Clinical trials: Autoinflammatory Disorders
Systemic Juvenile Idiopathic Arthritis
An Open-label, Multi-arm, Non-comparative Safety and Tolerability Study of Canakinumab (ACZ885) in Patients With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
This two-part open-label, multi-arm, non-comparative study will collect long-term safety, efficacy and tolerability data from patients who were responsive to canakinumab from study CACZ885G2301E1 (Cohort 1), and from patients who…
- Trial name
- β-SPECIFIC 4Pa (NCT01676948)
- Testing
- ACZ885, Canakinumab
- Sponsor
- Novartis Pharmaceuticals
NALP3 Mutation
Safety, Efficacy, Pharmacokinetics, Pharmacodynamics of ACZ885 in Patients With NALP3 Mutations and Clinical Symptoms
This study will investigate the clinical efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of ACZ885, administered intravenously and subcutaneously to patients with NALP3 mutations whose clinical symptoms are…
- Trial name
- NCT00487708
- Testing
- canakinumab
- Where
- 10 sites in France, Germany and 3 more
- Volunteers
- 34 people
- Sponsor
- Novartis Pharmaceuticals
VEXAS Syndrome
A 52-Week Study Evaluating the Efficacy and Safety of Arumakimig (MAS825) in Participants With VEXAS Followed by Open-Label Extension (OLE) Period
The purpose of this study is to evaluate clinical efficacy and safety of arumakimig (MAS825) compared to placebo in patients with Vacuoles, E1 Enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome.
- Trial name
- NCT07748624
- Testing
- Arumakimig, Oral glucocorticoids
- Where
- 4 sites in Japan
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Behçet's Syndrome
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's Disease
The main objective of this study is to evaluate the efficacy and safety of apremilast in the treatment of oral ulcers in adults with active Behçet's disease (BD).
- Trial name
- NCT02307513
- Testing
- Apremilast
- Where
- 63 sites in United States, France and 8 more
- Volunteers
- 207 people
- Sponsor
- Amgen
Healthy Volunteers, Cryopyrin Associated Periodic Syndrome
Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With IZD334
This is a first in human (FIH), single-centre, double -blind, randomised, cross-over, SAD followed by a MAD study of IZD334 conducted in healthy adult participants as well as an open-label cohort in adult patients with CAPS.
- Trial name
- NCT04086602
- Testing
- IZD334
- Where
- Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Inflazome UK Ltd
Healthy Volunteers
A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study
The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.
- Trial name
- NCT02175056
- Testing
- HL2351, Kineret(Anakinra)
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Handok Inc.
NOMID, CINCA Syndrome
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous…
- Trial name
- NCT00770601
- Testing
- Canakinumab
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
NLRC4-GOF, AIFEC (Autoinflammation With Infantile Enterocolitis), XIAP Deficiency, CDC42 Mutations
Study to Evaluate the Efficacy, Safety and Tolerability of MAS825 in Patients With Monogenic IL-18 Driven Autoinflammatory Diseases, Including NLRC4-GOF, XIAP Deficiency, or CDC42 Mutations
This study is a Phase 2 trial designed to evaluate the clinical efficacy, safety, and tolerability of MAS825 in patients with NLRC4-GOF, XIAP deficiency, or CDC42 mutations.
- Trial name
- MASter-1 (NCT04641442)
- Testing
- MAS825
- Where
- 12 sites in United States, Czechia and 5 more
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever
A Study to Describe a Group of Spanish Patients With FMF and to Identify Suboptimally Treated Patients With Minimal Disease Activity and Its Impact on Quality of Life
A retrospective, non-interventional, single-center study conducted in Spain, based on the collection of data from the medical histories of patients with Familial Mediterranean fever (FMF) diagnosed during childhood from January…
- Trial name
- NCT06923124
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Familial Mediterranean Fever
Efficacy and Safety of Canakinumab in Patients With Colchicine Resistant Familial Mediterranean Fever
Establish the safety and efficacy of 3 months treatment with canakinumab in patients with colchicine resistant Familial Mediterranean Fever.
- Trial name
- NCT01088880
- Testing
- Canakinumab
- Where
- Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Behcet's Disease Uveitis
Efficacy and Safety Study of Gevokizumab to Treat Behcet's Disease Uveitis
The objective of this study is to assess the efficacy and safety of gevokizumab in treating Behcet's disease uveitis (BDU).
- Trial name
- EYEGUARD™-US (NCT02258867)
- Testing
- Gevokizumab
- Where
- 8 sites in United States
- Volunteers
- 4 people
- Sponsor
- XOMA (US) LLC
Non-infectious Uveitis
Safety and Efficacy of AIN457 in Noninfectious Uveitis
This study was performed to evaluate the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.
- Trial name
- NCT00685399
- Testing
- AIN457, AIN 457
- Where
- 23 sites in United States, Germany
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS)
Clinical Outcomes and Safety: A Registry Study of Ilaris (Canakinumab) Patients
The purpose of this observational study is to collect additional information regarding long-term safety and effectiveness of Ilaris in the treatment of CAPS patients in clinical practice.
- Conditions
- Cryopyrin-associated Periodic Syndromes (CAPS), Familial Cold Autoinflam Syn (FCAS), Muckle-wells Syn (MWS), Neonatal Onset Multisystem Inflam Disease (NOMID)
- Trial name
- B-Confident (NCT01213641)
- Where
- 17 sites in United States, Austria and 3 more
- Volunteers
- 288 people
- Sponsor
- Novartis Pharmaceuticals
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.
Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria
Rilonacept for Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Inflammatory symptoms of Cryopyrin-Associated Periodic Syndrome (CAPS) are due to mutations in a the NLRP-3 gene (previously known as Cold Induced Autoinflammatory Syndrome-1 or CIAS1).
- Conditions
- Familial Cold Autoinflammatory Syndrome (FCAS), Familial Cold Urticaria, Muckle-Wells Syndrome (MWS), Genetic Diseases, Inborn
- Trial name
- NCT00288704
- Testing
- rilonacept 160 mg
- Where
- 24 sites in United States
- Volunteers
- 104 people
- Sponsor
- Regeneron Pharmaceuticals
Familial Mediterranean Fever, FMF
Safety and Efficacy of RPH-104 Used to Prevent Recurrent Fever Attacks in Adult Patients With Colchicine Resistant or Colchicine Intolerant Familial Mediterranean Fever
The purpose of this study is to assess safety and efficacy of the long-term treatment with RPH-104 at doses of 80 or 160 mg once every 2 weeks (q2w) in patients with familial Mediterranean fever (FMF) with colchicine resistance…
- Trial name
- NCT05190991
- Testing
- RPH-104
- Where
- 8 sites in Armenia, Russia and 1 more
- Volunteers
- 60 people
- Sponsor
- R-Pharm International, LLC
Behçet's Disease
A Study of Efficacy and Safety of Hemay005 Tablets in Patients With Behçet's Disease
This is a phase 3, multi-center, randomized, placebo-controlled, double-blind, parallel-group study with an equal randomization among the Hemay005 high dose, lower dose and placebo treatment groups.
- Trial name
- NCT06145893
- Testing
- Hemay005
- Where
- 22 sites in China
- Volunteers
- 162 people
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Familial Mediterranean Fever (FMF )
A Study to Evaluate Efficacy and Safety of Anakinra in Chinese Patients With Colchicine-resistent FMF
The purpose of this study is to evaluate the efficacy and safety of anakinra in Chinese patients with colchicine-resistand Familial Mediterranian Fever (FMF).
- Trial name
- NCT06666335
- Testing
- Anakinra
- Sponsor
- Swedish Orphan Biovitrum
Familial Mediterranean Fever, Still Disease
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
This study aims to assess and characterize the treatment patterns, and long-term clinical outcomes and demographic characteristics of patients diagnosed with Familial Mediterranean fever (FMF) and Still's disease (including…
- Conditions
- Familial Mediterranean Fever, Still Disease, Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still Disease
- Trial name
- NCT07517250
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- Novartis Pharmaceuticals
Autoimmune Encephalitis, Early-stage Panencephalitis
Monitoring of Outcomes of Cellular and Exosome-based Therapies in Autoinflammatory and Post-infectious Neuroinflammatory Syndromes
This is a prospective, non-randomized, observational registry study evaluating the clinical outcomes of patients with autoimmune or post-infectious neuroinflammatory syndromes receiving stem cell-derived biologics (including…
- Conditions
- Autoimmune Encephalitis, Early-stage Panencephalitis, Neuroinflammatory Demyelination
- Trial name
- NCT07145502
- Testing
- Allogeneic MSC infusions (IV)
- Where
- Poland
- Volunteers
- 76 people
- Sponsor
- Biocells Medical