CompletedPhase 2

An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

United States4 participantsStarted 2017-05-04

Plain-language summary

An Open-Label, Proof-Of-Concept, Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may jeopardize the subject's safety after exposure to the study drug, may confound the study results, or may interfere significantly with the subject's participation in the study
✕. History of malignancy within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-metastatic, squamous or basal cell carcinoma of the skin
✕. History of seropositivity for HIV antibody; active or carrier status of hepatitis B \[surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody\]; active hepatitis C (i.e. not treated or not cleared spontaneously, as confirmed by HCV PCR)
✕. History of severe allergic or anaphylactic reaction to monoclonal antibodies
✕. Systemic infection (excluding wound colonization) requiring oral antibiotics within 2 weeks of Day 0
✕. History of the following treatments:
✕. Anti-Tumor Necrosis Factor or other biologic therapies within 5 half-lives of screening
✕. Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) within 2 months of Day 0

The Proportion of Subjects Achieving 2-point Reduction in the 5-point Investigator Global Assessment (IGA) for the Target Ulcer at Week 12

Timeframe: 12 Weeks

NCT IDNCT03137160

SponsorOhio State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-08-16

Results submitted2021-05-04

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) or situation that may compromise the ability of the subject to give written informed consent, may put the subject at significant risk, may jeopardize the subject's safety after exposure to the study drug, may confound the study results, or may interfere significantly with the subject's participation in the study
✕. History of malignancy within 2 years of screening other than carcinoma in situ of the cervix or adequately treated, non-metastatic, squamous or basal cell carcinoma of the skin
✕. History of seropositivity for HIV antibody; active or carrier status of hepatitis B \[surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive with negative surface antibody\]; active hepatitis C (i.e. not treated or not cleared spontaneously, as confirmed by HCV PCR)
✕. History of severe allergic or anaphylactic reaction to monoclonal antibodies
✕. Systemic infection (excluding wound colonization) requiring oral antibiotics within 2 weeks of Day 0
✕. History of the following treatments:
✕. Anti-Tumor Necrosis Factor or other biologic therapies within 5 half-lives of screening
✕. Changes (addition, discontinuation, or changes in dose) in immunosuppressive medication (including cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, apremilast, dapsone, or corticosteroids) within 2 months of Day 0