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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 : June 6, 2019
Sponsor:
Collaborator:
IQVIA
Information provided by (Responsible Party):
InflaRx GmbH

Tracking Information
First Submitted Date  ICMJE March 8, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date June 6, 2019
Actual Study Start Date  ICMJE March 22, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03895801 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Treatment-emergent adverse events (TEAE) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects who had a TEAE.
  • Serious adverse events (SAEs) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects with SAEs
  • Adverse Events of Special Interest (AESIs) [ Time Frame: Week 24 ]
    Safety endpoint: Number and percentage of subjects with AESIs
  • 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
  • Pharmacokinetic and pharmacodynamic modelling of IFX-1 treatment [ Time Frame: Week 24 ]
    Plasma concentration of IFX-1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polyangiitis, Granulomatosis With
Intervention  ICMJE
  • Drug: IFX-1
    intravenously administered
    Other Name: CaCP29
  • Drug: Placebo-IFX-1
    intravenously administered
    Other Name: Placebo
  • Drug: Glucocorticoid (GC)
    orally administered
    Other Name: Prednisone
  • Drug: Placebo-Glucocorticoid (Placebo-GC)
    orally administered
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: Group A Experimental + active comparator
    IFX-1 + reduced dose GC
    Interventions:
    • Drug: IFX-1
    • Drug: Glucocorticoid (GC)
  • Active Comparator: Group B Placebo + active comparator
    Placebo-IFX-1 + standard dose GC
    Interventions:
    • Drug: Placebo-IFX-1
    • Drug: Glucocorticoid (GC)
  • Placebo Comparator: Group C Experimental + placebo comparator
    IFX-1 + Placebo-GC
    Interventions:
    • Drug: IFX-1
    • Drug: Placebo-Glucocorticoid (Placebo-GC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2019)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Othmar Zenker, MD +49 3641 508193 info@inflarx.de
Contact: Zenker info@inflarx.de
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03895801
Other Study ID Numbers  ICMJE IFX-1-P2.5
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InflaRx GmbH
Study Sponsor  ICMJE InflaRx GmbH
Collaborators  ICMJE IQVIA
Investigators  ICMJE
Study Director: Othmar Zenker, MD InflaRx GmbH
PRS Account InflaRx GmbH
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP