Search for a trial

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 MULTICENTER, PHASE 2A, RANDOMIZED,
INVESTIGATOR-BLIND, SUBJECT-BLIND, PARALLEL-GROUP
STUDY TO EVALUATE THE EFFICACY AND SAFETY OF
BIMEKIZUMAB AND CERTOLIZUMAB PEGOL IN SUBJECTS
WITH ACTIVE ANKYLOSING SPONDYLITIS

3.1 Primary objectiveThe primary objective of the study is to evaluate the efficacy of bimekizumab administered scQ2W for 12 weeks compared to CZP in the treatment of subjects with active AS.3.2 Secondary objectivesThe secondary objectives of the…

A multi-centre, randomized, double-blind (sponsor open), placebocontrolled, repeat-dose, proof of mechanism study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and explore efficacy of GSK2330811 in participants with diffuse cutaneous systemic sclerosis (study 201247)

Primary:To evaluate the safety and tolerability of repeat subcutaneous doses of GSK2330811 in participants with dcSSc.Secondary:PK. PD (serum levels of total and free OSM). Antibodies against GSK2330811.

A Phase II, randomized, multi-center, placebo-controlled, double-blind study to investigate the safety of GS-248, and efficacy on Raynaud*s phenomenon (RP) and peripheral vascular blood flow, in subjects with systemic sclerosis (SSc)

Primary:To determine the safety and efficacy of GS-248 versus placebo on RP in subjects with SSc.Secondary:To determine the efficacy of GS-248 on peripheral vascular blood flow in subjects with SSc and RP.Exploratory:• To explore the…

[18F]fluor-PEG-folate PET/CT imaging in Giant Cell Arteritis.

Primary Objective: to evaluate arterial [18F]fluor-PEG-folate uptake on PET/CT in patients with active, large vessel GCA; and in the same patients after 9 months of standard treatment.Secondary objectives are:- Assessment of the relationship between…

[18F]PEG-Folate PET-CT imaging for monitoring of therapy response in Rheumatoid Arthritis patients

This study has been transitioned to CTIS with ID 2024-513537-21-00 check the CTIS register for the current data. To investigate the association between quantitative changes in whole body F-18-PEG Folate PET/CT (Folate PET) after 4 weeks and clinical…

A Phase 2, randomized, double-blind, placebo-controlled, multicenter proof-of-concept study evaluating efficacy and safety of rilzabrutinib (SAR444671) in adult patients with moderate-to-severe atopic dermatitis who are inadequate responders or intolerant to topical corticosteroids

Primary objective:Assess the efficacy of rilzabrutinib in participants with atopic dermatitis (AD)Secondary objectives: * Assess the efficacy of rilzabrutinib at different time points* Assess the safety of rilzabrutinib

A two-cohort, open-label, single arm, multicenter study to evaluate efficacy, safety and
tolerability, pharmacokinetics and pharmacodynamics, of emapalumab in children and
adults with macrophage activation syndrome (MAS) in Still*s disease (including systemic
juvenile idiopathic arthritis and Adult onset Still*s disease) or with MAS in Systemic lupus
erythematous

This study has been transitioned to CTIS with ID 2024-516153-52-00 check the CTIS register for the current data. Primary objective: To demonstrate efficacy of emapalumab in the treatment of patients in:• Cohort 1: Macrophage activation syndrome (MAS…

A MULTIPART EXPLORATORY STUDY TO EVALUATE SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

The Galvani Splenic Neuromodulation System consists of a lead, rechargeable implantable pulse generator, external components and accessories. The system is designed to deliver electrical stimulation to the splenic NVB in patients with moderate to…

A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis

This study has been transitioned to CTIS with ID 2024-511115-25-00 check the CTIS register for the current data. Primary Objective:The primary objective of this study is:• To evaluate the efficacy of namilumab in subjects with chronic pulmonary…

A randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 study of rilzabrutinib followed by an open-label extension phase in patients with moderate-to-severe chronic spontaneous urticaria (CSU) who remain symptomatic despite the use of H1 antihistamine treatment

The purpose of the study is to evaluate how effective rilzabrutinib is and how safe it is, in reducing the signs and symptoms in patients with chronic spontaneous urticaria (CSU), who continue to have symptoms despite the use of H1-antihistamines (…

A pilot, open-label, single arm, multicenter study to evaluate safety, tolerability, pharmacokinetics and efficacy of intravenous administrations of emapalumab, an anti-interferon gamma (anti-IFNγ) monoclonal antibody, in patients with systemic Juvenile Idiopathic Arthritis (sJIA) or Adult-onset Still*s Disease (AOSD) developing Macrophage Activation Syndrome/ secondary HLH (MAS/sHLH)

The aim of this study is to investigate how safe, effective, and well-tolerated multiple infusions of the experimental study treatment, emapalumab (the study medication) are in controlling this disease, as well as to check the concentrations of…

A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)

The primary objective is to characterize the PK profile of belimumab 200 mg SC in pediatric SLE participants.The secondary objectives are to evaluate the safety and tolerability of belimumab 200 mg SC in pediatric SLE participants and to…

Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double blind, Placebo controlled Study with a Long-term Open-label Extension

This study has been transitioned to CTIS with ID 2023-505321-14-00 check the CTIS register for the current data. Primary Objective:Efficacy of nipocalimab in participants with warm autoimmune hemolytic anemia (wAIHA)The key secondary objectives of…

A SINGLE ARM PILOT STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF SPLENIC NERVE STIMULATION IN PATIENTS WITH RHEUMATOID ARTHRITIS USING AN ACTIVE IMPLANTABLE DEVICE

Study GAL1039 (www.clinicaltrials.gov, NCT NL78487.000.21) is an Open Label study evaluating the safety, tolerability and effects of splenic nerve stimulation with Galvani's neuromodulation system. Since it is an Open Label study, the…

Autoimmune epilepsy Modulated by IVIg - effects on Cortical Excitability, the AMICE study

1. Assessing the efficacy of IVIg in autoimmune epilepsy, both clinically and serologically.2. Identifying an objective marker of therapy response in epilepsy, measuring cortical excitability by TMS-EEG/EMG, in vivo.3. Providing evidence that…

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, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

To assess the safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids withdoses of at least 5 mg/day prednisone equivalent (glucocorticoindependent PMR).

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy

Rationale:Multifocal motor neuropathy (MMN) is a rare neuropathy characterized by progressive asymmetric weakness and atrophy without sensory abnormalities. MMN is considered a chronic immune-mediated neuropathy driven by the classical complement…

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD): AIM-CD

The primary objective of the study is to assess the efficacy, safety, and tolerability of ABBV 154 in comparison with placebo in subjects with moderately to severely active CD who had inadequate response to or were intolerant of prior biologics.