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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:October 15, 2018
End Date:June 30, 2020
Contact:Othmar Zenker, MD
Email:clinicaltrials@inflarx.de
Phone:+49-(0) 3641-508 180

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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)

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.

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.

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).
We found this trial at
19
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Albuquerque, New Mexico 87131
(505) 277-0111
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Camp Hill, Pennsylvania 17011
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Corpus Christi, Texas 78404
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Dallas, Texas 76034
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Duncansville, Pennsylvania 16635
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101 3rd Avenue Southwest
Minot, North Dakota 58701
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New Hyde Park, New York 11042
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535 E 70th St
New York, New York 10021
(212) 606-1000
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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North Charleston, South Carolina 29406
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
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