Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 81

Inclusion Criteria

1. Male or female, = 18 years of age.
2. Written informed consent obtained from subject.
3. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference (CHCC).
4.History of positive antigen-specific ANCA testing since the time of diagnosis or at screening, or documented evidence of either anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) (for newly diagnosed subjects a recent positive antigen-specific ANCA testing is mandatory for inclusion)
5. Have = 1 major” item, or = 3 other items, or = 2 renal items on the Birmingham Vasculitis Activity Score Version 3 (BVASv3).
6. Newly diagnosed or relapsed GPA or MPA that requires treatment with CYC or RTX plus GCs.
7. Estimated glomerular filtration rate (eGFR) = 20 mL/min/1.73 m².
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

1. Any other multi-system autoimmune disease as listed in Appendix 18.4.
2. Require mechanical ventilation because of alveolar hemorrhage at screening.
3. Known hypersensitivity to any investigational medicinal product (IMP) (i.e. GC, IFX-1) and/or any excipients.
4. Subject with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
5. Have required management of infections, as follows:
a. Chronic infection requiring anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria)
b. Use of intravenous antibacterials, antivirals, anti-fungals, or anti parasitic agents within 30 days of screening.
6. Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
7. Hepatitis B virus, (HBV) hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral test showing evidence of active or chronic viral infection at screening or a documented history of HIV, or an active or chronic hepatitis B or hepatitis C infection.
8. Any of the following abnormal laboratory findings at screening:
a. White blood cells < 3,500/mm3
b. Platelet count < 100,000/mm3
c. Transaminase values (AST and/or ALT) = 2.5 times the upper limit of normal range (ULN)
d. Total bilirubin = 1.5 times ULN
e. Alkaline Phosphatase (ALP) > 3 times ULN
9. Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder except squamous cell or basal cell carcinomas of the skin and cervical carcinoma in situ with curative surgical treatment.
10. Received CYC or RTX within 12 weeks before screening; if on AZA, MMF or MPS or MTX at the time of screening, these drugs must be withdrawn prior to receiving the first dose of CYC or RTX.
11. Received > 3 g cumulative intravenous GCs within 4 weeks before screening.
12. Received an oral daily dose of a GC of > 10 mg prednisone-equivalent for more than 6 weeks continuously prior to screening.
13. Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before screening.
14. Received a live vaccination within 4 weeks before screening or planned between screening and Week 24.
15. Either active or latent tuberculosis treatment is ongoing.
16. Pregnant or lactating.
17. Clinically significant abnormal electrocardiogram (ECG) during screening.
18. Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index < 1%) during treatment and for at least 3 months after last administration of IFX- 1/Placebo-IFX-1 (or up to 12 months, the timeframes for Standard of Care agents have to be considered as described in the respective Prescribing Information/SPCstimeframes). Contraception methods regarded as highly effective methods and the duration of contraception are further described in Section 7.7.
19. Evidence or suspicion that the subject might not comply with the requirements of the study protocol.
20. The subject is an employee or direct relative of an employee of the sponsor (InflaRx GmbH).
21. The subject is imprisoned or lawfully kept in an institution.
22. The subject has participated in an investigational clinical study during the 12 weeks (or 5 times the half-life of the previou

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Efficacy and safety study of a monoclonal antibody to replace steroids for treatment of patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) diseases.

Recruitment & Eligibility

Study & Design

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