Efficacy of Bimekizumab in Adults With Pyoderma Gangrenosum

ConditionPyoderma Gangrenosum

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorOregon Health and Science University

About this trial

The purpose of the study is to learn more about an experimental drug bimekizumab that may be helpful for Pyoderma Gangrenosum (PG). Bimekizumab will be referred to as the study drug throughout this form. The investigators are hoping to find out if bimekizumab helps in healing PG wounds. The study drug is experimental. It has been approved by the FDA for use in adults with psoriatic conditions but not for Pyoderma Gangrenosum (PG).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place)

Have a diagnosis of at least one PG ulcer defined by the investigator on the basis of results from clinical and/or histological and/or laboratory assessments: Classic PG defined as deep ulceration with undermining violaceous borders and PARACELSUS score >10. If multiple ulcers are present, the largest ulcer (defined by greatest surface area) will be designated the target ulcer and followed throughout the study.

Subject has a minimum of 1 evaluable ulcer (4cm2 - 225cm2) at screening.

Be a candidate for systemic therapy.

Disqualifiers

4 weeks for any therapeutic agent directly targeted to IL-17 including, but not limited to, secukinumab, brodalumab, ixekizumab

8 weeks for infliximab;

6 weeks for adalimumab;

4 weeks for cyclosporine A, etanercept, inhibitors of the JAK/TYK pathway and PD4 inhibitors;

Trial design

Design model

Single group

Treatments tested in this trial

Bimekizumab
Drug
Participants will receive bimekizumab 320 mg administered subcutaneously every 2 weeks for the first 16 weeks, followed by 320 mg every 4 weeks through Week 24

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: BimekizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Proportion of participants that achieve a PGA score of ≤ 1 at week-24.

Time frame

24 weeks

Secondary outcomes

Proportion of Participants Achieving Complete Re-epithelialization of the Target Ulcer

Complete re-epithelialization of the target ulcer, defined as full wound closure without drainage or dressing requirements, among participants who are candidates for systemic therapy.

Time frame

Baseline through Week 24

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Number of participants with treatment-emergent adverse events, including serious adverse events, related and unrelated to bimekizumab.

Time frame

Baseline through Week 36 (final safety follow-up)

Impact of skin disease on quality of life

A 3-item questionnaire assessing three domains of quality of life impact; symptoms, emotions, and function related to skin disease.

Time frame

By week 28

Quality of life via Participant Global Assessment

Measures an individual's overall impression of their health, disease severity, or treatment response.

Time frame

By week 28

Other outcomes

Change From Baseline in Cytokine Gene Expression

Change from baseline in cytokine gene expression measured in skin and blood samples.

Time frame

Baseline, Week 12, Week 24

Presence and Quantity of Hyperechoic Oval Structures, Hair Tracts, and U-shaped Vessels on High-Frequency Ultrasound

Presence and amount of hyperechoic oval structures, hair tracts, and U-shaped vessels identified at the target ulcer by high-frequency ultrasound imaging.

Time frame

Baseline, Week 12, Week 24

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

UCB Pharma

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: