Multiple Locations, Australia
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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 TherapeuticsMadrid, Spain
Recruiting
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A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of INCMGA00012 (formerly MGA012) in Patients with Advanced Solid Tumors
Study is fully recruited except for MSI high or dMMR endometrial cancer
Phase
1Span
Sponsor
Madrid
Recruiting
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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 DACMadrid
Recruiting
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Madrid
Recruiting
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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
Madrid, Madrid
Recruiting
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Madrid, Madrid
Recruiting
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Efficacy, Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of BIA 28-6156 in GBA-PD
This is a 2-part (Part A [Genetic Screening] and Part B [Double-Blind Treatment]), Phase 2, multicenter, randomized, double-blind, placebo- controlled study evaluating the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics of 2 fixed dose levels of BIA 28-6156 (10 and 60 mg/day) in approximately 237 subjects with genetically confirmed GBA-PD. Part A (Genetic Screening) is identifying individuals with a PD risk- associated variant in the GBA1 gene for potential enrolment into Part B (Double-Blind Treatment) of the study. Part B consists of a screening period to ensure that all protocol inclusion/exclusion criteria for Part B of the study are met (up to 5 weeks). After screening period, eligible subjects are randomized into 1 of 3 treatment arms (BIA 28-6156 10 mg/day, BIA 28-6156 60 mg/day, or placebo) in a 1:1:1 ratio, and enter a double-blind treatment period up to 78 weeks, followed by a 30-day (4 weeks) of safety follow-up period. Subjects must be receiving a stable dose of PD medication for at least 30 days before screening (for Part B [Double-Blind Treatment]) and continue to receive their usual PD medications throughout the study.
Phase
2Span
157 weeksSponsor
Bial R&D Investments, S.A.Madrid
Recruiting
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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
2Span
246 weeksSponsor
Sun Pharma Advanced Research Company LimitedMadrid
Recruiting