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Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma

This study has been transitioned to CTIS with ID 2024-516125-31-02 check the CTIS register for the current data. Primary objective is to determine safety and tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended…

Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO) (study 208467)

This study has been transitioned to CTIS with ID 2024-513032-14-00 check the CTIS register for the current data. Primary:To evaluate the efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02…

A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren*s Syndrome (TWINSS)

The purpose of this trial is to- determine the dose-response of iscalimab in a population of patients with moderate-to-severe Sjögren*s Syndrome (SjS), defined by ESSDAI >=5and ESSPRI >=5 (Cohort 1)- evaluate the preliminary efficacy…

A randomized, open-label, parallel group, two arm, proof-of-concept clinical trial to investigate the efficacy and safety of LNP023 compared with rituximab in the treatment of subjects with idiopathic membranous nephropathy.

The purpose of this study is to ascertain the efficacy, safety, tolerability and pharmacokineticsof LNP023 over a 24-week treatment period compared with rituximab in subjects with MN.

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of Rilzabrutinib (PRN1008), an Oral BTK Inhibitor, in Patients with Relapsed Immune Thrombocytopenia

This study has been transitioned to CTIS with ID 2023-509397-39-00 check the CTIS register for the current data. Part A: Safety:• To characterize the safety and tolerability of up to four dose levels of rilzabrutinibin patients with ITPEfficacy:• To…

A Phase 2b, Multicenter, Randomized, Open-label, Two-Arm Study to Evaluate the Clinical Efficacy and Safety of OHB-607 Compared to Standard Neonatal Care for the Prevention of Bronchopulmonary Dysplasia, the Most Common Cause of Chronic Lung Disease of Prematurity

This study has been transitioned to CTIS with ID 2024-515914-41-00 check the CTIS register for the current data. The primary objective of this study is to assess the effect of OHB-607 on reducing the burden of CLD, as indicated by a reduction in the…

A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The primary objective of the study is:• To evaluate the clinical efficacy of rozanolixizumab as a treatment for subjects with CIDPThe secondary objectives of the study are:• To evaluate the safety and tolerability of rozanolixizumab sc infusion in…

A Phase 2b dose-finding study for SAR442168, a Bruton's tyrosine kinase inhibitor, in participants with relapsing multiple sclerosis

Primary: - To determine the dose-response relationship for SAR442168 to reduce the number of new active brain lesions. Secondary: - To evaluate efficacy of SAR442168 on disease activity, assessed by clinical and imaging measures.- To evaluate the…

Short-term safety, efficacy and mode of action of apremilast in mild to moderate cutaneous pemphigoid: a phase IIa open label single arm study.

Primary Objective: To evaluate the achievement of partial remission by apremilast combined with doxycyclineat week sixteen (t=16). Secondary Objectives: • Complete remission at week sixteen; • Disease control at week six (t=6); • Drug survival;•…

Neo-adjuvant Pembrolizumab in dMMR/ POLE-EDM uterine cancer patients: a feasibility study

We aim to establish proof-of-concept for use of pembrolizumab as novel neo-adjuvant therapy in dMMR and POLE-EDM UC. When ICB proves to be feasible as defined in the primary endpoint (see 2.1), we will follow-up with larger studies to determine…

Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity

Main objective:To explore the impact of setmelanotide on obesity in patients with various specific rare genetic mutations.Secondary objective:To assess the effects of setmelanotide on:* Safety and tolerability-Hunger* Waist circumferenceOptional sub…

A Randomized, Double Blind, Placebo Controlled, Phase 2a Study to Assess the Clinical Efficacy of ISIS 721744, a Second Generation Ligand Conjugated Antisense Inhibitor of Prekallikrein, in Patients with Hereditary Angioedema

The primary objective of the study is to evaluate the clinical efficacy of antisense inhibitor of prekallikrein (ISIS 721744) in patients with hereditary angioedema (HAE) type 1 (HAE 1), HAE type 2 (HAE 2), or HAE with normal C1-inhibitor (C1-INH).…

Randomized, double blind, multicenter extension to CZPL389A2203 dose-ranging study to assess the shortterm and long-term safety and efficacy of oral ZPL389 with concomitant or intermittent use of TCS and/or TCI in adult patients with atopic dermatitis (ZEST Extension)

The purpose of this study is to assess short-term and the long-term safety and efficacy of oral ZPL389 (30 mg once daily (o.d.) and 50 mg o.d.) when used concomitantly or intermittently with topical corticosteroid (TCS) and/or topical calcineurin…

A Phase 2, single-arm study of bempegaldesleukin (NKTR-214) in combination with nivolumab in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients

The primary objective is:• To evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per…

A Randomized, Double-blind, Adaptive, Phase II/III Study of GSK3359609 or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (study 209229)

Primary: • Compare the efficacy of GSK3359609 in combination with pembrolizumab to pembrolizumab plus placebo in the PD-L1 expression positive (CPS >=1) population and in the PD-L1 expression high (CPS>=20) populationSecondary: •…

A randomized, open-label, phase I/II open platform study evaluating safety and efficacy of novel ruxolitinib combinations in myelofibrosis patients

To characterize the safety, tolerability, and recommended phase 2 dose (RP2D) of each combination partner used with ruxolitinib (Part 1)To evaluate the preliminary efficacy of each novel ruxolitinib combination treatment arm (Parts 2 & 3)

Sleep positional therapy for the treatment of nocturnal gastroesophageal reflux

The main objective of the study is to assess the effect of sleep positional therapy, using the LEFT device, on nocturnal gastroesophageal reflux.

A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma

This study has been transitioned to CTIS with ID 2023-506587-13-00 check the CTIS register for the current data. The safety and efficacy of JNJ-68284528 in heavily pretreated patients with multiple myeloma is being evaluated in the Phase 1b/2 Study…

A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementia

Primary ObjectivePart1: To evaluate the safety and tolerability of intravenous (IV) administration of AL001 over up to 96 weeks in asymptomatic and symptomatic carriersof a granulin (GRN) mutation causative of frontotemporal dementia (FTD) and in…

A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer

To evaluate PFS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by Durvalumab