Wissenschaftliche Studien

Indikationsbereich

EudraCT-Nr.

Phase

Studientitel

Protokollnummer

Cutaneous Systemic Sclerosis

2022- 500332-11-00

NCT05559580

II

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

1366-0031

(VITALISScE)

GCA

2021- 002622-24

IIIb

A randomized, parallel-group, double-blind, placebo-controlled, multicenter trial to investigate the efficacy and safety of subcutaneously administered secukinumab in patients with new-onset of giant cell arteritis (GCA) who are in clinical remission and eligible for treatment with glucocorticoid-monotheraphy (GigAINt)

CAIN457R1DE01

(GigAINt)

SLE

2017- 005026-37

III

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

I4V-MC-JAHZ

GCA

2018- 001003-36

II

A Phase 2, randomized, double-blind placebo-controlled study to test the efficacy and safety of KPL-301 in giant cell arteritis

KPL-301-C001

EGPA

2014- 003162-25

III

Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)

MEA116841

SLE

2014- 004632-19

III

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 3 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

D3461C00004

(Tulip II SLE)

GCA

2015- 001758-14

III

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Sirukumab in the Treatment of Patients with Giant Cell Arteritis

201677

(Sirresta)

SLE

2016- 000625-39

III

A Multicentre, Randomised, Double-blind, Placebo-Controlled Phase 3 Extension Study to Characterise the Long-term Safety and Tolerability of Anifrolumab in Adult Subjects with Active Systemic Lupus Erythematosus

D3461C00009

(Tulip SLE LTE)

GCA

2011- 006022-25

III

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS

WA28119

(GiACTA)

Ankylosing Spondylitis

2013- 001090-24

III

A randomized, double-blind, placebo-controlled phase III multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long-term safety, tolerability and efficacy up to 3 years in subjects with active Ankylosing Spondylitis

CAIN457F2314

EPGA

2012- 004385-17

III

A Double-blind, Randomised, Placebo-controlled Study to Investigate the Efficacy and Safety of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard of Care Therapy.

MEA115921

Ankylosing Spondylitis

2010- 024529-18

III

A randomized, double-blind, placebo-controlled, multicenter study of secukinumab to demonstrate the efficacy at 16 weeks and to assess the long term safety, tolerability and efficacy up to 2 years in patients with active Ankylosing Spondylitis

CAIN457F2305

(MEASURE-1)