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Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)

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ClinicalTrials.gov Identifier: NCT03712345
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
IQVIA
Information provided by (Responsible Party):
InflaRx GmbH

Brief Summary:
The purpose of this study is to investigate the safety and tolerability of two dose regimens of IFX-1 as add-on to standard of care (SOC) in subjects with GPA and MPA compared with placebo.

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

Detailed Description:

Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are related systemic v anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a potentially life-threatening disease.

GPA is a necrotizing vasculitis predominantly involving small- to medium-sized vessels (e.g., capillaries, venules, arterioles, arteries, and veins). MPA is a necrotizing vasculitis that primarily affects capillaries, venules, or arterioles, most commonly manifesting as necrotizing glomerulonephritis and/or pulmonary capillaritis. MPA.

Primed neutrophils are activated by ANCA and generate C5a that engages C5a receptors on neutrophils. Therefore, patients with ANCA-related disease have elevated plasma and urine levels of C5a in active disease and not in remission.

IFX-1 is a monoclonal antibody specifically binding to the soluble human complement split product C5a and the resulting nearly complete blockade of C5a-induced biological effects may be effective in the treatment of subjects with AAV.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase II Efficacy and Safety Study of IFX-1 in Add-On to Standard of Care in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA)
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020


Arm Intervention/treatment
Experimental: Group A
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
Drug: IFX-1
Single IV infusions of IFX-1
Other Name: CaCP29

Experimental: Group B
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
Drug: IFX-1
Single IV infusions of IFX-1
Other Name: CaCP29

Placebo Comparator: Group C
Will receive placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Number and percentage of subjects who experience at least one treatment-emergent adverse event (TEAE) per treatment group. [ Time Frame: Week 24 ]
    Safety parameters will be evaluated (number of total TEAEs)


Secondary Outcome Measures :
  1. Proportion of subjects achieving clinical response (reduction in BVAS of ≥50% and no worsening in any body system) [ Time Frame: Week 16 ]
    Efficacy Endpoint based on clinical response evaluated through BVAS.

  2. Proportion of subjects with clinical remission (BVAS = 0) [ Time Frame: Week 16 ]
    Efficacy Endpoint that evaluates subjects with complete remission

  3. IFX 1 concentration pre- and postdose at each IMP administration visit [ Time Frame: Week 0 to Week 16, Week 20 and Week 24 ]
    Assess the pharmacokinetic of the investigational medicinal product.

  4. IFX 1 concentration at predose (0 hours), after the end of the infusion (+10minutes), and at 2, 6, 24, and 48 hours after the start of the infusion for subjects in the PK substudy [ Time Frame: Weeks 1, 4 and 16 ]
    Analyze the IMP plasma concentration using a PK model.



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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:

  1. Male or female, ≥18 years of age.
  2. Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference.
  3. Have at least one "major" item, or at least three other items, or at least two renal items on the Birmingham Vasculitis Activity Score (BVAS) Version 3.0.
  4. New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.

Exclusion Criteria:

  1. Any other multisystem autoimmune disease
  2. Requires mechanical ventilation because of alveolar hemorrhage at Screening.
  3. Human immunodeficiency virus, hepatitis B, or hepatitis C viral screening test showing evidence of active or chronic viral infection at Screening or a documented history of the human immunodeficiency virus, hepatitis B, or hepatitis C.
  4. Received CYC or RTX 12 weeks before Screening; if on azathioprine (AZA), methotrexate (MTX), mycophenolate mofetil (MMF), or mycophenolate sodium (MPS) at the time of Screening, these drugs must be withdrawn prior to receiving CYC or RTX.
  5. Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before Screening.
  6. On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for more than 6 weeks before Screening.
  7. Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin or plasma exchange, antithymocyte globulin, or required dialysis within 12 weeks before Screening.
  8. Received a live vaccination within 4 weeks before Screening or planned between Screening and Week 24.
  9. Female subjects of childbearing potential unwilling or unable to use a highly effective method of contraception (pearl index <1%) such as complete sexual abstinence, combined oral contraceptive, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant, or depot contraceptive injection in combination with a second method of contraception such as condom, cervical cap, or diaphragm with spermicide during the study and for at least 4 weeks after last administration of IFX-1 (timeframes for SOC have to be considered as described in the respective Prescribing Information).

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): NCT03712345


Contacts
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Contact: Othmar Zenker, MD +49-(0) 3641-508 180 clinicaltrials@inflarx.de

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
United States, New York
Northwell Health, LLC PRIME Recruiting
New Hyde Park, New York, United States, 11042
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
University of Rochester Medical Center - Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
UNC Kidney Center, UNC-CH Division of Nephrology and Hypertension Recruiting
Chapel Hill, North Carolina, United States, 27599-7155
United States, North Dakota
Trinity Medical Group Recruiting
Minot, North Dakota, United States, 58701
United States, Ohio
Ohio State University Clinical Trials Management Office Recruiting
Columbus, Ohio, United States, 43203
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
BRCR Medical Center, Inc. Recruiting
Camp Hill, Pennsylvania, United States, 17011
Altoona Center for Clinical Research, P.C. Recruiting
Duncansville, Pennsylvania, United States, 16635
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Low Country Rheumatology, PA Recruiting
North Charleston, South Carolina, United States, 29406
United States, Texas
Adriana Pop Moody Clinic PA Recruiting
Corpus Christi, Texas, United States, 78404
Texas Health Resources Recruiting
Dallas, Texas, United States, 76034-5913
Sponsors and Collaborators
InflaRx GmbH
IQVIA
Investigators
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Study Director: Othmar Zenker InflaRx GmbH
Principal Investigator: Peter A. Merkel, MD, MPH University of Pennsylvania

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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT03712345     History of Changes
Other Study ID Numbers: IFX-1-P2.6
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 with Polyangiitis (GPA)
Microscopic Polyangiitis (MPA)
IFS-1
ANCA
AAV

Additional relevant MeSH terms:
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Systemic Vasculitis
Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases