Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06532136
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Deucravacitinib Rosacea
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Treatment of Moderate-to-severe Papulopustular Rosacea with Deucravacitinib
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a double-blind randomized placebo-controlled study in which participants will be randomized 21 to receive 6 mg deucravacitinib or placebo once daily for 8 weeks followed by an open label extension during which all participants will receive 6 mg deucravacitinib once daily for an additional 8 weeks The open-label extension has been incorporated in order to ensure all participants receive benefit from the study as well as to benefit from the intra-patient comparison of placebo to drug and to provide longer-term clinical data
The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea PPR participants will have baseline Investigator Global Assessment IGA score of at least 3 and at least 12 inflammatory lesions
Beginning at BaselineWeek 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks At week 8 those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16 Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16 All participants will return for visits at Weeks 4 8 12 and 16 following study treatment initiation for repeat clinical assessments medication reviews tape-strip collection blood and urine sample collections and monitoring for adverse events
The study will include 33 adult participants with moderate-to-severe Papulopustular Rosacea PPR participants will have baseline Investigator Global Assessment IGA score of at least 3 and at least 12 inflammatory lesions
Beginning at BaselineWeek 0 enrolled participants will receive 6mg deucravacitinib or placebo once daily for 8 weeks At week 8 those participants originally randomized to placebo will initiate dosing with 6mg deucravacitinib once daily for 8 weeks until Week 16 Participants previously randomized to deucravacitinib will continue to receive deucravacitinib for an additional 8 weeks until Week 16 All participants will return for visits at Weeks 4 8 12 and 16 following study treatment initiation for repeat clinical assessments medication reviews tape-strip collection blood and urine sample collections and monitoring for adverse events
Detailed Description:
After providing consent all subjects will be assessed for study eligibility which includes a review of the subjects past and current medical conditions familial medical history and detailed review of past and current medications Subjects will also undergo a review of past topical treatmentstherapies for PPR and clinical assessments inflammatory lesion count IGA CEA PSA Subjects will have urine for urinalysis and blood for Complete Blood Count with differential Comprehensive Metabolic Panel lipid panel creatinine kinase C-Reactive Protein HIV HCV and HBV collected for safety analysis In addition subjects will be screened for tuberculosis via PPD or quantiferon gold testing and pregnancy if applicable via serum pregnancy test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None