NCT06329258

Combination of Sotyktu and Enstilar for Plaque Psoriasis

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Psoriasis Treatment Center of Central New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	Enstilar	Add on Enstilar
DRUG	Deucravacitinib	6mg QD

Timeline

• Start date: 2022-12-06
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2024-03-25
• Last updated: 2024-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study