A Phase 2 interventional study of IFX-1 and Placebo-IFX-1 in Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), sponsored by InflaRx GmbH. Completed at 76 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by InflaRx GmbH · Phase 2, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy of IFX-1 treatment as replacement for glucocorticoid (GC) therapy in subjects with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) is a group of potentially life-threatening autoimmune diseases. Preclinical data demonstrate that primed neutrophils are activated by anti-neutrophil cytoplasmic antibody (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 granulomatosis with GPA and MPA, IFX-1 will be administered in combination with reduced dose glucocorticoids or a placebo glucocorticoid compared with standard dose glucocorticoids.
104 studies on the registry are indexed under Granulomatosis with Polyangiitis; 16 are open to participants now.
This study's enrollment of 57 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
IFX-1 + reduced dose GC
Drug: IFX-1 · Drug: Glucocorticoid (GC)
Placebo-IFX-1 + standard dose GC
Drug: Placebo-IFX-1 · Drug: Glucocorticoid (GC)
IFX-1 + Placebo-GC
Drug: IFX-1 · Drug: Placebo-Glucocorticoid (Placebo-GC)
intravenously administered
Also known as: CaCP29
intravenously administered
Also known as: Placebo
orally administered
Also known as: Prednisone
orally administered
Also known as: Placebo
Percentage of Subjects Achieving Clinical Response
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
Time frame: Baseline, Week 16
Percentage of Subjects With Clinical Remission
Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
Time frame: Week 16
Change From Baseline in BVASv3 Total Score
Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3.
Time frame: Baseline, Week 16
Vasculitis Damage Index (VDI)
Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items.
Time frame: Week 16
Physician Global Assessment (PGA)
Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity;
Time frame: Week 16
Estimated Glomerular Filtration Rate
Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation: eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)
Time frame: Week 16
Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE)
Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE)
Time frame: Week 24
Glucocorticoid Toxicity Index (GTI)
Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in "Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis." by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al.
Time frame: Week 16
IFX-1 Plasma Concentrations (Pre-dose)
Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit.
Time frame: Week 16 (pre-dose)
Plasma Concentrations of C5a
Pharmacodynamics endpoint: Plasma concentrations of C5a
Time frame: Week 16
IFX-1 Blocking Activity 10 nM
Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM
Time frame: Week 16
IFX-1 Blocking Activity 2.5 nM
Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM
Time frame: Week 16
| Milestone | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Started | 18 | 24 | 15 |
| Completed | 16 | 22 | 13 |
| Not completed | 2 | 2 | 2 |
Efficacy Endpoint: Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score version 3 \[BVASv3\] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
| Participants | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Percentage of Subjects Achieving Clinical Response | 16 | 22 | 10 |
Efficacy endpoint: Percentage of subjects with clinical remission, defined as having a BVASv3 = 0. Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits. The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity.
| Participants | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Percentage of Subjects With Clinical Remission | 14 | 20 | 10 |
Efficacy endpoint: Absolute Change from baseline (= screening assessment) in Birmingham Vasculitis Activity Score version 3 (BVASv3) total score; The BVASv3 score ranges from 0 to 63 with higher values representing higher disease activity. The total score is derived by summing up item scores according to the scoring manual for the BVASv3.
| score on a scale | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Change From Baseline in BVASv3 Total Score | -13.8 ± 4.1 | -14.7 ± 5.9 | -16.6 ± 5.8 |
Efficacy endpoint: Absolute values of VDI; The VDI total score ranges from 0 to 64 with higher scores indicating more organ damage since the onset of vasculitis. The total score is the number of present damage items.
| score on a scale | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Vasculitis Damage Index (VDI) | 1.0 ± 1.0 | 1.5 ± 1.1 | 1.9 ± 1.8 |
Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity;
| score on a scale | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Physician Global Assessment (PGA) | 0.4 ± 1.0 | 0.1 ± 0.5 | 0.7 ± 1.8 |
Efficacy endpoint: Absolute values of estimated glomerular filtration rate (eGFR) in mL/min/1.73 m²; The eGFR was calculated by the central laboratory according to the Modified Diet in Renal Disease equation: eGFR = 175 x (serum creatinine, mg/dL)-1.154 x (age, years)-0.203 x (0.742 if female) x (1.212 if black)
| mL/min/1.73 m² | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Estimated Glomerular Filtration Rate | 50.2 ± 17.7 | 57.0 ± 22.8 | 51.2 ± 26.2 |
Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE)
| Participants | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) | 16 | 24 | 15 |
Safety endpoint: The GTI total score ranges from -35 to 410 (because the bone domain is excluded in this study) with higher score indicating greater Glucocorticoid toxicity. Scoring was performed in the electronic case report form according to the corresponding scoring manual in "Development of a Glucocorticoid Toxicity Index (GTI) using multicriteria decision analysis." by Miloslavsky EM, Naden RP, Bijlsma JW, Brogan PA, Brown ES, Brunetta P, et al.
| score on a scale | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Glucocorticoid Toxicity Index (GTI) | 0.8 ± 9.0 | 44.9 ± 41.5 | 26.1 ± 39.2 |
Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit.
| ng/mL | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| IFX-1 Plasma Concentrations (Pre-dose) | 67077.19 ± 77.33 | 47.80 ± 152.42 | 52597.85 ± 118.15 |
Pharmacodynamics endpoint: Plasma concentrations of C5a
| ng/mL | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Plasma Concentrations of C5a | 10.6816 ± 5.8505 | 39.2822 ± 25.6249 | 13.6320 ± 12.3040 |
Pharmacodynamics endpoint: IFX-1 blocking activity 10 nM
| percentage of IFX-1 blocking activity | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| IFX-1 Blocking Activity 10 nM | 100.571 ± 2.651 | — | 100.508 ± 10.051 |
Pharmacodynamics endpoint: IFX-1 blocking activity 2.5 nM
| percentage of IFX-1 blocking activity | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| IFX-1 Blocking Activity 2.5 nM | 98.260 ± 16.731 | — | 121.881 ± 59.979 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IFX-1 + Placebo-GC | 1/18 (5.6%) | 5/18 (27.8%) | 15/18 (83.3%) |
| Placebo-IFX-1 + Standard Dose GC | 0/24 (0%) | 4/24 (16.7%) | 23/24 (95.8%) |
| IFX-1 + Reduced Dose GC | 0/15 (0%) | 3/15 (20%) | 15/15 (100%) |
| Event | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/18 | 0/24 | 1/15 |
| PyrexiaGeneral disorders | 0/18 | 0/24 | 1/15 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/18 | 0/24 | 1/15 |
| Pneumocystis jirovecii pneumoniaInfections and infestations | 1/18 | 1/24 | 0/15 |
| Staphylococcal sepsisInfections and infestations | 1/18 | 0/24 | 0/15 |
| Acute myocardial infarctionCardiac disorders | 1/18 | 0/24 | 0/15 |
| Anti-neutrophil cytoplasmic antibody positive vasculitisImmune system disorders | 1/18 | 0/24 | 0/15 |
| Granulomatosis with polyangiitisVascular disorders | 1/18 | 0/24 | 0/15 |
| Pulmonary sepsisInfections and infestations | 0/18 | 1/24 | 0/15 |
| Condition aggravatedGeneral disorders | 0/18 | 1/24 | 0/15 |
| Event | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/18 | 6/24 | 5/15 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 1/18 | 6/24 | 1/15 |
| HypertensionVascular disorders | 2/18 | 6/24 | 2/15 |
| HeadacheNervous system disorders | 3/18 | 5/24 | 2/15 |
| Weight increasedInvestigations | 1/18 | 5/24 | 0/15 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 3/18 | 1/24 | 3/15 |
| Adverse drug reactionGeneral disorders | 0/18 | 1/24 | 3/15 |
| NauseaGastrointestinal disorders | 0/18 | 1/24 | 3/15 |
| FatigueGeneral disorders | 0/18 | 4/24 | 2/15 |
| Fat tissue increasedGeneral disorders | 1/18 | 4/24 | 0/15 |
| Age, Continuous(years) | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| Mean | 60.8 ± 11.4 | 55.0 ± 12.3 | 58.5 ± 14.0 | 57.8 ± 12.6 |
| Sex: Female, Male(Participants) | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| Female | 6 | 6 | 5 | 17 |
| Male | 12 | 18 | 10 | 40 |
| Ethnicity (NIH/OMB)(Participants) | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 0 | 1 |
| Not Hispanic or Latino | 17 | 24 | 15 | 56 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 18 | 24 | 15 | 57 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| AAV disease type(Participants) | IFX-1 + Placebo-GC | Placebo-IFX-1 + Standard Dose GC | IFX-1 + Reduced Dose GC | Total |
|---|---|---|---|---|
| Granulomatosis with polyangiitis (GPA) | 10 | 16 | 11 | 37 |
| Microscopic polyangiitis (MPA) | 8 | 8 | 4 | 20 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2019 to primary completion in Apr 2021, 24 months.
Results were first posted in Aug 2022, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Vilobelimab · Glucocorticoid
Granulomatosis with Polyangiitis →
InflaRx GmbH