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Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.

Study Purpose

The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with GPA and MPA.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosis of GPA or 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 CYC or 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03895801
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	InflaRx GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anja Pfaff, PhDPeter A. Merkel, MD, MPH
Principal Investigator Affiliation	InflaRx GmbHUniversity of Pennsylvania
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Russian Federation, Spain, Sweden, Switzerland, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)

Additional Details

AAV is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by 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 81 subjects with GPA or MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.

Arms & Interventions

Arms

Experimental: Group A Experimental + active comparator

IFX-1 + reduced dose GC

Active Comparator: Group B Placebo + active comparator

Placebo-IFX-1 + standard dose GC

Placebo Comparator: Group C Experimental + placebo comparator

IFX-1 + Placebo-GC

Interventions

Drug: - IFX-1

intravenously administered

Drug: - Placebo-IFX-1

intravenously administered

Drug: - Glucocorticoid (GC)

orally administered

Drug: - Placebo-Glucocorticoid (Placebo-GC)

orally administered

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Clinical Site, Leuven, Belgium

Status

Recruiting

Address

Clinical Site

Leuven, ,

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