Pyoderma GangrenosumPhase 2NCT03971643
Exploratory Study of IFX-1 in Patients With Pyoderma Gangrenosum
A Phase 2 study testing vilobelimab in people with Pyoderma Gangrenosum, run by InflaRx GmbH at 10 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pyoderma Gangrenosum
- What is being tested?
- vilobelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 10 sitesin 3 countries
- Study dates
- 16 May 2019to 3 Jan 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator
- In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:
- History of
- Pathergy (ulcer occurring at the sites of trauma)
- Personal history of inflammatory bowel disease or inflammatory arthritis
- History of papule, pustule or vesicle that rapidly ulcerated
Show all 11Show fewer
- Clinical examination (or photographic evidence) of
- Peripheral erythema, undermining border, and tenderness at site of ulceration
- Multiple ulcerations (at least 1 occurring on the lower leg)
- Cribriform or "wrinkled paper" scar(s) at sites of healed ulcers
- Subject has a minimum of 1 evaluable ulcer (≥2 cm2) on the lower extremity at screening
Who cannot join
- Pyoderma gangrenosum target ulcer for more than 3 years before screening
- Surgical wound debridement within the previous 2 weeks before screening
- Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
- Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
United States7 sites
InflaRx Site #05
Columbus, Ohio, 43210
InflaRx Site #12
Hershey, Pennsylvania, 17033
InflaRx Site #08
Miami, Florida, 33125
InflaRx Site #09
Pittsburgh, Pennsylvania, 15213
InflaRx Site #07
Sacramento, California, 95816
InflaRx Site #10
St Louis, Missouri, 63110
InflaRx Site #03
Tampa, Florida, 33613
About this study
Official title: Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Read the detailed description
Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
- Conditions
- Pyoderma Gangrenosum
- Being tested
- vilobelimab
- Medical subject headings
- Pyoderma Gangrenosum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vilobelimabDrug
Also called IFX-1, CaCP29
IV infusions of vilobelimab diluted in sodium chloride.
| Study group | Role | What they receive |
|---|---|---|
| vilobelimab 800 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab.
Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride.
All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8).
Starting at Day 15:
Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. Receives: Drug: vilobelimab |
| vilobelimab 1600 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab.
Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride.
All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8).
Starting at Day 15:
Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. Receives: Drug: vilobelimab |
| vilobelimab 2400 mg Q2W | Experimental | Dose finding with a total of 15 doses of vilobelimab.
Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride.
All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8).
Starting at Day 15:
Group 3 (N=7) received vilobelimab 2400 mg every Q2W. Receives: Drug: vilobelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)
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.
Measured: From treatment start until end of study (including observational visits), an average of 249 days
Secondary outcomes (11)
Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment)
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
Measured: From treatment start until V16 (Day 189)
Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [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
Measured: From treatment start until end of study (including observational visits), an average of 249 days
Percentage Change in Wound Healing (Wound Area) by Photographic Assessment
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.
Measured: From treatment start until V16 (Day 189)
Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment
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.
Measured: From treatment start until V16 (Day 189)
Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16
Efficacy endpoint: Rate of change per day in area of target ulcer [mm²/day] between Visits V1 and V16 (photographic assessment)
Measured: From treatment start until V16 (Day 189)
Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16
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
Measured: From treatment start until V16 (Day 189)
Number of Patients With 100% Decrease in Area of Target Ulcer at V16
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)
Measured: From treatment start until V16 (Day 189)
Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16
Efficacy endpoint: Degree of erythema of the target ulcer at Visit V4, V6, V10 and V16 (EOT) (investigator assessment)
Measured: From treatment start until V16 (Day 189)
Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16
Efficacy endpoint: Border elevation of the target ulcer at visits V4, V6, V10 and V16 (EOT) (investigator assessment)
Measured: From treatment start until V16 (Day 189)
Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16
Efficacy endpoint: Percentage change from Baseline in pain assessed by Numeric Rating Scale (NRS) [percent change] at visits V4, V6, V10 and V16 (EOT) Mean (SD)
The NRS is an 11-point scale (from 0 represent no pain to 10 representing the worst pain the subject can imagine).
Measured: From treatment start until V16 (Day 189)
Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16
Efficacy endpoint: Percentage change from Baseline in Dermatology Life Quality Index (DLQI) [percent change] at visits V4, V6, V10, and V16 (EOT)
The DLQI comprises 10 questions with single scores 0 (No effect on patient's life) to 3 (large effect on patient's life). The DLQI total score is calculated by summing up the score of each question resulting in a minimum of 0 (best) and a maximum of 30 (worst).
Measured: From treatment start until V16 (Day 189)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start16 May 2019
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- IV infusions of vilobelimab diluted in sodium chloride
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- InflaRx GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Responsible party
- Sponsor
- Investigators
- Prof. Niels C. Riedemann, M.D., Ph.D., Study director, InflaRx GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971643
- Sponsor's protocol ID
- IFX-1-P2.7
- Status last verified
- Sep 2023
- First submitted
- 28 May 2019
- Last updated
- 14 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)
- ClinicalTrials.gov ID
- NCT03971643
- Acronym / sponsor ID
- IFX-1-P2.7
- Conditions
- Pyoderma Gangrenosum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- InflaRx GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Innovaderm Research Inc.
- Study start
- 16 May 2019 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Posted 14 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Detailed description
Neutrophilic dermatoses are a spectrum of inflammatory disorders characterized by skin lesions resulting from a neutrophil-rich inflammatory infiltrate in the absence of infection. Pyoderma gangrenosum is associated with a neutrophilic leukocytosis, which is likely to be triggered by C5a. This study is set up based on the hypothesis that vilobelimab might be able to block C5a induced pro-inflammatory effects such as neutrophil activation and cytokine generation, potentially contributing to the local skin inflammation and tissue damage.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- IV infusions of vilobelimab diluted in sodium chloride
| Arm | Type | Receives |
|---|---|---|
| vilobelimab 800 mg Q2W | Experimental | Drug: vilobelimabDose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 1 (N=6) continued to receive vilobelimab 800 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 1600 mg every Q2W. |
| vilobelimab 1600 mg Q2W | Experimental | Drug: vilobelimabDose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 2 (N=6) received vilobelimab 1600 mg every 2 weeks (Q2W), with option to increase dose from Day 57 to 2400 mg every Q2W. |
| vilobelimab 2400 mg Q2W | Experimental | Drug: vilobelimabDose finding with a total of 15 doses of vilobelimab. Vilobelimab: IV infusions of vilobelimab diluted in sodium chloride. All patients received vilobelimab 800 mg three times during the first week (Days 1, 4, and 8). Starting at Day 15: Group 3 (N=7) received vilobelimab 2400 mg every Q2W. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator
- In addition, the subject must fulfill at least 3 of the following 6 criteria at screening:
- History of
- Pathergy (ulcer occurring at the sites of trauma)
- Personal history of inflammatory bowel disease or inflammatory arthritis
Key exclusion criteria (4 listed)
- Pyoderma gangrenosum target ulcer for more than 3 years before screening
- Surgical wound debridement within the previous 2 weeks before screening
- Use of intravenous antibacterials, antivirals, anti-fungals, or anti-parasitic agents within 30 days before screening
- Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg), intralesional steroids, cyclosporine A, biologicals and immunosuppressives (with the exception of antibiotics for wound superinfection) used within a time of 5 half-lives of the drug before screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vilobelimabAlso: IFX-1, CaCP29IV infusions of vilobelimab diluted in sodium chloride. | Drug | vilobelimab 1600 mg Q2W, vilobelimab 2400 mg Q2W, vilobelimab 800 mg Q2W |
Primary outcome
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs)
Time frame: 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.
11 secondary outcomes
Number of Patients With Physician's Global Assessment (PGA) Score ≤3 (Investigator Assessment)
Time frame: From treatment start until V16 (Day 189)
Time to Complete Closure of Pyoderma Gangrenosum Target Ulcer (Investigator Assessment) [Days]
Time frame: From treatment start until end of study (including observational visits), an average of 249 days
Percentage Change in Wound Healing (Wound Area) by Photographic Assessment
Time frame: From treatment start until V16 (Day 189)
Percentage Change in Wound Healing (Wound Volume) by Photographic Assessment
Time frame: From treatment start until V16 (Day 189)
Rate of Change Per Day in Area of Target Ulcer by Photographic Assessment From V1 to V16
Time frame: From treatment start until V16 (Day 189)
Number of Patients With ≥ 50% Decrease in Area of Target Ulcer by Photographic Assessment at V16
Time frame: From treatment start until V16 (Day 189)
Number of Patients With 100% Decrease in Area of Target Ulcer at V16
Time frame: From treatment start until V16 (Day 189)
Degree of Erythema of the Target Ulcer at V4, V6, V10 and V16
Time frame: From treatment start until V16 (Day 189)
Border Elevation of the Target Ulcer at Visits V4, V6, V10 and V16
Time frame: From treatment start until V16 (Day 189)
Percentage Change in Pain by Numeric Rating Scale (NRS) at Visits V4, V6, V10 and V16
Time frame: From treatment start until V16 (Day 189)
Percentage Change in Life Quality by DLQI at Visits V4, V6, V10, and V16
Time frame: From treatment start until V16 (Day 189)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Niels C. Riedemann, M.D., Ph.D. study director
InflaRx GmbH
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing vilobelimab in people with Pyoderma Gangrenosum, run by InflaRx GmbH at 10 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Poland, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent Adverse Events (TEAEs), Related TEAEs, Serious TEAEs, and Adverse Events of Special Interest (AESIs) (time frame: From treatment start until end of study (including observational visits), an average of 249 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.