A Phase 2 interventional study of IFX-1 low dose and IFX-1 high dose in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), sponsored by InflaRx GmbH. Terminated at 38 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-26.
Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment
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.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 20 is below the median of 70 across 69 interventional studies indexed under Granulomatosis with Polyangiitis.
Browse Granulomatosis with Polyangiitis studies →InflaRx GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Will receive IFX-1 low dose regimen diluted in sodium chloride solution
Drug: IFX-1 low dose
Will receive IFX-1 high dose regimen diluted in sodium chloride solution
Drug: IFX-1 high dose
Will receive placebo
Drug: Placebo
Single IV infusions of IFX-1
Also known as: CaCP29
Single IV infusions of IFX-1
Also known as: CaCP29
Placebo
Number and Percentage of Participants With at Least One TEAE Per Treatment Group.
Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
Time frame: Week 24
Percentage of Participants Achieving Clinical Response
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.
Time frame: Week 16
Percentage of Participants With Clinical Remission (BVAS = 0)
Efficacy Endpoint that evaluates participants with complete remission
Time frame: Week 16
IFX-1 Concentration Pre-dose
Assess the pharmacokinetic of the investigational medicinal product.
Time frame: Week 16
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
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
Time frame: Weeks 1, 4 and 16
C5a Plasma Concentration
Pharmacodynamic parameter concentration
Time frame: Week 16
IFX-1 Blocking Activity 2.5 nM
Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM
Time frame: Week 16
IFX-1 Blocking Activity 10 nM
Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM
Time frame: Week 16
| Milestone | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| Started | 6 | 7 | 7 |
| Completed | 6 | 7 | 6 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Failure to meet randomization criteria | 0 | 0 | 1 |
Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group.
| Participants | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | 6 | 7 | 5 |
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.
| Participants | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| Percentage of Participants Achieving Clinical Response | 5 | 6 | 6 |
Efficacy Endpoint that evaluates participants with complete remission
| Participants | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| Percentage of Participants With Clinical Remission (BVAS = 0) | 3 | 6 | 4 |
Assess the pharmacokinetic of the investigational medicinal product.
| ng/mL | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| IFX-1 Concentration Pre-dose | 115598.80 ± 82.84 | 7258.96 ± 45.57 | 38.09 ± 137.68 |
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
| ng/mL | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| 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 | NA ± NA | NA ± NA | NA ± NA |
Pharmacodynamic parameter concentration
| ng/mL | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| C5a Plasma Concentration | 9.4475 ± 7.9414 | 37.1361 ± 9.7106 | 31.6571 ± 6.9818 |
Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM
| percentage of IFX-1 blocking activity | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| IFX-1 Blocking Activity 2.5 nM | 103.873 ± 4.667 | 82.383 ± 21.957 | — |
Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM
| percentage of IFX-1 blocking activity | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| IFX-1 Blocking Activity 10 nM | 101.693 ± 0.771 | 60.473 ± 29.531 | — |
Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IFX-1 High Dose | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| IFX-1 Low Dose | 0/7 (0%) | 1/7 (14.3%) | 7/7 (100%) |
| Placebo | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Event | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 1/6 | 0/7 | 0/6 |
| Atrial fibrillationCardiac disorders | 1/6 | 1/7 | 0/6 |
| Myocardial infarctionCardiac disorders | 1/6 | 0/7 | 0/6 |
| AnaemiaBlood and lymphatic system disorders | 1/6 | 0/7 | 0/6 |
| AstheniaGeneral disorders | 1/6 | 0/7 | 0/6 |
| Troponin increasedInvestigations | 1/6 | 0/7 | 0/6 |
| Acute kidney injuryRenal and urinary disorders | 1/6 | 0/7 | 0/6 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/6 | 0/7 | 0/6 |
| Deep vein thrombosisVascular disorders | 1/6 | 0/7 | 0/6 |
| Event | IFX-1 High Dose | IFX-1 Low Dose | Placebo |
|---|---|---|---|
| Oral candidiasisInfections and infestations | 0/6 | 0/7 | 2/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/6 | 0/7 | 1/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/6 | 0/7 | 0/6 |
| HeadacheNervous system disorders | 1/6 | 2/7 | 0/6 |
| Hot flushVascular disorders | 0/6 | 2/7 | 0/6 |
| Vision blurredEye disorders | 0/6 | 2/7 | 1/6 |
| Upper respiratory tract infectionInfections and infestations | 1/6 | 1/7 | 0/6 |
| Urinary tract infectionInfections and infestations | 1/6 | 0/7 | 1/6 |
| Oropharyngeal candidiasisInfections and infestations | 0/6 | 0/7 | 1/6 |
| Otitis media acuteInfections and infestations | 1/6 | 0/7 | 0/6 |
Safety Analysis Set
| Age, Continuous(years) | IFX-1 Low Dose | IFX-1 High Dose | Placebo | Total |
|---|---|---|---|---|
| Mean | 65.0 ± 15.1 | 54.8 ± 12.0 | 56.5 ± 16.2 | 59.1 ± 14.5 |
| Sex: Female, Male(Participants) | IFX-1 Low Dose | IFX-1 High Dose | Placebo | Total |
|---|---|---|---|---|
| Female | 5 | 5 | 3 | 13 |
| Male | 2 | 1 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | IFX-1 Low Dose | IFX-1 High Dose | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 1 | 4 |
| Not Hispanic or Latino | 6 | 4 | 5 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | IFX-1 Low Dose | IFX-1 High Dose | Placebo | Total |
|---|---|---|---|---|
| White | 4 | 5 | 5 | 14 |
| Asian | 1 | 0 | 0 | 1 |
| Multiple | 1 | 0 | 0 | 1 |
| Other | 1 | 1 | 1 | 3 |
| AAV disease type(Participants) | IFX-1 Low Dose | IFX-1 High Dose | Placebo | Total |
|---|---|---|---|---|
| GPA | 5 | 4 | 4 | 13 |
| MPA | 2 | 2 | 2 | 6 |
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Studies of the drug tested here: Vilobelimab
Granulomatosis with Polyangiitis →
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