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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2021
• Main ID: NCT03895801
• Date of registration: 08/03/2019
• Prospective Registration: Yes
• Primary sponsor: InflaRx GmbH
• Public title: Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. IXchange
• Scientific title: 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)
• Date of first enrolment: April 3, 2019
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03895801
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Czechia, Denmark, France, Germany, Italy, Netherlands, Russian Federation, Spain, Sweden, Switzerland, United Kingdom

Contacts

• Name: Anja Pfaff, PhD
• Affiliation: InflaRx GmbH

• Name: Peter A. Merkel, MD, MPH
• Affiliation: University of Pennsylvania

Key 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Microscopic Polyangiitis (MPA)

Granulomatosis With Polyangiitis (GPA)

Intervention(s)

Drug: Glucocorticoid (GC)

Drug: Placebo-Glucocorticoid (Placebo-GC)

Drug: Placebo-IFX-1

Drug: IFX-1

Primary Outcome(s)

Proportion of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score [BVAS] of =50% compared to baseline and no worsening in any body system) [Time Frame: Week 16]

Secondary Outcome(s)

Adverse Events of Special Interest (AESIs) [Time Frame: Week 24]

Glucocorticoid (GC)-induced toxicity of standard-dose GC and reduced-dose GC with IFX-1 treatment [Time Frame: Week 24]

Pharmacokinetic and pharmacodynamic modelling of IFX-1 treatment [Time Frame: Week 24]

Serious adverse events (SAEs) [Time Frame: Week 24]

Treatment-emergent adverse events (TEAE) [Time Frame: Week 24]

Secondary ID(s)

IFX-1-P2.5

Source(s) of Monetary Support

Please refer to primary and secondary sponsors