Clinical trials: Autoinflammatory Diseases
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
Acute Gout Flare, Gout Attack
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
- Conditions
- Acute Gout Flare, Gout Attack, Gout Flare, Gouty Arthritis
- Trial name
- NCT05658575
- Testing
- Dapansutrile
- Where
- 40 sites in United States, France and 3 more
- Volunteers
- 300 people
- Sponsor
- Olatec Therapeutics, Inc.
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)
This Phase 1b basket trial will investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of RAY121, a inhibitor of classical complement pathway, after multiple dose…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06371417
- Testing
- RAY121
- Where
- 77 sites in United States, Australia and 18 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
Age-Related Macular Degeneration, Allergies
Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
To collect, preserve, and/or distribute annotated biospecimens and associated medical data to institutionally approved, investigator-directed biomedical research to discover and develop new treatments, diagnostics, and…
- Conditions
- Age-Related Macular Degeneration, Allergies, Alpha-Gal Syndrome, Alzheimer Disease
- Trial name
- NCT05635266
- Testing
- Specimen sample
- Where
- United States
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Sanguine Biosciences
Behcet Syndrome, Behcet Disease
Topical Pentoxifylline Gel on Behcet's Disease Genital Ulcers
Behçet's Disease (BD) is a complex, chronic, relapsing, multi-system inflammatory disorder that is characterized by oral ulcers, genital ulcers in addition to ocular and skin symptoms.
- Trial name
- NCT04186559
- Testing
- Topical Pentoxifylline Gel (Vehicle +PTX)
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Silk Road Therapies, Inc.
Familial Mediterranean Fever, FMF
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
The primary objective is to evaluate the main pharmacokinetic (PK) parameters, efficacy, and safety of goflikicept (GFC) in children and adolescents with colchicine-resistant or colchicine-intolerant familial Mediterranean fever…
- Trial name
- NCT07880886
- Testing
- RPH-104
- Where
- 3 sites in Russia
- Volunteers
- 18 people
- Sponsor
- R-Pharm
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
Schnitzler Syndrome, Urticarial Vasculitis With Monoclonal Immunoglobulin M Component, Schnitzler (Disorder)
Study of the Efficacy and Safety of RPH-104 in Adult Subjects With Schnitzler Syndrome
The primary goal of the study is to assess the efficacy and safety of RPH-104 in subjects with Schnitzler Syndrome using Schnitzler Disease Activity Score (SDAS), which includes the Physician's Global Assessment (PGA) and the…
- Trial name
- NCT04213274
- Testing
- 80 mg RPH-104
- Where
- 4 sites in United States
- Sponsor
- R-Pharm Overseas, Inc.
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
Efficacy, Safety and Tolerability of ACZ885 in Pediatric Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
This trial will provide long-term safety, efficacy and tolerability of ACZ885 in CAPS patients that completed the CACZ885D2307 study
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT01576367
- Testing
- ACZ885
- Where
- 12 sites in Belgium, Canada and 5 more
- Volunteers
- 17 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
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
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS)
Ilaris NIS in Korea
This is a study to evaluate safety and effectiveness of Ilaris in adult and pediatric patients receiving the drug in a clinical setting for any of the following indications, Hereditary Periodic Fever Syndromes…
- Conditions
- Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS)
- Trial name
- REASSURE (NCT06838143)
- Testing
- Ilaris
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Novartis Pharmaceuticals
Behçet Disease
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD)…
- Trial name
- BEAN (NCT04528082)
- Testing
- Apremilast
- Where
- 27 sites in France, Greece and 6 more
- Volunteers
- 60 people
- Sponsor
- Amgen
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
Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome
Efficacy and Safety Study of Canakinumab Administered for 6 Months (24 Weeks) in Japanese Patients With Cryopyrin-associated Periodic Syndromes Followed by an Extension Phase
To date there are no approved effective therapies for the treatment of cryopyrin-associated periodic syndromes (CAPS) including Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS), or Neonatal Onset…
- Conditions
- Cryopyrin-associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Trial name
- NCT00991146
- Testing
- canakinumab
- Where
- 3 sites in Japan
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP)
Phase 1b Long-term Extension Trial of RAY121 in Immunological Diseases (RAINBOW-LTE Trial)
This is a long-term extension trial of RAY121 in patients with immunological diseases such as antiphospholipid syndrome (APS), bullous pemphigoid (BP), Behçet's Syndrome (BS), dermatomyositis (DM), immune-mediated necrotizing…
- Conditions
- Antiphospholipid Syndrome (APS), Bullous Pemphigoid (BP), Behçet's Syndrome (BS), Dermatomyositis (DM)
- Trial name
- NCT06723106
- Testing
- RAY121
- Where
- 62 sites in Australia, Austria and 17 more
- Volunteers
- 144 people
- Sponsor
- Chugai Pharmaceutical
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
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
Behcet Disease
A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease
The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD) score of 20 or more in participants with…
- Trial name
- BEGIN (NCT02505568)
- Testing
- Infliximab
- Where
- 5 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Janssen Korea, Ltd., Korea
Familial Mediterranean Fever
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or…
- Trial name
- NCT01075906
- Testing
- colchicine sprinkle capsules
- Where
- 10 sites in United States, Armenia and 2 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.