Trial · NCT03971643
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
NCT03971643, Phase 2, Completed, InflaRx GmbH; results first posted 2023-09-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum. Trials, record NCT03971643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03971643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
- NCT number
- NCT03971643
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- InflaRx GmbH
- Conditions
- Pyoderma Gangrenosum
- Interventions
- vilobelimab
- First posted
- 2019-06-03
- Last updated
- 2023-09-14
- Results first posted
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | From treatment start until end of study (including observational visits), an average of 249 days | Number of patients with treatment-emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest (AESIs) TEAEs are defined as adverse events that start at or after the first administration of study drug. Related TEAEs are defined as all TEAEs considered by the investigator to have at least a 'possible' relationship with the study drug. AESIs are defined as infusion-related reactions, including acute and delayed hypersensitivity and anaphylactic reactions during or after infusion; Meningitis; Meningococcal septicaemia; Invasive infection. As adverse events will be reported in details in the safety section, no separate reporting on System Organ Class (SOC) or Preferred Term (PT) level etc. is done here. |
| Secondary | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | From treatment start until V16 (Day 189) | Efficacy endpoint: Proportion of patients with a clinical response, defined as Physician's Global Assessment (PGA) score ≤3 of target ulcer at Visit V4, V6, V10 and V16 (End of Treatment \[EOT\]) (SAF). PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse |
| Secondary | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | From treatment start until end of study (including observational visits), an average of 249 days | Efficacy endpoint: Kaplan-Meier analysis of time to first clinical remission (complete closure of target ulcer) defined as PGA score of ≤ 1, PGA values: 0 = Completely clear, 1 = Almost clear, 2 =Marked improvement, 3 = Moderate improvement, 4 = Slight improvement, 5 = No change from baseline, 6 = Worse |
| Secondary | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change in wound area \[percent change\] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. |
| Secondary | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | From treatment start until V16 (Day 189) | Efficacy endpoint: Percentage change in wound volume \[percent change\] of target ulcer by photographic assessment between Visits V1 and V4, between Visits V1 and V6, between Visits V1 and V16, between Visits V6 and V10, between Visits V10 and V16. |
| Secondary | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Rate of change per day in area of target ulcer \[mm²/day\] between Visits V1 and V16 (photographic assessment) |
| Secondary | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of ≥ 50% by photographic assessment at Visit V16 (EOT) compared to Baseline |
| Secondary | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Number of patients with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to Baseline (remission) (photographic assessment) |
| Secondary | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment) |
| Secondary | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment) |
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 | Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | From treatment start until end of study (including observational visits), an average of 249 days | Safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment) | From treatment start until V16 (Day 189) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days] | From treatment start until end of study (including observational visits), an average of 249 days | Safety Set | days | MEDIAN |
| SECONDARY | Percentage Change in Wound Healing (Wound Area) by Photographic Assessment | From treatment start until V16 (Day 189) | Safety Set~Only patients with an available wound area measurement at both relevant visits are included in the respective analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | percent change | MEAN |
| SECONDARY | Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment | From treatment start until V16 (Day 189) | Safety Set~Only patients with an available wound volume measurement at both relevant visits are included in the respective analysis. Wound volume for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. Additionally, sometimes the pictures allowed to measure the wound area, but not the volume as several pictures had to be taken to estimate the volume adequately. | percent change | MEAN |
| SECONDARY | Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16 | From treatment start until V16 (Day 189) | Safety Set~Only patients with an available wound area measurement at both relevant visits (V1 and V16) are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | mm²/day | MEAN |
| SECONDARY | Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16 | From treatment start until V16 (Day 189) | Safety Set~Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients With 100% Decrease in Area of Target Ulcer at V16 | From treatment start until V16 (Day 189) | Safety Set~Only patients with an available wound area measurement at baseline and V16 are included in this analysis. Wound area for single visits was missing because images were not taken correctly and the measurements could not be obtained or patients discontinued the study prior to the relevant visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Safety set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16 | From treatment start until V16 (Day 189) | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 800 mg Q2W | Treatment-emergent adverse events (TEAEs) | 6 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 1600 mg Q2W | Treatment-emergent adverse events (TEAEs) | 4 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 2400 mg Q2W | Treatment-emergent adverse events (TEAEs) | 5 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 800 mg Q2W | Related TEAEs | 0 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 1600 mg Q2W | Related TEAEs | 2 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 2400 mg Q2W | Related TEAEs | 2 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 800 mg Q2W | Serious TEAEs | 1 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 1600 mg Q2W | Serious TEAEs | 1 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 2400 mg Q2W | Serious TEAEs | 2 | Participants | |
| Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) | Vilobelimab 800 mg Q2W | Adverse events of special interest (AESIs) as identified by investigator | 0 | Participants |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vilobelimab 800 mg Q2W | 6 | |
| Overall Study | STARTED | Vilobelimab 1600 mg Q2W | 6 | |
| Overall Study | STARTED | Vilobelimab 2400 mg Q2W | 7 | |
| Overall Study | Completed Until Day 99 (Evaluable) | Vilobelimab 800 mg Q2W | 6 | |
| Overall Study | Completed Until Day 99 (Evaluable) | Vilobelimab 1600 mg Q2W | 4 | |
| Overall Study | Completed Until Day 99 (Evaluable) | Vilobelimab 2400 mg Q2W | 7 | |
| Overall Study | COMPLETED | Vilobelimab 800 mg Q2W | 1 | |
| Overall Study | COMPLETED | Vilobelimab 1600 mg Q2W | 3 | |
| Overall Study | COMPLETED | Vilobelimab 2400 mg Q2W | 6 | |
| Overall Study | NOT COMPLETED | Vilobelimab 800 mg Q2W | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events138
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 | Wound infection | Infections and infestations | Vilobelimab 800 mg Q2W | 2 | 6 | 3 |
| other | Wound infection | Infections and infestations | Vilobelimab 1600 mg Q2W | 1 | 6 | 1 |
| other | Wound infection | Infections and infestations | Vilobelimab 2400 mg Q2W | 0 | 7 | 0 |
| other | Wound infection pseudomonas | Infections and infestations | Vilobelimab 800 mg Q2W | 2 | 6 | 2 |
| other | Wound infection pseudomonas | Infections and infestations | Vilobelimab 1600 mg Q2W | 0 | 6 | 0 |
| other | Wound infection pseudomonas | Infections and infestations | Vilobelimab 2400 mg Q2W | 0 | 7 | 0 |
| other | Abscess limb | Infections and infestations | Vilobelimab 800 mg Q2W | 0 | 6 | 0 |
| other | Abscess limb | Infections and infestations | Vilobelimab 1600 mg Q2W | 0 | 6 | 0 |
| other | Abscess limb | Infections and infestations | Vilobelimab 2400 mg Q2W | 1 | 7 | 1 |
| other | Cellulitis | Infections and infestations | Vilobelimab 800 mg Q2W | 1 | 6 | 1 |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vilobelimab 800 mg Q2W | 0 | 6 |
| Total, all-cause mortality | Vilobelimab 1600 mg Q2W | 0 | 6 |
| Total, all-cause mortality | Vilobelimab 2400 mg Q2W | 0 | 7 |
| Total, other adverse events | Vilobelimab 800 mg Q2W | 6 | 6 |
| Total, other adverse events | Vilobelimab 1600 mg Q2W | 3 | 6 |
| Total, other adverse events | Vilobelimab 2400 mg Q2W | 5 | 7 |
| Total, serious adverse events | Vilobelimab 800 mg Q2W | 1 | 6 |
| Total, serious adverse events | Vilobelimab 1600 mg Q2W | 1 | 6 |
| Total, serious adverse events | Vilobelimab 2400 mg Q2W | 2 | 7 |
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03971643
GET https://conductscience.org/api/trials/v1/NCT03971643/results?page=2