wip-completed-research-studies

TEMPO (GPA)

Full Name: Trimethoprim-Sulfamethoxazole Effects on the Nasal Microbiome in Granulomatosis with Polyangiitis
Study Dates: 2019-2021
NCT #: NCT03919435
Study Findings: Study results are pending.

InflaRx (GPA and MPA)

Full Name: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Investigate the Safety and Efficacy of Two Different Dose Regimens of IFX-1 as Add-On to Standard of Care in Subjects with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Study Dates: 2018-2021
NCT #: NCT03712345
Study Findings: This was a clinical trial to determine the effectiveness and safety of the investigational drug IFX-1 in treating patients with GPA and MPA. The study investigated two different doses of the study drug compared with a placebo when given in combination with standard of care treatments.

Study results are pending.

Mepolizumab Long-term Access Program (EGPA)

Full Name: Mepolizumab Long-term Access Program 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
Study Dates: 2016-2018
NCT #: NCT03298061
Study Findings: This study enabled subjects who participated in the MEA115921 study to continue treatment with mepolizumab.

ADVOCATE (GPA and MPA)

Full Name: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CCX168 (Avacopan) in Patients with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis Treated Concomitantly with Rituximab or Cyclophosphamide/Azathioprine
Study Dates: 2017-2020
NCT #: NCT02994927
Study Findings: This study demonstrated that the study drug CCX168 (avacopan) can effectively improve remission rates, kidney function, and overall quality of life of patients with ANCA-associated vasculitis, compared with standard therapy with steroids.

CLASSIC (GPA and MPA)

Full Name: A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects with Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Study Dates: 2014-2018
NCT #: NCT02222155
Study Findings: The goal of the CCX168 development program in ANCA-associated vasculitis (AAV) was to reduce or eliminate the use of chronic high dose glucocorticosteroids (steroids) in current standard of care treatment.  This study demonstrated that the study drug CCX168 (avacopan) was well tolerated in patients with AAV when added to current standard of care treatment.  This study led to a Phase 3 study called ADVOCATE (listed below).

MEA115921 (EGPA)

Full Name: 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
Study Dates: 2014-2017
NCT #: NCT02020889
Study Findings: Mepolizumab was shown to increase accrued time in remission, reduce frequency of relapse and exacerbation, and enable patients to reduce corticosteroid dose.

DCVAS (primary systemic vasculitis)

Full Name: The Diagnostic and Classification Criteria for Vasculitis study
Study Dates: 2013-2018
NCT #: NCT01066208
Study Findings: This was an observational study designed to develop and validate diagnostic criteria and to improve and validate classification criteria for primary systemic vasculitis. The updated classification criteria are intended to improve the quality of future clinical trials and clinical research because patients with specific diseases will be able to be reliably grouped for studies.

GiACTA (GCA)

Full Name: A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects with Giant Cell Arteritis
Study Dates: 2013-2018
NCT #: NCT01791153
Study Findings: This study demonstrated that weekly tocilizumab (Actemra®) treatment, initially in combination with a six-month steroid (glucocorticoid) taper, enabled significantly more patients with GCA to achieve sustained disease remission while also significantly reducing steroid exposure compared with taking steroids alone.

RITAZAREM (GPA)

Full Name: An International, Open Label, Randomized Controlled Trial Comparing Rituximab with Azathioprine as Maintenance Therapy in Relapsing ANCA-associated Vasculitis
Study Dates: 2012-2020
NCT #: NCT01697267
Study Findings: This study demonstrated that patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, with a prior history of relapse, who receive maintenance therapy with rituximab are more likely to remain in remission than those given azathioprine.

PEXIVAS (GPA and MPA)

Full Name: Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis
Study Dates: 2012-2019
NCT #: NCT00987389
Study Findings: This study demonstrated that the addition of plasma exchange to standard therapy does not reduce the risk for all-cause mortality or end-stage renal disease among patients with severe ANCA-associated vasculitis.

RaVeR (GPA and MPA)

Full Name: Prospective, Observational Safety Study of Patients with Granulomatosis with Polyangiitis (Wegener’s) or Microscopic Polyangiitis Treated with Rituximab
Study Dates: 2012-2017
NCT #: NCT01613599
Study Findings: This was a Phase IV, open-label, prospective study to characterize the long-term safety of rituximab in a 4-year observational registry of adult patients with GPA or MPA.  The study demonstrated that the safety profile of long-term (up to 4 years) repeated treatments with rituximab is consistent with the known overall safety profile of rituximab in patients treated for a shorter duration.

ABROGATE (GPA)

Full Name: Abatacept (CTLA4-Ig) for the Treatment of Relapsing, Non-Severe, Granulomatosis with Polyangiitis (Wegener’s)
Study Dates: 2015-2023
NCT #: NCT02108860
Study Findings: Study results are pending.

SELECT (GCA)

Full Name: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib in Subjects with Giant Cell Arteritis
Study Dates: 2019-2023
NCT #: NCT03725202
Study Findings: This study showed that patients with giant cell arteritis (GCA) who were treated with upadacitinib (RINVOQ®) with a steroid taper regimen were more likely to achieve sustained remission compared to patients receiving placebo with a steroid taper regimen.

MANDARA (EGPA)

Full Name: A Randomized, Double-blind, Active-controlled 52-week Study with an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab Compared to Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) in Patients Receiving Standard of Care Therapy
Study Dates: 2020-2023
NCT #: NCT04157348
Study Findings: Fasenra (benralizumab) and Nucala (mepolizumab) were similarly effective at inducing remission in EGPA.  It also showed that eliminating oral glucocorticoids in EGPA treatment is now achievable using eosinophil-focused therapies, though further research is necessary.