Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
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|ClinicalTrials.gov Identifier: NCT04901325|
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : September 2, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pyoderma Gangrenosum Skin Diseases Wound Heal Pyoderma Skin Ulcer||Drug: Baricitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)|
|Actual Study Start Date :||September 29, 2021|
|Estimated Primary Completion Date :||July 5, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Baricitinib for PG
Subjects with PG will be treated with 4 mg once daily of baricitinib for 24 weeks in addition to starting stable dose (at least 2 weeks) of prednisone at 30 mg daily. Prednisone will be tapered based on a pre-established algorithm assessed by investigator.
Subjects with PG will be treated with 4 mg once daily of baricitinib for 24 weeks.
Other Name: Olumiant
- Healing [ Time Frame: Week 24 ]defined as the proportion of patients with complete re-epithelization of the target ulcer at week 24.
- Physician Global Assessment (PGA) [ Time Frame: Week 36 ]
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 baricitinib at week-36 52. 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
- Percent change in lesion surface area [ Time Frame: Week 0 and 24 ]The percent change in surface area of target lesion of PG (two-dimensional surface in cm²) using digital photography and acetate tracing at Week 0 and Week 24
- Mean change in lesion surface area [ Time Frame: Week 0 and 24 ]The mean change in surface area of target lesion of PG (two-dimensional surface in cm²) using digital photography and acetate tracing
- Mean change in Physician Global Assessment (PGA) [ Time Frame: Week 0 and 24 ]The mean change in Physician global assessment (PGA) 5-point scale at week 0 to week 24
- Participants receiving ≤8mg prednisone per day [ Time Frame: Over 24-week period of study. ]The proportion of participants who receive prednisone at a dose of 8 mg or less per day (physiological dose) over the 24-week period.
- Sustained healing [ Time Frame: Week 36 ]The proportion of patients with target ulcer that remains healed by week 36
- Decrease in ulcer area size [ Time Frame: Week 24 ]The proportion of patients with decrease in ulcer area size of at least 50% after treatment at week 24
- Time to healing [ Time Frame: Over 36-week period of study. ]Time to which sterile dressings are not required.
- Time to recurrence (weeks) [ Time Frame: 36 weeks ]Interval between target lesion healing and further episodes of PG at any site through the study.
- Number of treatment failures [ Time Frame: By week 24 ]Treatment intolerance, number of patients switching into standard of care or target lesion unhealed.
- Adverse reactions to medications [ Time Frame: Over 24-week period of study. ]Possibly-, probably- or related throughout the study.
- Quality of life change (as measured by the Dermatology Life Quality Index) [ Time Frame: Week 24 ]Proportion of subjects achieving a 4-point change in quality of life measured by the Dermatology Life Quality Index (DLQI) at week 24, and mean change in DLQI score at week 24. The DLQI is a validated tool for inflammatory skin conditions. It is a 10-question survey, scored 0 - 30 points. For inflammatory skin conditions, a 4-point change in DLQI score is considered clinically important.
- Mean change in quality of life (measured by Dermatology Life Quality Index) [ Time Frame: Week 0 and 24 ]Mean change in DLQI score from week 0 to week-24.
- Skin pain scale [ Time Frame: Week 0 to 24 ]Mean percentage in improvement in pain related to PG target ulcer measured by 0 - 10-point numeric pain rating scale (NRS) at week 0 and week-24. The pain NRS is a subject-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable."
- Evaluation of cytokine gene expression [ Time Frame: Week 0 and week 24 ]15. Evaluation of cytokine gene expression before and after treatment in skin and blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04901325
|Contact: Alex G Ortega- Loayza, MD, MCRemail@example.com|
|Contact: Morgan Vague, BAfirstname.lastname@example.org|
|Principal Investigator:||Alex G Ortega-Loayza, MD, MCR||Oregon Health & Science University, Department of Dermatology|