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A multicenter, Phase 2a, open-label, non-randomized study evaluating the efficacy, safety, and tolerability of BIVV020 in adults with persistent/chronic immune thrombocytopenia (ITP)

To evaluate the effect of BIVV020 on the durabilityof platelet response in participants withpersistent/chronic immune thrombocytopenia (ITP)Secondary• To assess the safety and tolerability of BIVV020• To assess the pharmacokinetics (PK) of BIVV020•…

A multicenter, open-label, non-randomized, Phase 1b/2 study to evaluate the safety, pharmacokinetics, and efficacy of subcutaneous isatuximab in adults with warm autoimmune hemolytic anemia

Primary:• Part A: To evaluate the safety and tolerability of subcutaneous injections of isatuximab in adults with wAIHA.• Part B: To evaluate the efficacy of the selected dose in adults with wAIHA.Secondary:• Part A (Cohorts 2 and 3 only)-To…

A Long-Term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerabillity, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy

This study has been transitioned to CTIS with ID 2023-507052-69-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of ARGX-117 in adult participants with MMN

A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7240/ PRA023 in Subjects with Systemic Sclerosis Associated with Interstitial Lung Disease (SSc-ILD)

This study has been transitioned to CTIS with ID 2023-509743-27-00 check the CTIS register for the current data. x To assess the safety and tolerability of MK-7240/PRA023 in SSc-ILD x To compare the annual rate of change from Baseline in forced…

A Phase 2, Randomized, Placebo-controlled, Parallel Group, Double-blind, Proof-of-concept Study to Evaluate the Safety and Efficacy of Intravenous Efgartigimod in Adult Participants With Primary Sjögren*s Syndrome

Primary:• To evaluate the effect of efgartigimod IV compared to placebo on CRESSSecondary:• To evaluate the effect of efgartigimod IV compared to placebo on the histology of the parotid gland (selected sites only)• To evaluate the safety of…

CD8 T cell imaging by positron emission tomography with 89Zr-Df-IAB22M2C in giant cell arteritis and rheumatoid arthritis: a pilot study

Primary Objective: to evaluate arterial or synovial 89Zr-Df-crefmirlimab uptake on PET/CT in patients with GCA or RASecondary objectives are:1. Assessment of the relationship between 89Zr-Df-crefmirlimab uptake and the presence of CD8 T cells in…

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

This study has been transitioned to CTIS with ID 2024-513854-31-00 check the CTIS register for the current data. To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Rozanolixizumab in Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis

• To assess the efficacy of rozanolixizumab as measured by seizure freedom• To assess the efficacy of ozanolixizumab as measured by change in cognitive function• To assess the efficacy of ozanolixizumab as measured by use of rescue medication• To…

A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren*s Syndrome

The primary objective of this study is to evaluate the safety and tolerability of iscalimab at two dose levels (600 mg and 300 mg) in patients withSjögren*s Syndrome, who participated in the TWINSS core study,CCFZ533B2201.Secondary…

ANIfrolumab treatment for 24 weeks in patients with primary Sjögren*s syndrome - Efficacy and safety assessment in a randomized, double-blind, placebo-controlled phase-IIa proof-of-concept trial (ANISE-II)

This study has been transitioned to CTIS with ID 2024-516770-29-00 check the CTIS register for the current data. The objective of this study is to evaluate the clinical efficacy, biological effects and safety of anifrolumab treatment in pSS.

A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS

Primary* To evaluate the effect of RO7049665 on time to relapse following forced CCS tapering as measured by the hazard ratio between 7.5 mg RO7049665 and placebo.Secondary* To assess changes in alanine aminotransferase (ALT), aspartate…

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease

This study has been transitioned to CTIS with ID 2024-510727-19-00 check the CTIS register for the current data. The primary objective of this study is to observe the long-term efficacy, safety, and tolerability of repeated administration of…

TREAT EARLY ARTHRALGIA TO REVERSE OR LIMIT IMPENDING EXACERBATION TO RHEUMATOID ARTHRITIS

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A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of
Ravagalimab (ABBV-323) in Subjects with Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy

The main objective of Study M15-722 is to characterize the efficacy, safety, and tolerability of ravagalimab (ABBV-323) as induction treatment in subjects with moderately to severely active UC.

A Phase 2, Long-Term Extension (LTE) Study with Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus Who Have Completed the M19-130 Phase 2 Randomized Controlled Trial (RCT)

To evaluate the long-term safety and tolerability of elsubrutinib and upadacitinib given alone or as the ABBV-599 (elsubrutinib/upadacitinib) combination in SLE subjects who have completed the M19-130 Phase 2 study.

A Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Primary Objective:The primary objective is to demonstrate the efficacy of 1 or 2 dose regimens of HZN-825 versus placebo in subjects with diffuse cutaneous SSc, as determined by a comparison of change in forced vital capacity (FVC) % predicted after…

A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Risankizumab in Adult Subjects with Moderate to Severe Hidradenitis Supperativa.

The objective of this study is to assess the safety and efficacy of 2 dose levels of risankizumab versus placebo for the treatment of signs and symptoms of moderate to severe Hidradentitis Supperativa in adult subjects diagnosed for at least one…

A Phase 2 Study to Investigate the Safety and Efficacy of ABBV-105 and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects with Moderately to Severely Active Systemic Lupus Erythematosus

The main objective of this study is to evaluate the safety and efficacy of ABBV-105, upadacitinib, and ABBV-599 versus placebo for the treatment of signs and symptoms of SLE in participants with moderately to severely active SLE and to define doses…

Mesenchymal stem cells for angiogenesis and neovascularisation in digital ulcers of systemic sclerosis

This study has been transitioned to CTIS with ID 2024-515387-31-00 check the CTIS register for the current data. To investigate whether in patients with peripheral vascular complications related to SSc, intramuscular allogeneic BM-MSC therapy is…

A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren*s Syndrome

To determine the dose-response relationship of VAY736 for key efficacy and safety parameters.