Trial · NCT03895801
Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
NCT03895801, Phase 2, Completed, InflaRx GmbH; results first posted 2022-08-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis. Trials, record NCT03895801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03895801
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of IFX-1 to Replace Steroids in Patients With Granulomatosis With Polyangiitis and Microscopic Polyangiitis.
- NCT number
- NCT03895801
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- InflaRx GmbH
- Conditions
- Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
- Interventions
- IFX-1, Placebo-IFX-1, Glucocorticoid (GC), Placebo-Glucocorticoid (Placebo-GC)
- First posted
- 2019-03-29
- Last updated
- 2022-08-25
- Results first posted
- 2022-08-25
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects Achieving Clinical Response | Baseline, Week 16 | 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. |
| Secondary | Percentage of Subjects With Clinical Remission | Week 16 | 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. |
| Secondary | Change From Baseline in BVASv3 Total Score | Baseline, Week 16 | 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. |
| Secondary | Vasculitis Damage Index (VDI) | Week 16 | 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. |
| Secondary | Physician Global Assessment (PGA) | Week 16 | Efficacy endpoint: Absolute values in PGA; Physician global assessment scale: 0 = Remission to 10 = Maximum activity; |
| Secondary | Estimated Glomerular Filtration Rate | Week 16 | 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) |
| Secondary | Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) | Week 24 | Safety endpoint: Number and percentage of subjects who had a treatment-emergent adverse event (TEAE) |
| Secondary | Glucocorticoid Toxicity Index (GTI) | Week 16 | 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. |
| Secondary | IFX-1 Plasma Concentrations (Pre-dose) | Week 16 (pre-dose) | Pharmacokinetics endpoint: IFX-1 plasma concentrations assessed prior to study drug administration at corresponding visit. |
| Secondary | Plasma Concentrations of C5a | Week 16 | Pharmacodynamics endpoint: Plasma concentrations of C5a |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects Achieving Clinical Response | Baseline, Week 16 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Clinical Remission | Week 16 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in BVASv3 Total Score | Baseline, Week 16 | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Vasculitis Damage Index (VDI) | Week 16 | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Physician Global Assessment (PGA) | Week 16 | Full Analysis Set | score on a scale | MEAN |
| SECONDARY | Estimated Glomerular Filtration Rate | Week 16 | Full Analysis Set | mL/min/1.73 m² | MEAN |
| SECONDARY | Number and Percentage of Subjects Who Had a Treatment-emergent Adverse Event (TEAE) | Week 24 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Glucocorticoid Toxicity Index (GTI) | Week 16 | Safety Analysis Set (Data missing from 2 patients in IFX-1 + Placebo-GC group, from 2 patients in Placebo-IFX-1 + standard dose GC group, and from 3 patients in IFX-1 + reduced dose GC group) | score on a scale | MEAN |
| SECONDARY | IFX-1 Plasma Concentrations (Pre-dose) | Week 16 (pre-dose) | Safety Analysis Set (Data missing from 5 patients in IFX-1 + Placebo-GC group, from 7 patients in Placebo-IFX-1 + standard dose GC group, and from 7 patients in IFX-1 + reduced dose GC group) | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Concentrations of C5a | Week 16 | Full Analysis Set (Data missing from 4 patients in IFX-1 + Placebo-GC group, from 10 patients in Placebo-IFX-1 + standard dose GC group, and from 8 patients in IFX-1 + reduced dose GC group) | ng/mL | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group34
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects Achieving Clinical Response | IFX-1 + Placebo-GC | 16 | Participants | ||
| Percentage of Subjects Achieving Clinical Response | Placebo-IFX-1 + Standard Dose GC | 22 | Participants | ||
| Percentage of Subjects Achieving Clinical Response | IFX-1 + Reduced Dose GC | 10 | Participants | ||
| Percentage of Subjects With Clinical Remission | IFX-1 + Placebo-GC | 14 | Participants | ||
| Percentage of Subjects With Clinical Remission | Placebo-IFX-1 + Standard Dose GC | 20 | Participants | ||
| Percentage of Subjects With Clinical Remission | IFX-1 + Reduced Dose GC | 10 | Participants | ||
| Change From Baseline in BVASv3 Total Score | IFX-1 + Placebo-GC | -13.8 | Standard Deviation 4.1 | score on a scale | |
| Change From Baseline in BVASv3 Total Score | Placebo-IFX-1 + Standard Dose GC | -14.7 | Standard Deviation 5.9 | score on a scale | |
| Change From Baseline in BVASv3 Total Score | IFX-1 + Reduced Dose GC | -16.6 | Standard Deviation 5.8 | score on a scale | |
| Vasculitis Damage Index (VDI) | IFX-1 + Placebo-GC | 1.0 | Standard Deviation 1.0 | score on a scale |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IFX-1 + Placebo-GC | 18 | |
| Overall Study | STARTED | Placebo-IFX-1 + Standard Dose GC | 24 | |
| Overall Study | STARTED | IFX-1 + Reduced Dose GC | 15 | |
| Overall Study | COMPLETED | IFX-1 + Placebo-GC | 16 | |
| Overall Study | COMPLETED | Placebo-IFX-1 + Standard Dose GC | 22 | |
| Overall Study | COMPLETED | IFX-1 + Reduced Dose GC | 13 | |
| Overall Study | NOT COMPLETED | IFX-1 + Placebo-GC | 2 | |
| Overall Study | NOT COMPLETED | Placebo-IFX-1 + Standard Dose GC | 2 | |
| Overall Study | NOT COMPLETED | IFX-1 + Reduced Dose GC | 2 |
Source ClinicalTrials.gov
Adverse events582
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | IFX-1 + Placebo-GC | 1 | 18 | 1 |
| other | Nasopharyngitis | Infections and infestations | Placebo-IFX-1 + Standard Dose GC | 6 | 24 | 7 |
| other | Nasopharyngitis | Infections and infestations | IFX-1 + Reduced Dose GC | 5 | 15 | 6 |
| other | Pneumonia | Infections and infestations | IFX-1 + Placebo-GC | 0 | 18 | 0 |
| other | Pneumonia | Infections and infestations | Placebo-IFX-1 + Standard Dose GC | 3 | 24 | 3 |
| other | Pneumonia | Infections and infestations | IFX-1 + Reduced Dose GC | 0 | 15 | 0 |
| other | Urinary tract infection | Infections and infestations | IFX-1 + Placebo-GC | 1 | 18 | 1 |
| other | Urinary tract infection | Infections and infestations | Placebo-IFX-1 + Standard Dose GC | 2 | 24 | 2 |
| other | Urinary tract infection | Infections and infestations | IFX-1 + Reduced Dose GC | 0 | 15 | 0 |
| other | Cystitis | Infections and infestations | IFX-1 + Placebo-GC | 0 | 18 | 0 |
1 to 10 of 582Source ClinicalTrials.gov
See all 582 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IFX-1 + Placebo-GC | 1 | 18 |
| Total, all-cause mortality | Placebo-IFX-1 + Standard Dose GC | 0 | 24 |
| Total, all-cause mortality | IFX-1 + Reduced Dose GC | 0 | 15 |
| Total, other adverse events | IFX-1 + Placebo-GC | 15 | 18 |
| Total, other adverse events | Placebo-IFX-1 + Standard Dose GC | 23 | 24 |
| Total, other adverse events | IFX-1 + Reduced Dose GC | 15 | 15 |
| Total, serious adverse events | IFX-1 + Placebo-GC | 5 | 18 |
| Total, serious adverse events | Placebo-IFX-1 + Standard Dose GC | 4 | 24 |
| Total, serious adverse events | IFX-1 + Reduced Dose GC | 3 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03895801
GET https://conductscience.org/api/trials/v1/NCT03895801/results?page=2