Phase 2
N=57
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
Granulomatosis With Polyangiitis (GPA) · Microscopic Polyangiitis (MPA)
Bottom Line
View on ClinicalTrials.gov: NCT03895801 ↗Enrolled (actual)
57
Serious AEs
21.1%
Results posted
Aug 2022
Primary outcome: Primary: Percentage of Subjects Achieving Clinical Response — 16; 22; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IFX-1 (Drug); Placebo-IFX-1 (Drug); Glucocorticoid (GC) (Drug); Placebo-Glucocorticoid (Placebo-GC) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- InflaRx GmbH
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving Clinical Response |
16; 22; 10 | — |
| SECONDARY Percentage of Subjects With Clinical Remission |
14; 20; 10 | — |
| SECONDARY Change From Baseline in BVASv3 Total Score |
-13.8; -14.7; -16.6 | — |
| SECONDARY Vasculitis Damage Index (VDI) |
1.0; 1.5; 1.9 | — |
| SECONDARY Physician Global Assessment (PGA) |
0.4; 0.1; 0.7 | — |
| SECONDARY Estimated Glomerular Filtration Rate |
50.2; 57.0; 51.2 | — |
| SECONDARY Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) |
16; 24; 15 | — |
| SECONDARY Glucocorticoid Toxicity Index (GTI) |
0.8; 44.9; 26.1 | — |
| SECONDARY IFX-1 Plasma Concentrations (Pre-dose) |
67077.19; 47.80; 52597.85 | — |
| SECONDARY Plasma Concentrations of C5a |
10.6816; 39.2822; 13.6320 | — |
| SECONDARY IFX-1 Blocking Activity 10 nM |
100.571; 100.508 | — |
| SECONDARY IFX-1 Blocking Activity 2.5 nM |
98.260; 121.881 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA)
- Have ≥ 1 "major" item, or ≥ 3 other items, or ≥ 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
- Newly diagnosed or relapsed GPA or MPA that requires treatment with Cyclophosphamide (CYC) or Rituximab (RTX) plus GCs.
- Glomerular filtration rate ≥ 20 mL/min/1.73 m².
Exclusion Criteria
- Any other multi-system autoimmune disease.
- Require mechanical ventilation at screening.
- Known hypersensitivity to any investigational medicinal product and/or any excipient.
- Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Have required management of infections, as follows (a) Chronic infection requiring anti-infective therapy within 3 months before screening. (b) Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days of screening
- Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
- Evidence of Hep B, C and/ or HIV infection. Only subjects with documented negative historical results (within 4 weeks before screening) for Hep B,C Virus and HIV or a negative test by Screening can be included into the study.
- Abnormal laboratory findings at screening
- Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder
- Received CYC or RTX within 12 weeks before screening or within 12 weeks before CYC or RTX is started for remission induction within 2 weeks before screening.
- Received > 3 g cumulative intravenous GCs within 4 weeks before screening.
- Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
- Received an oral daily dose of a GC of > 80 mg prednisone equivalent within 2 weeks before screening.
- Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
- Received a live vaccination within 4 weeks before screening
- Either active or latent tuberculosis treatment is ongoing.
- Pregnant or lactating.
- Abnormal electrocardiogram.
- Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception
- Participation in an investigational clinical study during the 12 weeks before screening.
- Male subjects with female partners of childbearing potential unwilling to use contraception
Data sourced from ClinicalTrials.gov (NCT03895801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.