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Clinical trial

Open Label Exploratory Phase IIa Trial to Investigate the Safety and Efficacy of IFX-1 in Treating Patients With Pyoderma Gangrenosum (OPTIMA)

ID
Name
IFX-1-P2.7
Description
The purpose of this study is to determine whether vilobelimab (development name: IFX-1) is safe and effective in the treatment of pyoderma gangrenosum.
Trial arms
Trial start
2019-05-16
Estimated PCD
2022-01-03
Trial end
2022-01-03
Status
Completed
Phase
Early phase I
Treatment
vilobelimab
IV infusions of vilobelimab diluted in sodium chloride.
Arms:
vilobelimab 1600 mg Q2W, vilobelimab 2400 mg Q2W, vilobelimab 800 mg Q2W
Other names:
IFX-1, CaCP29
Size
19
Primary endpoint
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
Eligibility criteria
Inclusion Criteria: * 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 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'IV infusions of vilobelimab diluted in sodium chloride', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 19, 'type': 'ACTUAL'}}
Updated at
2023-09-14

1 organization

1 product

1 indication

Organization
InflaRx
Product
vilobelimab
Indication
Pyoderma Gangrenosum