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A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects

The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…

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 phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of apremilast (CC-10004) in subjects with early, oligoarticular psoriatic arthritis despite initial stable treatment with either non-steroidal anti-inflammatory drugs (NSAIDs) and/or <=1 conventional synthetic disease-modifying antirheumatic drugs (DMARD).

Primary Objective• To evaluate the efficacy of apremilast 30 mg BID * NSAIDs and/or csDMARDs vs. Placebo * NSAIDs and/or csDMARDs in subjects with early oligoarticular PsA, assessed by modified MDA (MDA-Joints).Secondary Objectives · To evaluate the…

52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or an intolerance to ursodeoxycholic acid (UDCA)

Primary: • To evaluate the safety and effect on cholestasis of two seladelpar regimens (5 mg/day titrated to 10 mg/day and 10 mg/day) over 52 weeks of treatment compared to placeboKey Secondary: • To evaluate the effect of seladelpar on…

the effect of hyperbaric oxygen therapy on immune response and oxidative stress

To explore the effects of HBOT on immunologic parameters and oxidative stress.

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…

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LNP023 following a single oral dose of [14C]LNP023 in healthy male/female subjects.

The purpose of this study is to investigate how quickly and to what extent LNP023 is absorbed, broken down, and eliminated from the body (this is called pharmacokinetics). LNP023 will be labelled with 14 carbon (14C) and is thus radioactive. In this…

A randomized, double-blind, placebo-controlled single and multiple ascending dose study of the safety, tolerability and pharmacokinetics of oral doses of SAR443122 in healthy adult subjects.

This study will be performed in a maximum of 97 healthy volunteers. The study will be performed in 2 parts, Part 1 (split up in Part 1a and Part 1b) and Part 2. A single dose of SAR443122 (or placebo [only in Part 1a]) will be administered in Part 1…

INDIGO: Comparing pharmacokinetic parameters of golimumab 50 mg and golimumab 100 mg with a prolonged dose interval in patients with a rheumatic disease, a within-subject controlled study*

The aim of this study is to describe pharmacokinetic parameters of the following golimumab regimens: 50 mg every month, 100 mg every one-and-a-half month and 100 mg every two months, in patients with a rheumatic disease.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus.

To evaluate the effect of baricitinib 4-mg QD and background standard-of-care therapy compared with placebo and background standard-of-care therapy on SLE disease activity.

A single-center, open-label study to evaluate the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LOU064 following a single dose of [14C]LOU064 administered orally or intravenouslyl in healthy male and female subjects at steady-state.

The purpose of this study is to investigate how quickly and to what extent LOU064 is absorbed, broken down, and eliminated from the body. LOU064 will be labeled with 14 carbon (14C) and is thus radioactive. In this way LOU064 can be traced in blood…

PeRsonalIzed MEdicine in Rheumatoid Arthritis (PRIMERA trial): a multicenter, single-blinded, randomized controlled trial comparing usual care with a tailor-made approach

This study has been transitioned to CTIS with ID 2024-511530-12-01 check the CTIS register for the current data. We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active
Ulcerative Colitis

The objective of Study M14-675 (Phase 3 induction) is to evaluate the efficacy and safety of upadacitinib 45 mg once daily (QD) compared to placebo in inducing clinical remission (per Adapted Mayo score) in subjects with moderately to severely…

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…

Stop TPO-receptor agonist in ITP Patients

Find/confirm percentage of remission after discontinuing TPO-RA in persistent and chronic ITP patients.

The efficacy of Methotrexate for glucocorticoid dose reduction in recently diagnosed polymyalgia rheumatica patients: a double-blind randomized placebo controlled multicenter clinical trial.

Primary Objective: To determine whether in recently diagnosed PMR patients concomitant treatment to glucocorticoids with MTX 25 mg/week compared to a placebo will lead to a higher proportion of GC-free remission at 52 weeks. Secondary Objectives: To…

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…

A Phase 1, Randomized, Single-Center Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of R289 in Healthy Subjects.

Part 1 - Single Ascending Dose (SAD) Capsule Formulation:Primary objective:To investigate the safety and tolerability of single oral doses of R289 capsules in healthy subjects.Secondary objective:To characterize the pharmacokinetic (PK) profiles of…

A randomised, double-blind, placebo controlled, single and multiple dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of NMD670 in male and female healthy subjects and patients with myasthenia gravis.

* 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…