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RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19

• To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19• To show that ATR-002 in addition to standard of care shortens the time to…

A Phase 2, Randomized Placebo-Controlled, Double-Masked Study to Assess Safety and Efficacy of Multiple doses of IONIS-FB-LRX, an Antisense Inhibitor of Complement Factor B, in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

To evaluate the effect of ISIS 696844 on the rate of change of the area of GA secondary to AMD measured by fundus autofluorescence (FAF)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

To assess the safety, tolerability, and efficacy of ABBV-154 administered every other week (eow) and every 4 weeks (e4w) subcutaneously (SC) vs placebo in subjects with moderately to severely active RA with inadequate response to at least one prior…

A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,
group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the
treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…

A Phase 2a Study of TPN-101 in Patients with C9ORF72 ALS/FTD (Amyotrophic Lateral Sclerosis and/or Frontotemporal Dementia)

The primary objective of this study is:* To assess the safety and tolerability of TPN-101 in patients with C9ORF72 ALS/FTDThe exploratory objectives of this study are:* To assess the concentrations of TPN-101 in plasma and cerebrospinal fluid (CSF…

A PHASE II, RANDOMISED, ADAPTIVE, OPEN-LABEL
PLATFORM TRIAL TO EVALUATE EFFICACY AND
SAFETY OF MULTIPLE COMBINATION THERAPIES IN
PARTICIPANTS WITH CHRONIC HEPATITIS B

Primary* To estimate the effect of NME combination therapies on inducing a functional cure over the control arm.Secondary * To characterize the efficacy profile of NME combination therapies.* To characterize the PD profile of NME combination…

A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas

Primary objectives:• Evaluate organ absorbed radiation doses from PRRT with Lutathera in adolescent patients with SSTR-positive GEP-NETs• Evaluate safety and tolerability of Lutathera in adolescents with SSTR-positive GEP-NETsSecondary objectives:•…

Phase 1/2 Study to Investigate the Safety, Pharmacokinetics and Efficacy of Tinostamustine, a First-in-Class Alkylating Histone Deacetylase Inhibition (HDACi) Fusion Molecule, in Patients with Advanced Solid Tumors

The ability to fuse discrete small molecules with different types of pharmacologic activity has created remarkable opportunities in drug discovery and development. Bendamustine itself is a fusion molecule of the nitrogen mustard mechlorethamine and…

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…

A Two-Cohort Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…

A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined with Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients with Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma with PD-L1 Expressing Tumors (PROPEL-36)

In patients who are aged 18 years and older with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC)and positive programmed cell death ligand1 (PD-L1)expression (defined by combined positive score [CPS]*1) who have not received…

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…

A Phase II Trial of Personalized Tumor Neoantigen Based Vaccine FRAME-001 for Advanced Non-Small Cell Lung Cancer

To determine FRAME-001-specific immune responses in peripheral blood after administration of FRAME-001 to patients with advanced NSCLC.Secondary objectives- To assess safety and tolerability of FRAME-001.- To evaluate clinical anti-tumor response to…

Randomized, double blind, mutlicenter, multinational, placebo controlled, single parallel escalating dose safety and efficacy study of ACT017 used as an add-on therapy on top of standard of care of acute ischemic stroke

The study primary objective will consist of assessing the safety and tolerability of single IV (bolus + infusion) doses of glenzocimab in patients with an acute ischemic stroke administered on top of the best emergency standard of care (including…

A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS)

The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren*s syndrome (pSS) versus placebo.

A Phase 2, Multicenter, Open-label Study of Sotorasib (AMG 510) in Subjects with Stage IV NSCLC Whose Tumors Harbor a KRASG12C Mutation in Need of First-Line Treatment (CodeBreaK 201)

Primary- To evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in subjects who receive sotorasib at either 960 mg daily (QD) or 240 mg QD whose tumors are PD-L1 Tumor…

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with hSCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Main objective: To assess the efficacy of NBI-921352 as adjunctive therapy on the frequency of countable motor seizuresSecondary Objectives • To evaluate the efficacy of NBI-921352 using the Clinical and Parent/Caregiver Global Impression of Change…

A study to investigate the effects of repeated low doses of psilocybin and ketamine on cognitive and emotional dysfunctions in Parkinson*s disease and to understand its mechanism of action

The primary objective is to investigate the effects of repeated small doses of psilocybin and ketamine on affect (self-rated). Secondary objectives are to is to investigate the effects of repeated small doses of psilocybin and ketamine on [1] well-…

A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers

Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…

A Phase 2a, Open-label, Multicenter Study to Evaluate Biomarkers and Safety of Repeated Administration of NurOwn® (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors; MSC-NTF cells) in Participants with Prodromal to Mild Alzheimer*s Disease

Primary:• To evaluate AD-specific, neuroinflammatory, neurotrophic and neurodegenerative biomarkers and safety of 3 intrathecal (IT) administrations of NurOwn® (MSC-NTF cells) given at two monthly intervals to participants with prodromal to mild…