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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…

A randomised, open-label clinical trial assessing the efficacy and safety of mycophenolate mofetil versus azathioprine for induction of remission in treatment naive autoimmune hepatitis

To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.

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 Randomized, Placebo-Controlled, Double-blind, Multiple Dose, Phase 1 Study to Evaluate the
Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of SRK-001 in
Healthy Participants.

In this study, SRK-001 is being investigated to see how safe it is and how well it is tolerated when it is administered to healthy participants.We will also investigate how quickly and to what extent SRK-001 is absorbed, distributed, and eliminated…

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Primary Objective: • Efficacy: To evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on alkalinephosphatase (ALP) and total bilirubin at 12 months of treatment compared to placebo• Safety:…

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia (PATHWAY)

Primary - To evaluate the efficacy of parsaclisib in the treatment of participants with wAIHA.Secondary - To further evaluate the efficacy of parsaclisib in the treatment of participants with wAIHA.

Better after Choosing: Randomly allocated or patient preference based treatment with Filgotinib or TNFi in patients with active Rheumatoid Arthritis: the *BACH* study

primary objectives- To evaluate the actual preference of patients when they decide themselves which mode of action they want to use for treatment of rheumatoid arthritis.- To evaluate differences in treatment satisfaction between patients who choose…

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 Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients with Active Proliferative Lupus Nephritis

This study has been transitioned to CTIS with ID 2023-506359-68-00 check the CTIS register for the current data. This study investigates the safety and efficacy of the new drug anifrolumab in patients with Lupus Nephritis. The effect of anifrolumab…

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER BASKET STUDY TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH ANTI*N METHYL D ASPARTIC ACID RECEPTOR (NMDAR) OR ANTI*LEUCINE RICH GLIOMA INACTIVATED 1 (LGI1) ENCEPHALITIS

This study has been transitioned to CTIS with ID 2023-504226-18-00 check the CTIS register for the current data. This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in each of…

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 phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939

Primary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (two dose levels using EC2 capsules) on the immune system.Secondary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (…

Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, international, multicenter, non-inferiority trial (TODORA)

This study has been transitioned to CTIS with ID 2025-520513-30-00 check the CTIS register for the current data. We aim to optimize the treatment of rheumatoid arthritis patients using concentration measurements. By doing this we hope to reduce the…

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…

A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus

The primary objective is to assess whether combination treatment BLM+RTX will lead to reduced treatment failure and the improvement of pivotal, SLE-specific autoimmune phenomena compared SLE patients treated with standard of care.

COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in immune mediated inflammatory disease (IMID) patients, with special attention for COVID-19

1) To assess the effect of continuation of IA treatment in IMID patients during an infection compared to temporary interruption of the IA treatment with regard to serious infection.2) to study the incidence and risk factors for infection in IMID…

A first-in-human, randomized, double-blind, placebo-controlled study to evaluate, single ascending doses of CIT-013 in healthy volunteers with and without an intravenous lipopolysaccharide challenge and repeat dosing in healthy volunteers and patients with Rheumatoid Arthritis.

Objectives Part A: • To evaluate the safety and tolerability of CIT-013 after administration of single, ascending, IV doses in healthy volunteers.• To evaluate the pharmacokinetics of CIT-013 after administration of single, ascending, IV doses in…

A randomized, double-blind, placebo-controlled, first-in-human phase 1 study evaluating safety, tolerability, and pharmacokinetics of single ascending doses of SOL-116 (a humanized monoclonal anti-BSSL antibody) in healthy subjects and patients with rheumatoid arthritis.

Single dosingPrimary objective:• To evaluate the safety and tolerability of single ascending doses of SOL-116 in healthy subjects and rheumatoid arthritis (RA) patients.Secondary objective:• To determine single dose pharmacokinetic (PK)…

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD AGGLUTININ DISEASE WITHOUT A RECENT HISTORY OF BLOOD TRANSFUSION

Primary Objective:The purpose of Part A is to determine whether sutimlimab administration results in a greater than or equal to (>=)1.5 gram per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants…

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…