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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03895801
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : August 10, 2021
Information provided by (Responsible Party):
InflaRx GmbH

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA) Drug: IFX-1 Drug: Placebo-IFX-1 Drug: Glucocorticoid (GC) Drug: Placebo-Glucocorticoid (Placebo-GC) Phase 2

Detailed Description:

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 55 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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)
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : April 14, 2021
Actual Study Completion Date : June 8, 2021

Arm Intervention/treatment
Experimental: Group A Experimental + active comparator
IFX-1 + reduced dose GC
Drug: IFX-1
intravenously administered
Other Name: CaCP29

Drug: Glucocorticoid (GC)
orally administered
Other Name: Prednisone

Active Comparator: Group B Placebo + active comparator
Placebo-IFX-1 + standard dose GC
Drug: Placebo-IFX-1
intravenously administered
Other Name: Placebo

Drug: Glucocorticoid (GC)
orally administered
Other Name: Prednisone

Placebo Comparator: Group C Experimental + placebo comparator
IFX-1 + Placebo-GC
Drug: IFX-1
intravenously administered
Other Name: CaCP29

Drug: Placebo-Glucocorticoid (Placebo-GC)
orally administered
Other Name: Placebo

Primary Outcome Measures :
  1. 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 ]
    Efficacy Endpoint based on clinical response evaluated through BVAS.

Secondary Outcome Measures :
  1. Treatment-emergent adverse events (TEAE) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects who had a TEAE.

  2. Serious adverse events (SAEs) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects with SAEs

  3. Adverse Events of Special Interest (AESIs) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects with AESIs

  4. Glucocorticoid (GC)-induced toxicity of standard-dose GC and reduced-dose GC with IFX-1 treatment [ Time Frame: Week 24 ]
    Safety Endpoint: Glucocorticoid-induced toxicity as measured by the Glucocorticoid Toxicity Index

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03895801

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Sponsors and Collaborators
InflaRx GmbH
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Study Director: Anja Pfaff, PhD InflaRx GmbH
Principal Investigator: Peter A. Merkel, MD, MPH University of Pennsylvania
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Responsible Party: InflaRx GmbH Identifier: NCT03895801    
Other Study ID Numbers: IFX-1-P2.5
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by InflaRx GmbH:
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors