Combination of Sotyktu and Enstilar for Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06329258
• Other study ID #: PTC09
• Status: Completed
• Phase: Phase 4
• Start date: December 6, 2022
• Est. completion date: November 13, 2023

Study information

• Verified date: March 2024
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

combination deucravacitinib and enstilar foam

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adult = 18 years of age;

2. Diagnosis of chronic plaque-type psoriasis

3. Moderate to severe plaque type psoriasis as defined at baseline by:

• BSA affected by plaque-type psoriasis of 10% or greater
• PGA score of 3 or greater
• PASI = 12.

4. Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis.

Exclusion Criteria:

1. Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.

2. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis

3. Use of oral systemic medications or PUVA phototherapy for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).

4. Prior use of biologics within the following periods:

• Etanercept - 4 weeks
• Adalimumab or certolizumab pegol - 8 weeks
• IL-17 antagonists - 16 weeks
• Ustekinumab or IL-23 pathway inhibitors - 24 weeks
• Other biologics - 5 half-lives

5. Patient used topical therapies or UVB phototherapy to treat psoriasis within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• Enstilar
Add on Enstilar
• Deucravacitinib
6mg QD

Locations

Country	Name	City	State
United States	Schweiger Derm Group	East Windsor	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area and Severity Index 75 at week 12	Proportion of subjects achieving PASI 75 at week 12 for patients in the Deucravacitinib + Enstilar combination arm.	12 weeks