Trial record 4 of 10 for:
inflarx
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
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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. |
| ClinicalTrials.gov Identifier: NCT03712345 |
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Recruitment Status :
Terminated
(Due to COVID-19 pandemic outbreak and its impact on overall study activities. All efforts were made to ensure that participants that were enrolled and/or were still in the study will continue to receive treatment and follow-up until study completion.)
First Posted : October 19, 2018
Results First Posted : May 26, 2022
Last Update Posted : May 26, 2022
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Sponsor:
InflaRx GmbH
Collaborator:
Iqvia Pty Ltd
Information provided by (Responsible Party):
InflaRx GmbH
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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 low dose Drug: IFX-1 high dose Drug: Placebo | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 20 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 |
| Actual Primary Completion Date : | September 10, 2020 |
| Actual Study Completion Date : | May 3, 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Granulomatosis with polyangiitis
MedlinePlus related topics:
Granulomatosis with Polyangiitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: IFX-1 low dose
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
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Drug: IFX-1 low dose
Single IV infusions of IFX-1
Other Name: CaCP29 |
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Experimental: IFX-1 high dose
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
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Drug: IFX-1 high dose
Single IV infusions of IFX-1
Other Name: CaCP29 |
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Placebo Comparator: Placebo
Will receive placebo
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Drug: Placebo
Placebo |
Primary Outcome Measures :
- Number and Percentage of Participants With at Least One TEAE Per Treatment Group. [ Time Frame: Week 24 ]Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
Secondary Outcome Measures :
- Percentage of Participants Achieving Clinical Response [ Time Frame: Week 16 ]Efficacy Endpoint based on clinical response evaluated through BVAS. Clinical response is defined as a reduction in BVAS of ≥50% and no worsening in any body system and no administration of rescue medication prior to the response assessment.
- Percentage of Participants With Clinical Remission (BVAS = 0) [ Time Frame: Week 16 ]Efficacy Endpoint that evaluates participants with complete remission
- IFX-1 Concentration Pre-dose [ Time Frame: Week 16 ]Assess the pharmacokinetic of the investigational medicinal product.
- 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 Participants in the PK Substudy [ Time Frame: Weeks 1, 4 and 16 ]Analyze the IMP plasma concentration using a PK model: 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 participants in the PK substudy
- C5a Plasma Concentration [ Time Frame: Week 16 ]Pharmacodynamic parameter concentration
- IFX-1 Blocking Activity 2.5 nM [ Time Frame: Week 16 ]Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM
- IFX-1 Blocking Activity 10 nM [ Time Frame: Week 16 ]Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM
Information from the National Library of Medicine
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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:
- Male or female, ≥18 years of age.
- Diagnosis of GPA or MPA according to the definitions of the Chapel Hill Consensus Conference.
- 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.
- New or relapsed GPA or MPA that require treatment with CYC or RTX plus GCs.
Exclusion Criteria:
- Any other multisystem autoimmune disease
- Requires mechanical ventilation because of alveolar hemorrhage at Screening.
- 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.
- 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.
- Received more than 3 g cumulative high dose intravenous GCs within 4 weeks before Screening.
- On an oral dose of a GC of more than 10 mg prednisone equivalent at Screening or for more than 6 weeks before Screening.
- 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.
- Received a live vaccination within 4 weeks before Screening or planned between Screening and Week 24.
- 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
Locations
Show 38 study locations
Sponsors and Collaborators
InflaRx GmbH
Iqvia Pty Ltd
Investigators
| Study Director: | Korinna Pilz, MD, MS | InflaRx GmbH | |
| Principal Investigator: | Peter A. Merkel, MD, MPH | University of Pennsylvania |
Study Documents (Full-Text)
Documents provided by InflaRx GmbH:
Documents provided by InflaRx GmbH:
Study Protocol and Statistical Analysis Plan [PDF] March 25, 2019
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | InflaRx GmbH |
| ClinicalTrials.gov Identifier: | NCT03712345 |
| Other Study ID Numbers: |
IFX-1-P2.6 |
| First Posted: | October 19, 2018 Key Record Dates |
| Results First Posted: | May 26, 2022 |
| Last Update Posted: | May 26, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by InflaRx GmbH:
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Granulomatosis with Polyangiitis (GPA) Microscopic Polyangiitis (MPA) IFX-1 ANCA AAV |
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 Skin Diseases, Vascular Skin Diseases |
Autoimmune Diseases Immune System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vilobelimab Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |