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

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ClinicalTrials.gov Identifier: NCT03895801
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Study Description
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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
Polyangiitis, Granulomatosis With 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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 81 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 : March 22, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
  • Have required management of infections within 30 days of screening.
  • Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
  • Hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV)
  • Abnormal laboratory findings at screening
  • Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder
  • Received CYC or RTX within 12 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 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03895801


Contacts
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Contact: Othmar Zenker, MD +49 3641 508193 info@inflarx.de
Contact: Zenker info@inflarx.de

Locations
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Sponsors and Collaborators
InflaRx GmbH
Investigators
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Study Director: Othmar Zenker, MD InflaRx GmbH
More Information
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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT03895801    
Other Study ID Numbers: IFX-1-P2.5
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: September 2019

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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:
granulomatosis
polyangiitis
corticosteroid
replacement
glucocorticoid
Additional relevant MeSH terms:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Systemic Vasculitis
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs