Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT06329258
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2024-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of Sotyktu and Enstilar for Plaque Psoriasis
Sponsor:
Psoriasis Treatment Center of Central New Jersey
Organization:
Study Overview
Official Title:
A Single Center Study to Evaluate the Effectiveness and Safety of SOTYKTU® (Deucravacitinib) in Combination With Enstilar® for Moderate to Severe Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
combination deucravacitinib and enstilar foam
Detailed Description:
30 adult patients with moderate to severe plaque psoriasis will be given Deucravacitinib 6mg QD for the first 8 weeks of the study.
At week 8:
Subjects who do not meet PASI 25 at week 8 will be discontinued from the study as non-responders.
Subjects who achieve ≥PASI 75 at week 8 will remain enrolled and continue Deucravacitinib 6mg QD monotherapy through week 24.
Subjects who achieved between PASI 25-74 response will receive 4 weeks of Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% applied QD in addition to continuing Deucravacitinib 6mg QD.
At week 12, (after 4 consecutive weeks of Enstilar), subjects in the PASI 25-74 group, will discontinue Enstilar QD and continue Deucravacitinib as monotherapy through week 24.
Subjects will return at week 28 for safety follow evaluation.
At week 8:
Subjects who do not meet PASI 25 at week 8 will be discontinued from the study as non-responders.
Subjects who achieve ≥PASI 75 at week 8 will remain enrolled and continue Deucravacitinib 6mg QD monotherapy through week 24.
Subjects who achieved between PASI 25-74 response will receive 4 weeks of Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% applied QD in addition to continuing Deucravacitinib 6mg QD.
At week 12, (after 4 consecutive weeks of Enstilar), subjects in the PASI 25-74 group, will discontinue Enstilar QD and continue Deucravacitinib as monotherapy through week 24.
Subjects will return at week 28 for safety follow evaluation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: