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

NCT03137160 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2017H0045
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pyoderma Gangrenosum

Outcome Measures

Primary Outcomes (1)

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

  The primary outcome will be the proportion of subjects achieving a 2-point reduction in the 5-point investigator global assessment for the target ulcer at Week 12. The measure type and unit of measure are the proportion of participants. The IGA utilizes a 5 point Investigator Global Assessment measuring disease severity from 0- clear, 1-minimal, 2-mild, 3-moderate, 4- severe. 4 is the worst

  12 Weeks

Study Arms (1)

Ixekizumab (Taltz)

EXPERIMENTAL

We have received funding for only a small pilot study to prove a benefit from Interleukin-17 inhibition in Pyoderma Gangrenosum . Therefore, there is only one treatment arm. The primary outcome will be a comparison of week 12 to baseline regarding a two-point improvement in the Investigator Global Assessment.

Biological: Ixekizumab

Interventions

Ixekizumab BIOLOGICAL

Injection

Also known as: Taltz

Ixekizumab (Taltz)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have a clinical diagnosis of classic Pyoderma Gangrenosum for at least 3 months as determined by the investigator and an external reviewer on the basis of results from clinical, histological and laboratory assessments
• At screening, have a Pyoderma Gangrenosum ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c.
• a. Stable or increasing size within 2 months preceding screening by patient report or documentation b. Features such as violaceous border, undermining, d. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulators are permitted.
• e. Wound debridement within 2 weeks of Day 0; dressing changes allowed per investigator discretion.
• g. Systemic antibiotics within 2 weeks of Day 0 h. Live, attenuated vaccines within 3 months of Day 0; or live, seasonal-flu- or H1N1 vaccines within 2 weeks of Day 0. Note: recombinant- and/or killed vaccines are permitted.

You may not qualify if:

• 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
• Systemic corticosteroids \> 20 mg per day (prednisone or prednisone equivalent) within 8 weeks of Day 0, or change in dose within 8 weeks of Day 0. Steroids may be tapered (although not increased above the Day 0 dose) during the trial as determined by the investigator.
• they are prescribed at stable doses for two months prior to baseline and are 20 mg or less per day of prednisone or other equivalently-dosed corticosteroids.
• \. Intralesional corticosteroids within 4 weeks of screening and during the study are not permitted 5. Other therapies that are non-immunosuppressive and non-investigational can be started or continued at physician discretion provided the medicine has no history of association with progressive multifocal leukoencephalopathy. Antibiotics may be used as needed for evidence of superinfection, positive culture results, malodor, green discharge, etc.

Sponsors & Collaborators

• Ohio State University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

The Ohio State University Dermatology

Gahanna, Ohio, 43230, United States

Location

MeSH Terms

Conditions

Pyoderma Gangrenosum

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer

Limitations and Caveats

Trial stopped early due to safety. Patients were all previously hospitalized as well. High risk of re-hospitalization was not necessarily unexpected.

Results Point of Contact

• Title: Dr. Benjamin Kaffenberger, MD
• Organization: The Ohio State University- Dermatology

Benjamin.Kaffenberger@osumc.edu

6143463399

Study Officials

• Benjamin Kaffenberger, MD

  Dermatologist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: May 4, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: February 23, 2024
• Results First Posted: June 6, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)