Trial · NCT03712345
Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
NCT03712345, Phase 2, Terminated, InflaRx GmbH; results first posted 2022-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA. Trials, record NCT03712345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03712345
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of IFX-1 in add-on to Standard of Care in GPA and MPA
- NCT number
- NCT03712345
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- InflaRx GmbH
- Conditions
- Granulomatosis With Polyangiitis (GPA), Microscopic Polyangiitis (MPA)
- Interventions
- IFX-1 low dose, IFX-1 high dose, Placebo
- First posted
- 2018-10-19
- Last updated
- 2022-05-26
- Results first posted
- 2022-05-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | Week 24 | Number and percentage of participants who experience at least one treatment-emergent adverse event (TEAE) per treatment group. |
| Secondary | Percentage of Participants Achieving Clinical Response | 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. |
| Secondary | Percentage of Participants With Clinical Remission (BVAS = 0) | Week 16 | Efficacy Endpoint that evaluates participants with complete remission |
| Secondary | IFX-1 Concentration Pre-dose | Week 16 | Assess the pharmacokinetic of the investigational medicinal product. |
| Secondary | 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 | 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 |
| Secondary | C5a Plasma Concentration | Week 16 | Pharmacodynamic parameter concentration |
| Secondary | IFX-1 Blocking Activity 2.5 nM | Week 16 | Pharmacodynamic Parameter of IFX-1 blocking activity 2.5 nM |
| Secondary | IFX-1 Blocking Activity 10 nM | Week 16 | Pharmacodynamic Parameter of IFX-1 blocking activity 10 nM |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | Week 24 | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Achieving Clinical Response | Week 16 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinical Remission (BVAS = 0) | Week 16 | Full Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | IFX-1 Concentration Pre-dose | Week 16 | Safety Analysis Set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | 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 | Weeks 1, 4 and 16 | Safety Analysis Set | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | C5a Plasma Concentration | Week 16 | Full Analysis Set | ng/mL | MEAN |
| SECONDARY | IFX-1 Blocking Activity 2.5 nM | Week 16 | Full Analysis Set | percentage of IFX-1 blocking activity | MEAN |
| SECONDARY | IFX-1 Blocking Activity 10 nM | Week 16 | Full Analysis Set | percentage of IFX-1 blocking activity | MEAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | IFX-1 High Dose | 6 | Participants | ||
| Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | IFX-1 Low Dose | 7 | Participants | ||
| Number and Percentage of Participants With at Least One TEAE Per Treatment Group. | Placebo | 5 | Participants | ||
| Percentage of Participants Achieving Clinical Response | IFX-1 High Dose | 5 | Participants | ||
| Percentage of Participants Achieving Clinical Response | IFX-1 Low Dose | 6 | Participants | ||
| Percentage of Participants Achieving Clinical Response | Placebo | 6 | Participants | ||
| Percentage of Participants With Clinical Remission (BVAS = 0) | IFX-1 High Dose | 3 | Participants | ||
| Percentage of Participants With Clinical Remission (BVAS = 0) | IFX-1 Low Dose | 6 | Participants | ||
| Percentage of Participants With Clinical Remission (BVAS = 0) | Placebo | 4 | Participants | ||
| IFX-1 Concentration Pre-dose | IFX-1 High Dose | 115598.80 | Geometric Coefficient of Variation 82.84 | ng/mL |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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 High Dose | 6 | |
| Overall Study | STARTED | IFX-1 Low Dose | 7 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | IFX-1 High Dose | 6 | |
| Overall Study | COMPLETED | IFX-1 Low Dose | 7 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | IFX-1 High Dose | 0 | |
| Overall Study | NOT COMPLETED | IFX-1 Low Dose | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events258
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 | Oral candidiasis | Infections and infestations | IFX-1 High Dose | 0 | 6 | 0 |
| other | Oral candidiasis | Infections and infestations | IFX-1 Low Dose | 0 | 7 | 0 |
| other | Oral candidiasis | Infections and infestations | Placebo | 2 | 6 | 2 |
| other | Upper respiratory tract infection | Infections and infestations | IFX-1 High Dose | 1 | 6 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | IFX-1 Low Dose | 1 | 7 | 1 |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 0 | 6 | 0 |
| other | Urinary tract infection | Infections and infestations | IFX-1 High Dose | 1 | 6 | 1 |
| other | Urinary tract infection | Infections and infestations | IFX-1 Low Dose | 0 | 7 | 0 |
| other | Urinary tract infection | Infections and infestations | Placebo | 1 | 6 | 1 |
| other | Labyrinthitis | Infections and infestations | IFX-1 High Dose | 0 | 6 | 0 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IFX-1 High Dose | 0 | 6 |
| Total, all-cause mortality | IFX-1 Low Dose | 0 | 7 |
| Total, all-cause mortality | Placebo | 0 | 6 |
| Total, other adverse events | IFX-1 High Dose | 6 | 6 |
| Total, other adverse events | IFX-1 Low Dose | 7 | 7 |
| Total, other adverse events | Placebo | 5 | 6 |
| Total, serious adverse events | IFX-1 High Dose | 2 | 6 |
| Total, serious adverse events | IFX-1 Low Dose | 1 | 7 |
| Total, serious adverse events | Placebo | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33164993 | DERIVED |
Source PubMed
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/NCT03712345
GET https://conductscience.org/api/trials/v1/NCT03712345/results?page=2