117 results
Primary objective - To assess the efficacy of q4w x3 i.a. injections of LRX712 in restoring the morphometrics of articular cartilage in the medial femoral condyleSecondary objectives- To evaluate LRX712 and metabolite MAE344 pharmacokinetics in…
Primary Objectives1) To compare the Progression Free Survival (PFS) per RECIST 1.1 as assessed by blinded independent central review (BICR) in first line recurrent / metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) subjects, treated…
x To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD x To compare the annual rate of change from Baseline in forced vital capacity (FVC), in mL, of MK-7240/PRA023 vs. placebo over 50 weeks For more information please refer to…
Primary objective* To assess the efficacy of EP547 compared to placebo on pruritus as assessed by the Worst Itch Numeric Rating Scale (WI-NRS)Secondary* To assess the efficacy of EP547 compared to placebo on the following:* Pruritus-related quality…
The primary objective is to determine the safety, tolerability, dose-limiting toxicities (DLTs), and maximum tolerated dose (MTD) of BMS-986016 administered alone and in combination with nivolumab in subjects with advanced solid tumors.The co-…
To evaluate the effects of IV administration of GSK3858279 in Ultraviolet B (UVB) burn inflammatory, cold pressor test and electrical pain test in the PainCart
* To assess safety and tolerability of single oral doses of NMD670 in healthy male and female subjects * To assess safety and tolerability of repeated oral doses of NMD670 in healthy male subjects * To assess safety and tolerability of single oral…
Primary objectivePhase I: To determine the recommended phase II dose (RP2D) of the combination treatment with nivolumab and entinostat administered to adolescents 12-21 years with progressive, relapsed , refractory high-risk solid tumors and CNS…
To investigate the safety and tolerability, and to characterise the pharmacokinetics (PK) of RGH-338 in healthy subjects
Primary objectivesThis Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis and consists of 2 sequential periods - an initial double-blind placebo-controlled period of minimum 72 weeks followed by a double-blind…
Primary objective: To evaluate the efficacy of inebilizumab in reducing the risk of a disease flare in patients with IgG4-RD.Secondary objectives:• To evaluate the safety and tolerability of inebilizumab in patients with IgG4-RD.• To evaluate the…
To assess the effect of MEDI4736 in combination with olaparib±bevacizumab in patients with selected advanced solid tumors.To assess the safety and tolerability of MEDI4736 in combination with olaparib (±bevacizumab) in patients with selected…
Dose Escalation (GEN3009 for R/R B-cell NHL Including CLL/SLL):- Determine the MTD with and/or determine the RP2D of GEN3009- Evaluate safety and tolerability of GEN3009Expansion (GEN3009 for R/R, DLBCL, FL, and CLL Cohorts):-Evaluate (preliminary)…
Primary• To investigate the safety and tolerability of multiple oral doses of DNL343 in participants with ALSSecondary• To characterize the PK of DNL343 in plasma following single and multiple oral doses• To characterize the concentration of DNL343…
Objectives Part A: • To evaluate the safety and tolerability of CIT-013 after administration of single, ascending, IV doses in healthy volunteers.• To evaluate the pharmacokinetics of CIT-013 after administration of single, ascending, IV doses in…
To compare the 120 mg once daily (QD) dose and 200 mg QD dose of MK*6482with respect to objective response rate (ORR) based on Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
The objectives of this follow-up study of the EPITOPE study are:• To assess the clinical benefit of Viaskin Peanut after up to 3 years of epicutaneous immunotherapy (EPIT) to induce/maintain desensitization to peanut in peanut-allergic children;• To…