Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorOregon Health and Science University
About this trial
A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Willingness to comply with study procedures/requirements
Capable of giving informed consent
Diagnosis of at least one PG ulcer by clinical, histological and laboratory assessments with a minimum wound size of 4 cm2.
Undergoing at least once a week standard of care wound care at home or at a wound care facility
Disqualifiers
Has previously received at any time any therapeutic agent directly targeted to IL-23 including, but not limited to, guselkumab, risankizumab, tildrakuzumab, or mirikizumab
12 weeks for ustekinumab, ixekizumab, secukinumab, brodalumab;
8 weeks for infliximab;
6 weeks for adalimumab;
Trial design
Design model
Single group
Treatments tested in this trial
Guselkumab
DrugSubjects with PG will be treated with 100 mg in a pre-filled syringe to be injected subcutaneously every 4 weeks for 28 weeks.
Treatment groups
17 Participants
are divided into 1 treatment groupGroup A: Guselkumab for PGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Healing
Defined as the proportion of patients with complete re-epithelization, defined as a100% re-epithelialization without any drainage of the target ulcer at week 32.
Time frame
Week 32Secondary outcomes
1
Physician Global Assessment (PGA)
Assessing the proportion of patients that show target ulcer healing in response to study treatment as measured by achieving PGA between 0 and 1 after treatment with guselkumab at week 32. This scale has been used in previous trials: 0 = total resolution of target ulcer with no signs of active PG 1= almost completely healed target ulcer with only minimal signs of active PG 2 = evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin 3 = evidence of target ulcer healing which involves less than 50% of ulcer/margin 4 = no evidence of target healing ulcer
Time frame
Week 322
Decrease in ulcer area size long-term
The proportion of patients with decrease in ulcer area size of at least 50% after treatment at week 32
Time frame
Week 323
Decrease in ulcer area size short-term
The proportion of patients with decrease in ulcer area size of at least 50% after treatment at Week 16
Time frame
Week 164
Mean decrease in ulcer area size short-term
Mean decrease in ulcer area size from Week 0 to Week 16
Time frame
Week 16Other outcomes
1
Evaluation of cytokine gene expression
Cytokine gene expression before and after treatment in skin, wound fluid, saliva and blood samples measured by enzyme-linked immunosorbent assay (ELISA)
Time frame
Week 0 and Week 32Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
Janssen Scientific Affairs, LLC
Collaborator
Ohio State University
Collaborator
Source ClinicalTrials.gov