Pyoderma gangrenosum MedDRA version: 20.0 Level: PT Classification code 10037635 Term: Pyoderma gangrenosum System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: IFX-1
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 2250440-41-4
Current Sponsor code: IFX-1
Other descriptive name: Anti-(complement C5a) IgG4 chimeric monoclo
Sponsors
InflaRx GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Capable of giving signed informed consent as described in Regulatory and Ethical Considerations, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol, and approval for photographic documentation 2. Subjects must be 18 years or older, at the time of signing the informed consent 3. Male or female 4.Diagnosis of an ulcerative form of pyoderma gangrenosum confirmed by the investigator 5.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 Clinical examination (or photographic evidence) of •Peripheral erythema, undermining border, and tenderness at site of ulceration •Multiple ulcerations •Cribriform or “wrinkled paper” scar(s) at sites of healed ulcers 6.Subject has a minimum of 1 evaluable ulcer (=2 cm2) at screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: 1.Pyoderma gangrenosum target ulcer for more than 3 years before screening 2.Surgical wound debridement within the previous 2 weeks before screening 3.Any comorbidity such as psychiatric or general illness that may put the subject at risk as determined by investigator 4.Poor general condition that might affect wound healing, as determined by the investigator 5.One of the following abnormal laboratory findings at screening: •White blood cell count 1.5 times the upper limit of normal and/or alanine aminotransferase or aspartate aminotransferase >2.5 times upper limit of normal 6.Human immunodeficiency virus, hepatitis B or hepatitis C viral screening test showing evidence of active or chronic viral infection at screening or a documented history of the human immunodeficiency virus, hepatitis B, or hepatitis C 7.Evidence of active or latent tuberculosis 8.History of malignancy in the previous 5 years (except for non-melanoma skin cancer and cancer in-situ of the cervix) 9.Subjects with ulceration due to medical causes other than pyoderma gangrenosum (e.g. diabetic ulceration) 10.Infection requiring suppressive anti-infective therapy (such as latent tuberculosis, pneumocystis, aspergillosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) 11.Use of intravenous antibacterial, antiviral, anti-fungal, or anti-parasitic agents within 30 days before screening 12.Any drug treatment for pyoderma gangrenosum including corticosteroids (>10 mg prednisone or prednisone equivalent), 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 13.Received live attenuated vaccine within the previous 3 months before screening 14.Major surgery planned during the time of foreseen study participation 15.The subject has participated in an interventional clinical study during the 3 months before screening, or plans to participate in a clinical study 16.Previous exposure to IFX-1 in this or another study 17.Known hypersensitivity to polysorbate 80 (excipient of the IMP) 18.Prior exposure to anticomplement 5a before screening 19.History of sever anaphylactic reaction to any components of C5a before screening 20.Known or suspected active drug and/or alcohol abuse at screening 21.Breast feeding or pregnant woman at screening 22.Male and female subjects of childbearing potential unwilling to follow the contraceptive guidance in Appendix 4 during the treatment period and for at least 30 days after the last dose of IMP 23.Pregnancy or positive pregnancy test at screening 24.The subject is imprisoned or lawfully kept in an institution at screening 25.Evidence or suspicion that the subject might not comply with the requirements of the study protocol 26.The subject is an employee or direct relative of an employee at the study site or sponsor 27.Any other factor which, in the investigator’s opinion, is likely to compromise the subject’s ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore the safety of IFX-1 for the treatment of subjects with pyoderma gangrenosum;Secondary Objective: Explore the efficacy of IFX-1 for the treatment of pyoderma gangrenosum Explore additional clinical outcome parameters in subjects with pyoderma gangrenosum under the treatment with IFX-1;Primary end point(s): Occurrence, nature and intensity of treatment emergent adverse events (TEAEs), related TEAEs, serious TEAEs, and adverse events of special interest;Timepoint(s) of evaluation of this end point: Adverse Events are assessed at every visit; interim analysis and End of Trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Responder rate defined as Physician’s Global Assessment =3 of target ulcer at Visits V4, V6, V10, and V16 (End of Treatment [EOT]) Time to complete closure of pyoderma gangrenosum target ulcer (investigator assessment) Percentage change in wound area and wound volume (wound healing) of target ulcer between Visits V1-V4, V1-V6, V6-V10; V10-V16, and V1-V16 (photographic assessment) Rate of change per day in area of target ulcer (photographic assessment) Number of subjects with a decrease in area of target ulcer of 50% or more at Visit V16 (EOT) compared to baseline (photographic assessment) Number of subjects with a decrease in area of target ulcer of 100% at Visit V16 (EOT) compared to baseline (remission) (photographic assessment) Degree of erythema and border elevation of the target ulcer compared to baseline at Visits V4, V6, V10, and V16 (EOT) (investigator assessment) Mean change from baseline in pain assessed by Numeric Rating Scale (NRS) at Visits V4, V6, V10, and V16 (EOT) Mean change from baseline in Dermatology Life Quality Index (DLQI) at Visits V4, V6, V10, and V16 (EOT);Timepoint(s) of evaluation of this end point: Interim analysis and End of trial | — |
Countries
Poland, United States
Contacts
Public ContactClinical Research and Development
InflaRx GmbH
Outcome results
None listed