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 |
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Recruitment Status :
Active, not recruiting
First Posted : March 29, 2019
Last Update Posted : January 12, 2021
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Sponsor:
InflaRx GmbH
Information provided by (Responsible Party):
InflaRx GmbH
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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 |
|---|---|---|
| Granulomatosis With Polyangiitis (GPA) Microscopic Polyangiitis (MPA) | Drug: IFX-1 Drug: Placebo-IFX-1 Drug: Glucocorticoid (GC) Drug: Placebo-Glucocorticoid (Placebo-GC) | Phase 2 |
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 55 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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 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 : | April 3, 2019 |
| Estimated Primary Completion Date : | April 2021 |
| Estimated Study Completion Date : | June 2021 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Granulomatosis with polyangiitis
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group A Experimental + active comparator
IFX-1 + reduced dose GC
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Drug: IFX-1
intravenously administered
Other Name: CaCP29 Drug: Glucocorticoid (GC) orally administered
Other Name: Prednisone |
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Active Comparator: Group B Placebo + active comparator
Placebo-IFX-1 + standard dose GC
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Drug: Placebo-IFX-1
intravenously administered
Other Name: Placebo Drug: Glucocorticoid (GC) orally administered
Other Name: Prednisone |
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Placebo Comparator: Group C Experimental + placebo comparator
IFX-1 + Placebo-GC
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Drug: IFX-1
intravenously administered
Other Name: CaCP29 Drug: Placebo-Glucocorticoid (Placebo-GC) orally administered
Other Name: Placebo |
Primary Outcome Measures :
- 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 :
- 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
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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 and/or any excipient.
- Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Have required management of infections, as follows (a) Chronic infection requiring anti-infective therapy within 3 months before screening. (b) Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days of screening
- Current and/or history (within the previous 5 years) of drug and/or alcohol abuse and/or dependence.
- Evidence of Hep B, C and/ or HIV infection. Only subjects with documented negative historical results (within 4 weeks before screening) for Hep B,C Virus and HIV or a negative test by Screening can be included into the study.
- Abnormal laboratory findings at screening
- Current or history of malignancy, lymphoproliferative, or myeloproliferative disorder
- Received CYC or RTX within 12 weeks before screening or within 12 weeks before CYC or RTX is started for remission induction within 2 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 an oral daily dose of a GC of > 80 mg prednisone equivalent within 2 weeks before screening.
- Received a CD20 inhibitor, anti-tumor necrosis factor treatment, abatacept, alemtuzumab, any other experimental or biological therapy, intravenous immunoglobulin (Ig) or plasma exchange, antithymocyte globulin, or required renal dialysis within 12 weeks before 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
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
Locations
Show 76 study locations
Sponsors and Collaborators
InflaRx GmbH
Investigators
| Study Director: | Anja Pfaff, PhD | InflaRx GmbH | |
| Principal Investigator: | Peter A. Merkel, MD, MPH | University of Pennsylvania |
| 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: | January 12, 2021 |
| Last Verified: | January 2021 |
| 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 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 Prednisone Glucocorticoids Anti-Inflammatory Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents |