Clinical trials: Auto-inflammatory Disease
Healthy Subjects
Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects
This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only)…
- Trial name
- NCT03980080
- Testing
- OSE-127
- Where
- Belgium
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- OSE Immunotherapeutics
Crohn's Disease
Safety and Efficacy of FURESTEM-CD Inj. in Patients With Moderately Active Crohn's Disease(CD)
The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with moderately active Crohn's disease after injection for 28days.
- Trial name
- NCT02000362
- Testing
- Stem cells
- Where
- 7 sites in South Korea
- Volunteers
- 24 people
- Sponsor
- Kang Stem Biotech Co., Ltd.
Cryopyrin-Associated Periodic Syndromes (CAPS)
HL2351 CAPS Phase II Study
This is an open label, single arm trial to evaluate the efficacy, safety, and pharmacokinetics of HL2351 in patients with cryopyrin associated periodic syndromes (CAPS).
- Trial name
- NCT02853084
- Testing
- HL2351
- Where
- South Korea
- Volunteers
- 8 people
- Sponsor
- Handok Inc.
Inflammation
Effects of Transvenous Vagus Nerve Stimulation on Immune Response: a Pilot Study
The purpose of this study is to assess the effect of transvenous vagus nerve stimulation (tVNS) on the immune response. In the human endotoxemia model, intravenously administered endotoxin (lipopolysaccharide [LPS]) elicits a…
- Trial name
- NoSIRS (NCT01944228)
- Testing
- Vagal Nerve Stimulation
- Where
- Netherlands
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Hereditary Periodic Fevers
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
This study is to determine whether canakinumab is able to induce and maintain a clinically meaningful reduction of disease activity in participants with Hereditary Periodic Fevers (HPF) compared to placebo.
- Trial name
- NCT02059291
- Testing
- Canakinumab
- Where
- 65 sites in United States, Belgium and 14 more
- Volunteers
- 203 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Juvenile Idiopathic Arthritis, Hereditary Periodic Fevers
A Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis or Hereditary Periodic Fevers Who Participated in the CACZ885G2301E1, CACZ885G2306 or CACZ885N2301 Studies
The objective of this extension protocol is to collect safety data (serious and non-serious adverse events) and to provide continuous canakinumab to patients in France who completed study CACZ885G2301E1(NCT00891046), CACZ885G2306…
- Trial name
- NCT02334748
- Testing
- canakinumab
- Where
- 3 sites in France
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.
- Trial name
- CoTikiS (NCT04882007)
- Testing
- OSE-127
- Where
- 55 sites in Belarus, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- OSE Immunotherapeutics
Periodic Fevers Syndrome
An Extention Study of Safety of Canakinumab in Japanese Patients With Periodic Fever Syndromes
The primary objective of this study was to evaluate safety and tolerability of ACZ885 in this extension study. This extension study offered the opportunity for participants who completed Epoch 4 of the preceding CACZ885N2301…
- Trial name
- NCT02911857
- Testing
- Canakinumab (AIN457)
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Relapsing-remitting Multiple Sclerosis
Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis
The purpose of this study was to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), and to characterize its safety and…
- Trial name
- NCT00879658
- Testing
- BAF312
- Where
- 72 sites in United States, Canada and 10 more
- Volunteers
- 297 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Familial Cold Autoinflammatory Syndrome
Study of Safety, Tolerability and Efficacy of DFV890 in Participants With Familial Cold Auto-inflammatory Syndrome (FCAS)
The purpose of this phase II study was to assess the safety, tolerability and efficacy of DFV890 in participants with FCAS.
- Trial name
- DFV890-FCAS (NCT04868968)
- Testing
- DFV890
- Where
- 3 sites in United States, France and 1 more
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Juvenile Idiopathic Arthritis (SJIA)
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
- Trial name
- ß-SPECIFIC 4 (NCT02296424)
- Testing
- ACZ885 150 mg (Canakinumab)
- Where
- 50 sites in United States, Austria and 14 more
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
Systemic Juvenile Idiopathic Arthritis
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile…
- Trial name
- NCT02396212
- Testing
- Canakinumab
- Where
- 7 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Still's Disease, Adult-Onset
Therapeutic Use of Tadekinig Alfa in Adult-onset Still's Disease
The objective of this study is to assess safety, tolerability and early signs of efficacy of the investigational drug Tadekinig alfa in Adult-onset Still's disease, a rare polygenic auto-inflammatory disorder for which treatment…
- Trial name
- NCT02398435
- Testing
- Tadekinig alfa (recombinant human IL-18 binding protein)
- Where
- 20 sites in France, Germany and 1 more
- Volunteers
- 23 people
- Sponsor
- AB2 Bio Ltd.
Multiple Sclerosis
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events
- Trial name
- NCT02232061
- Testing
- Fingolimod
- Where
- 4 sites in Belgium, Germany and 1 more
- Volunteers
- 6 people
- Sponsor
- Novartis Pharmaceuticals
Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis
Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS
The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection…
- Conditions
- Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
- Trial name
- NCT04018599
- Testing
- 40 mg MSB11022
- Where
- 2 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi SwissBioSim GmbH