Trials / Completed
CompletedNCT03895801
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
A Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, 2-part Phase II Study on Replacement of Steroids by IFX-1 in Active Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- InflaRx GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Detailed description
Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody (ANCA) and generate C5a that engages C5a receptors on neutrophils. Patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease but not in remission. IFX-1 is as a monoclonal antibody specifically binding to the soluble human complement split product C5a, which results in nearly complete blockade of C5a induced biological effects. Therefore, IFX-1 may be effective in the treatment of subjects with AAV. In this Phase II study of 20 to 55 subjects with granulomatosis with GPA and MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IFX-1 | intravenously administered |
| DRUG | Placebo-IFX-1 | intravenously administered |
| DRUG | Glucocorticoid (GC) | orally administered |
| DRUG | Placebo-Glucocorticoid (Placebo-GC) | orally administered |
Timeline
- Start date
- 2019-04-03
- Primary completion
- 2021-04-14
- Completion
- 2021-06-08
- First posted
- 2019-03-29
- Last updated
- 2022-08-25
- Results posted
- 2022-08-25
Locations
76 sites across 11 countries: Belgium, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03895801. Inclusion in this directory is not an endorsement.