Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05964413




Registration number
NCT05964413
Ethics application status
Date submitted
29/06/2023
Date registered
27/07/2023
Date last updated
17/05/2024

Titles & IDs
Public title
Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in Ulcerative Pyoderma Gangrenosum
Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Adaptive Phase III Trial to Investigate Efficacy and Safety of Vilobelimab in the Treatment of Ulcerative Pyoderma Gangrenosum
Secondary ID [1] 0 0
IFX-1-P3.4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pyoderma Gangrenosum 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vilobelimab
Treatment: Drugs - Placebo

Experimental: vilobelimab - Patients will be treated with vilobelimab IV, Q2W for 26 weeks

Placebo Comparator: Placebo - Patients will receive placebo IV in the same schedule as patients in Arm 1


Treatment: Drugs: vilobelimab
vilobelimab infusion

Treatment: Drugs: Placebo
Placebo Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of treatment with vilobelimab compared to placebo
Timepoint [1] 0 0
Week 1 to Week 26
Secondary outcome [1] 0 0
Efficacy of treatment with vilobelimab compared to placebo
Timepoint [1] 0 0
2 weeks between study visits
Secondary outcome [2] 0 0
Pain reduction
Timepoint [2] 0 0
Week 10 through study completion

Eligibility
Key inclusion criteria
Main

1. 18 years or older at the time of signing the informed consent.

2. Investigator confirmed clinical diagnosis of ulcerative PG. Diagnosis shall be
supported by clinical assessment of PG symptoms via PARACELSUS score (Jockenhofer,
Wollina et al. 2019) of 10 points or more (see Appendix - Section 12.1). Note: in case
of PARACELSUS score < 10, additional justification shall be provided by the
investigator to support clinical diagnosis of ulcerative PG.

3. Minimum of 1 evaluable PG ulcer (other than peristomal) which qualifies as the target
ulcer by meeting the following criteria (Orfaly, Reese et al. 2022): area of = 5 cm 2
at screening and baseline

- circulated by intact skin

- evaluable by at least 2-dimensional measurement

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with target ulcers exceeding 80 cm 2 .

2. Patients with target ulcer in transplanted skin.

3. Surgical wound debridement or negative pressure wound therapy (NPWT) for the target
ulcer within 4 weeks before baseline (i.e., start of treatment with IMP).

4. Patient with previous exposure to vilobelimab (IFX-1) prior to baseline (i.e., start
of treatment with IMP).

5. Patient receives/has received a vaccine within 2 weeks prior to baseline (i.e., start
of treatment with IMP).

6. Any active infection requiring systemic antibiotic or other systemic treatment or
suppressive anti-infective therapy within 2 weeks prior to baseline (i.e., start of
treatment with IMP).

7. Patients received any systemic medical treatment for PG within 4 weeks prior to
baseline

8. Patients received any biological or immunomodulatory therapy for PG within 4 weeks
prior to baseline (i.e., start of treatment with IMP), except existing biologic or
immunomodulatory therapy used for an underlying disease (other than PG at a stable
therapy with no dose adjustments for at least two maintenance doses prior to screening
this is allowed to be continued.

9. Patients receiving corticosteroids treatment for PG of more than 10 mg/day of
prednisone or equivalent within 4 weeks prior to baseline (i.e., start of treatment
with IMP).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2026
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NewSouth WalesVIC
Recruitment hospital [1] 0 0
Premier Specialists - Kogarah
Recruitment hospital [2] 0 0
The Alfred Hospital, Melbourne - Melbourne
Recruitment hospital [3] 0 0
Veracity Clinical Research Pty Ltd (ACN 163 889 361) as trustee for the MLS Trust (ABN 49 688 437 341) - Brisbane
Recruitment postcode(s) [1] 0 0
- Kogarah
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
France
State/province [9] 0 0
Occitanie
Country [10] 0 0
France
State/province [10] 0 0
Lyon
Country [11] 0 0
France
State/province [11] 0 0
Nantes
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
Germany
State/province [13] 0 0
Baden Würrtemberg
Country [14] 0 0
Germany
State/province [14] 0 0
Bavaria
Country [15] 0 0
Germany
State/province [15] 0 0
Hessen
Country [16] 0 0
Germany
State/province [16] 0 0
Nordrhein-Westfalen
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalia
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Leipzig
Country [21] 0 0
Hungary
State/province [21] 0 0
Csongrad-Csanad
Country [22] 0 0
Hungary
State/province [22] 0 0
Hadju-Bihar
Country [23] 0 0
Hungary
State/province [23] 0 0
Pécs
Country [24] 0 0
Hungary
State/province [24] 0 0
Szeged
Country [25] 0 0
Italy
State/province [25] 0 0
Milan
Country [26] 0 0
Italy
State/province [26] 0 0
Turin
Country [27] 0 0
Poland
State/province [27] 0 0
Lower Silesia
Country [28] 0 0
Poland
State/province [28] 0 0
Mazowsze
Country [29] 0 0
Poland
State/province [29] 0 0
Warminsko
Country [30] 0 0
Poland
State/province [30] 0 0
Warsaw
Country [31] 0 0
Poland
State/province [31] 0 0
Wroclaw
Country [32] 0 0
Poland
State/province [32] 0 0
Lódz
Country [33] 0 0
Spain
State/province [33] 0 0
Salamanca
Country [34] 0 0
Switzerland
State/province [34] 0 0
Basel

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
InflaRx GmbH
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to
investigate efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma
gangrenosum
Trial website
https://clinicaltrials.gov/ct2/show/NCT05964413
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dorothee Neukirchen, Dr.
Address 0 0
Country 0 0
Phone 0 0
+49 89 4141897800
Fax 0 0
Email 0 0
clinicaltrials@inflarx.de
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05964413