A Phase II, randomised, placebo-controlled, double-blind, parallel-group, efficacy and safety study of at least 48 weeks of oral BI 685509 treatment in adults with early progressive diffuse cutaneous systemic sclerosis

Clinical Studies - May 22, 2023 - May 22, 2026

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Bartz-Batliner Mira, Peischl Shirin, Gostic Dragana

A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants with Systemic Sclerosis

Clinical Studies - Apr 14, 2023 - Apr 14, 2026

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Bartz-Batliner Mira, Peischl Shirin, Gostic Dragana

A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase3 trial to evaluate efficacy and safety of secukinumab administered subcutaneously versus placebo,in combination with a glucocorticoid taper regimen, in patients with po...

Clinical Studies - Mar 10, 2023 - Mar 10, 2026

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Bartz-Batliner Mira, Peischl Shirin, Gostic Dragana

A randomized, four-arm, canakinumab placebo-controlled, participant, investigator and sponsor-blinded study investigating the safety, tolerability and efficacy of intra-articular canakinumab followed by intra-articular LNA043 in patients with knee os...

Clinical Studies - Dec 30, 2022 - Dec 31, 2025

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Peischl Shirin, Bartz-Batliner Mira, Peischl Riana, Hutz Carina Liane

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

Clinical Studies - Nov 30, 2022 - Dec 31, 2025

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Peischl Shirin, Peischl Riana, Bartz-Batliner Mira, Hutz Carina Liane

A double blind, randomized, placebo-controlled study to evaluate the efficacy and safety of PRA023 in Subject with Systemic Sclerosis associated with interstitial Lung Disease.

Clinical Studies - Aug 23, 2022 - Aug 23, 2024

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Peischl Riana, Peischl Shirin, Bartz-Batliner Mira, Hutz Carina Liane, Schmiedeberg Kristin

A Phase 3, Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA...

Clinical Studies - Jan 24, 2022 - Jan 17, 2025

Completed

Project leader: Rubbert-Roth Andrea
Members: Peischl Shirin, Peischl Riana, Bartz-Batliner Mira, Haller Christoph, Pirker Ian, Hutz Carina Liane

A randomized, parallel-group, double-blind, placebo-controlled, multicenter Phase III trial to investigate the efficacy and safety of secukinumab 300 mg and 150 mg administered subcutaneously versus placebo, in combination with a glucocorticoid taper...

Clinical Studies - Jan 1, 2022 - Jan 1, 2025

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Bartz-Batliner Mira, Peischl Shirin, Gostic Dragana

Real World Effectiveness of Upadacitinib on Early and Sustained Pain Control and Sleep Quality in Radiographic Axial Spondyloarthritis

Clinical Studies - Dec 10, 2021 - Dec 10, 2024

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Bartz-Batliner Mira, Peischl Shirin, Peischl Riana, Hutz Carina Liane

A Phase 2b Dose Ranging Study to Evaluate the Efficacy and Safety of Efavaleukin Alfa in Subjects with Active Systemic Lupus Erythematosus With Inadequate Response to Standard of Care Therapy.

Clinical Studies - Sep 8, 2021 - Apr 6, 2023

Aborted

Project leader: Rubbert-Roth Andrea
Members: Peischl Riana

Untersuchung der Sicherheit und Effektivität von mRNA basierten COVID-19 Impfungen bei Patienten mit rheumatoider Arthritis - ein exploratives Forschungsprojekt

Clinical Studies - Feb 1, 2021 - Dec 31, 2022

Completed

Project leader: Rubbert-Roth Andrea
Members: Schmiedeberg Kristin, Bartz-Batliner Mira, Peischl Riana, Peischl Shirin, Sasselli Clelia, Hutz Carina Liane

a randomized, double-blind, double-dummy, active-controlled, multicenter, 2-part Phase 2 study on replacement of steroids by IFX-1 in active granulomatosis with polyangiitis (GPA) and microscopic polyangitis (MPA)

Clinical Studies - Nov 1, 2020 - Nov 1, 2021

Completed

Project leader: Neumann Thomas
Members: Peischl Riana, Rubbert-Roth Andrea

a phase 3, double-blind, multicenter study of evaluate the long-term safety and efficacy of baricitinib in patients with SLE.

Clinical Studies - Aug 12, 2020 - Aug 12, 2022

Completed

Project leader: Rubbert-Roth Andrea
Members: Peischl Riana, Bartz-Batliner Mira

Upadacitinib treatment patterns, achievement of treatment targets and maintenance of response in moderate to severe Rheumatoid Arthritis patients in real-world practice

Clinical Studies - Aug 1, 2020 - Oct 31, 2023

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Bartz-Batliner Mira, Hutz Carina Liane, Peischl Riana, Peischl Shirin, Schmiedeberg Kristin

A two-year, phase III randomized, double-blind, parallel- group, placebo- controlled trial to evaluate the safety, efficacy, and tolerability of 300 mg s.c. secukinumab versus placebo in combination with SoC therapy in patients with active lupus neph...

Clinical Studies - Jul 13, 2020 - Jul 12, 2023

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Bartz-Batliner Mira, Hutz Carina Liane, Peischl Riana, Sasselli Clelia

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults with Dermatomyositis (DM)

Clinical Studies - Feb 5, 2020 - Dec 30, 2025

Ongoing

Project leader: Rubbert-Roth Andrea
Members: Hutz Carina Liane, Bartz-Batliner Mira, Peischl Riana, Sasselli Clelia

A Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis

Clinical Studies - Oct 3, 2019 - Jul 30, 2023

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Bartz-Batliner Mira, Neumann Thomas, Sasselli Clelia, Peischl Riana

A PHASE 4, MULTICENTER, SINGLE-ARM, OPENLABEL STUDY TO EVALUATE THE IMPACT OF APREMILAST (CC-10004) ON MRI OUTCOMES IN SUBJECTS WITH PSORIATIC ARTHRITIS

Clinical Studies - Jul 31, 2019 - Aug 31, 2021

Completed

Project leader: Rubbert-Roth Andrea
Members: Bartz-Batliner Mira, Neumann Thomas, Sasselli Clelia, Peischl Riana

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with polymyalgia rheumatica

Clinical Studies - Jul 4, 2019 - Jul 8, 2021

Automatically Closed

Project leader: Rubbert-Roth Andrea
Members: Neumann Thomas, Bartz-Batliner Mira, Peischl Riana, Sasselli Clelia

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sarilumab in patients with giant cell arteritis

Clinical Studies - Jul 4, 2019 - Jul 8, 2020

Aborted

Project leader: Rubbert-Roth Andrea
Members: Neumann Thomas, Bartz-Batliner Mira, Peischl Riana, Sasselli Clelia