assess safety information with regards to AEs.
Phase
2Span
217 weeksSponsor
Incyte CorporationTel Hashomer
Recruiting
- Featured
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 DACTel Hashomer
Recruiting
- Featured
TemPo Studies
**All eligible study participants will receive at no cost:** • Study-related consultation and care • Study visits, tests, assessments, and procedures • Study drugs (investigational drug or placebo)
Phase
N/ASpan
212 weeksSponsor
Cerevel TherapeuticsRamat Gan
Recruiting
Screening for Islet Autoantibodies in the Israeli Paediatric General Population for Detection of Pre-symptomatic Type-1 Diabetes Mellitus
Phase
N/ASpan
313 weeksSponsor
Rabin Medical CenterOr Yehuda
Recruiting
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Phase
2Span
223 weeksSponsor
Mirum Pharmaceuticals, Inc.Ramat Gan
Recruiting
A Phase 2 Study to Evaluate DNTH103 in Adults with Generalized Myasthenia Gravis (MAGIC)
The study includes the following periods: - Screening (up to 10 weeks) - Randomized, blinded, controlled treatment (RCT) period (13 weeks) - Open-label extension (OLE) period (optional) for eligible participants (52 weeks) - Safety follow-up (40 weeks)
Phase
2Span
201 weeksSponsor
Dianthus TherapeuticsRamat Gan
Recruiting
Ramat Gan
Recruiting
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor
Phase
3Span
122 weeksSponsor
SanofiRamat Gan
Recruiting
A Study of BND-35 in Participants With Advanced Solid Tumors
Estimated Study Duration: Dose Escalation (Part 1): Approximately 34 months. Dose Optimization/Expansion (Part 2): Approximately 24 months.
Phase
1Span
183 weeksSponsor
Biond BiologicsRamat Gan
Recruiting