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A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER)

Part 1 - To determine effects of different ianalumab doses on ALT normalization at Week 24 in patients with AIH who are incomplete responders or intolerant to standard therapy.Part 2 - To confirm the efficacy (biochemical and histological remission…

A multicentre study for the long-term follow-up of HLH patients who received treatment with NI-0501, an anti-interferon gamma monoclonal antibody

Study Objectives:* To monitor the long-term safety profile of NI-0501* To assess HLH patients* survival after NI-0501 treatment* To assess duration of response to NI-0501 treatment (i.e. maintenance of HLH control)* To assess post-HSCT outcome…

A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the
efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of
angioedema attacks in adult subjects with hereditary angioedema type I or II

Primary Objective:• To investigate the efficacy of KVD900 compared to placebo in halting the progression of a peripheral or abdominal attack of hereditary angioedema (HAE).Secondary Objectives:• To investigate the safety and tolerability of KVD900…

An international, randomised, open label trial comparing a rituxmab based regimen with a standard cyclophosphamide/azathioprine regimen in the treatment of active, 'generalised' ANCA associated vasculitis

To assess the rates of preliminary response and sustained remission of AASV following rituximab (on the basis of former studies, 86% sustained remission expected with rituximab compared to 75% in control group).To assess safety of a rituximab…

Leflunomide and Hydroxychloroquine combination therapy
for primary Sjögren*s Syndrome

This study has been transitioned to CTIS with ID 2024-510904-36-00 check the CTIS register for the current data. To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized…

Regulation of the stress-axis by vitamin D3 in subjects with multiple sclerosis; a double-blinded, randomized, placebo-controlled study

The main aim of this study is to assess hypothesis A, and we will perform an exploratory analysis on hypothesis B.

Positron emission tomography with macrophage targeting to select individuals at risk for rheumatoid arthritis.

This study has been transitioned to CTIS with ID 2024-513538-40-02 check the CTIS register for the current data. To determine the value of quantitative whole body PET with [18F]PEG-Folate to predict development of clinical arthritis within one year…

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation

Primary ObjectiveTo evaluate the efficacy of lumacaftor/ivacaftor combination therapy (LUM/IVA) in subjects with cystic fibrosis (CF) 12 years of age and older who have at least one A455E mutation.Other Objectives* To explore the association between…

The BRIDGE-PMR study: B-cell depletion with Rituximab for Dose reduction of Glucocorticoids: Efficacy in PolyMyalgia Rheumatica

The proportion of patients in GC-free remission after 20 weeks.

A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren*s syndrome.

To evaluate the safety and efficacy of subcutaneousbelimumab (GSK1550188) and intravenous rituximab coadministrationin subjects with primary Sjögren*s syndrome.

Modulating regulatory T cell function in Juvenile Idiopathic Arthritis with Vitamin B3 (nicotinamide): a phase I/II trial focusing on safety and feasibility aspects in children with JIA.

NAM, well known as a dietary supplement, has also been extensively studied in humans in a variety of diseases in both children and adults. However, the safety, tolerability of NAM in children with JIA is yet unknown. Furthermore, studies performed…

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase

To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with sJIA in order to identifythe dose and regimen for continued development in this population.

Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.

Explore efficacy, safety, and feasibility (of an eventual future phase 3 trial) of intravenous immunoglobulins as treatment for patients with idiopathic inflammatory myopathies.

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 2 to 17 Years, with Polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) Followed by an Extension Phase

To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.

A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients

The main purpose of this study is to investigate how molgramostim improves the flow of oxygen from the lungs to the blood in patients with aPAP. The effect on lung function as a whole will also be studied, along with any improvement in the patients…