Autoimmunity Centers of Excellence (ACE)
Collaborating to find innovative treatments for autoimmune disease
Photo credit: NIAID, licensed under CC By 2.0. Image recolored from original.
Overview & Mission
The National Institute of Allergy and Infectious Diseases (NIAID) created the Autoimmunity Centers of Excellence (ACE) to encourage and enable collaborative research in the search for effective treatments for autoimmune diseases. The ACE program supports an integrated basic and clinical research program that focuses on treatment or prevention approaches that induce immune tolerance or modulate the immune system. The Centers that make up the ACE program will conduct clinical trials and basic research on new immune-based therapies for autoimmune diseases.
The ACE program strives to enhance interactions between scientists and clinicians to accelerate the translation of research findings into medical applications. By promoting better coordination and communication, the ACE program is one of NIAID’s primary vehicles for both expanding our knowledge and improving our ability to effectively prevent and treat autoimmune diseases.
5
Basic Research
Programs
5
Clinical Research
Programs
3
Collaborative
Research Projects
4
Actively Recruiting
Clinical Trials
About Autoimmunity
Autoimmune diseases are caused by the misdirection of an immune response toward the body's own tissues. The principal role of the immune system is to defend against infection. The body has safeguards to prevent the immune system from attacking its own tissues, but when these safeguards are breached, an autoimmune disease can result.
Collectively, autoimmune diseases afflict between 14 and 22 million Americans. Medical science has identified more than 80 clinically distinct autoimmune diseases, including systemic lupus erythematosus, type 1 diabetes, rheumatoid arthritis, Sjögren’s syndrome, multiple sclerosis, and chronic inflammatory bowel disease. Those suffering with autoimmune diseases often endure loss of function, disability, hospitalizations, outpatient visits, decreased productivity, and impaired quality of life.
Research Programs
The ACE program consists of three interrelated research components that include:
Basic Research Programs:
Perform basic investigation into one or more autoimmune diseases, and provide a foundation for additional studies
Clinical Research Programs:
Provide care and perform clinical studies across a broad spectrum of autoimmune diseases
Collaborative Projects:
Foster collaborations between different ACE programs for autoimmune disease research
These three components are not independent but rather represent a coherent approach to several of the most important challenges in the autoimmunity field. Please click on a research program for more information.
Basic Research Programs
Clinical Research Programs
Collaborative Projects
ACE Basic Research
University of Chicago
ACE Basic Research
Emory University
ACE Basic Research
Feinstein Institute for Medical Research
ACE Basic Research
Massachusetts General Hospital
ACE Basic Research
Weill Cornell Medical College
ACE Clinical Research
Feinstein Institute for Medical Research
ACE Clinical Research
Massachusetts General Hospital
ACE Clinical Research
University of Michigan
ACE Collaborative Project
ACE Collaborative Project
Clinical Trials
The ACE program brings together basic scientists and clinicians from leading research institutions to evaluate the safety and efficacy of treatment strategies for autoimmune diseases. ACEs investigators also explore the immune mechanisms underlying the agents evaluated in these trials – research that commonly is not included in other clinical trial programs.
Please click on a listed clinical trial for more information, including a description of each study and a link to the study record within the ClinicalTrials.gov database.
Actively Recruiting
Recruitment Completed
Concluded
Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
Description: This study aims to assess the effectiveness of mycophenolate mofetil (MMF) for 24 weeks in immunologically defined subsets of patients with systemic lupus erythematosus. It will evaluate treatment outcomes within these subsets and investigate gene expression patterns, immunologic changes accompanying disease improvement, and the relationship between immunologic changes and the loss of clinical response. See more information.
ClinicalTrials.gov Identifier: NCT05306873
Clinical Phase: Phase 2
Trial Locations: View at ClinicalTrials.gov
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
Description: This study is a proof-of-concept trial conducted at a single site, where 10 participants with systemic lupus erythematosus (SLE) and a history of cutaneous lupus will receive treatment with Tofacitinib for 25 days. The study will investigate the effects of Tofacitinib on photosensitivity caused by UVB exposure in individuals with SLE, using phototests, skin biopsies, and blood samples collected before and after treatment. See more information.
ClinicalTrials.gov Identifier: NCT05048238
Clinical Phase: Phase 1
Trial Locations: View at ClinicalTrials.gov
Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD)
Description: Immunoglobulin G4-Related Disease (IgG4-RD) is a chronic condition characterized by fibro-inflammatory effects on various organs. The primary objectives of this study are to assess the safety and effectiveness of adding elotuzumab to prednisone in reducing disease activity and improving outcomes in adult participants with active IgG4-RD affecting multiple organ systems, as measured by the IgG4-RD Responder Index. See more information.
ClinicalTrials.gov Identifier: NCT04918147
Clinical Phase: Phase 2
Trial Locations: View at ClinicalTrials.gov
Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis
Description: This prospective, multi-center study aims to evaluate the discontinuation of ocrelizumab treatment in patients with early relapsing multiple sclerosis. Participants will receive ocrelizumab according to a standard schedule for 12 months, followed by randomization into treatment groups. The treatment period will last for 48 months, and participants will receive either placebo or ocrelizumab infusions at specific intervals depending on their assigned group. See more information.
ClinicalTrials.gov Identifier: NCT05285891
Clinical Phase: Phase 4
Trial Locations: View at ClinicalTrials.gov
Transcutaneous Vagus Nerve Stimulation (tcVNS) in JIA
Description: This study aims to assess the safety and efficacy of transcutaneous vagus nerve stimulation (tcVNS) in alleviating pain and inflammation linked to juvenile idiopathic arthritis (JIA). tcVNS utilizes a device emitting mild electrical impulses through the skin to stimulate the vagus nerve and its branches in the head and neck. This stimulation induces a chemical response through the nerves and has proven effective in mitigating pain and inflammation in various medical conditions. See more information.
ClinicalTrials.gov Identifier: NCT05710640
Clinical Phase: Phase 2
Trial Locations: View at ClinicalTrials.gov
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
Description: This nationwide study aims to assess the potential benefits of additional COVID-19 vaccine doses in adults and children with autoimmune diseases who are taking immunosuppressive medications and may not have had a satisfactory response to initial or booster vaccinations. Participants who meet the criteria will receive an additional bivalent vaccine dose, and their immune response will be closely monitored via antibody and cell-mediated measurements. See more information.
ClinicalTrials.gov Identifier: NCT05000216
Clinical Phase: Phase 2
Study Design: View at ClinicalTrials.gov
Strategy to Prevent the Onset of Clinically-Apparent Rheumatoid Arthritis
Description: Rheumatoid arthritis (RA) is characterized by the immune system attacking the joints, leading to joint inflammation and symptoms like pain, stiffness, and swelling. This study aims to investigate whether hydroxychloroquine (HCQ) treatment can prevent the development of RA in individuals with high levels of the anti-CCP3 autoantibody and who do not currently have joint inflammation. Participants will receive a 12-month course of HCQ or HCQ placebo and be assessed for the onset of clinically apparent RA at 36 months. See more information.
ClinicalTrials.gov Identifier: NCT02603146
Clinical Phase: Phase 2
Study Design: View at ClinicalTrials.gov
JBT-101 in Systemic Lupus Erythematosus (SLE)
Description: The aim of this study is to assess the effectiveness, safety, and tolerability of JBT-101 (lenabasum) in individuals with systemic lupus erythematosus (SLE). JBT-101 is a synthetic activator that targets the endocannabinoid receptor type 2 (CB2) and may resolve innate immune responses without suppressing the immune system. Participants will receive two doses of JBT-101 or placebo orally for 84 days, followed by a 28-day follow-up period, and their maximum daily pain scores will be assessed at each visit using the Numerical Rating Scale (NRS). See more information.
ClinicalTrials.gov Identifier: NCT03093402
Clinical Phase: Phase 2
Study Results: View at ClinicalTrials.gov
Vitamin D3 in Systemic Lupus Erythematosus
Description: Systemic Lupus Erythematosus (SLE) is an autoimmune disease characterized by autoantibody production, immune complex deposition, and tissue inflammation. While the role of interferon (IFN) alpha in SLE development has been extensively studied, vitamin D deficiency is also prevalent among lupus patients, with vitamin D serving as an immune response regulator. This study aims to investigate the impact of vitamin D3 supplementation on IFN alpha expression in SLE patients over 12 weeks, with three treatment groups receiving varying daily doses of vitamin D3 or a placebo. See more information.
ClinicalTrials.gov Identifier: NCT00710021
Clinical Phase: Phase 2
Study Results: View at ClinicalTrials.gov
Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis
Description: The main objective of this study is to assess the impact of BAF312 (siponimod) on specific immune and neuronal cells in patients with Secondary Progressive Multiple Sclerosis (SPMS). This study complements a larger clinical trial (NCT01665144) that investigates the effectiveness and safety of BAF312 compared to a placebo in patients with SPMS, focusing on exploring the immunological and neuroprotective mechanisms of this novel treatment. See more information.
ClinicalTrials.gov Identifier: NCT02330965
Clinical Phase: Phase 3
Study Results: View at ClinicalTrials.gov
Use of Infliximab for the Treatment of Pemphigus Vulgaris
Description: This study aims to determine the safety and effectiveness of combining the synthetic antibody infliximab with prednisone as a treatment for adults with Pemphigus vulgaris (PV), a rare skin disorder characterized by skin and mucous membrane blistering. PV occurs when the immune system generates antibodies against specific proteins in the affected areas, but the cause for their production remains unknown. Infliximab targets tumor necrosis factor (TNF)-alpha, a signaling molecule that triggers immune responses, and this treatment has been successfully utilized in treating various autoimmune conditions like rheumatoid arthritis, Crohn's disease, and ankylosing spondylitis. See more information.
ClinicalTrials.gov Identifier: NCT00283712
Clinical Phase: Phase 2
Study Results: View at ClinicalTrials.gov
Anti-TNF Agents for the Treatment of Rheumatoid Arthritis
Description: Rheumatoid arthritis (RA) is a chronic autoimmune disorder that causes inflammation and progressive joint damage. Current treatments for RA target the immune system early in the disease progression to prevent joint damage and commonly include medications like methotrexate (MTX) and TNF-blocking agents. The study aims to evaluate the impact of etanercept and adalimumab, which are part of a newer class of biologic therapies known as TNF-alpha inhibitors, on memory B-cells in participants with RA who experience persistent joint inflammation, pain, stiffness, swelling, and warmth in peripheral joints. See more information.
ClinicalTrials.gov Identifier: NCT00837434
Clinical Phase: Phase 4
Study Results: View at ClinicalTrials.gov
Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH)
Description: Systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) is a severe and life-threatening complication of systemic sclerosis (SSc), an autoimmune disease of the connective tissues that affects various tissues and organs. Recent promising preclinical data and anecdotal clinical reports have demonstrated the effectiveness of immunotherapy in treating SSc-interstitial lung disease, another critical manifestation of SSc. This trial aims to evaluate whether the immunotherapy rituximab can significantly improve clinical disease progression in SSc-PAH patients. See more information.
ClinicalTrials.gov Identifier: NCT01086540
Clinical Phase: Phase 2
Study Results: View at ClinicalTrials.gov
Polyclonal Regulatory T Cells (PolyTregs) for Pemphigus
Description: Regulatory T cells (Tregs), a subtype of T cells, help regulate the immune system and may offer protection against autoimmune diseases. Utilizing these naturally occurring Tregs in the treatment of autoimmune diseases could potentially replace the need for chronic immunosuppressive therapies. This phase I trial, an open-label, dose-escalation, multicenter study, aims to investigate the safety and efficacy of Treg therapy in adult participants with active pemphigus, specifically focusing on those with cutaneous involvement. See more information.
ClinicalTrials.gov Identifier: NCT03239470
Clinical Phase: Phase 1
Study Results: View at ClinicalTrials.gov
Resources
The ACE program is one of multiple NIAID initiatives to research and treat autoimmune disorders. Please see below for other relevant autoimmune resources.
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