Combination of Sotyktu and Enstilar for Plaque Psoriasis

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: Enstilar; Drug: Deucravacitinib

• Registration Number: NCT06329258
• Lead Sponsor: Psoriasis Treatment Center of Central New Jersey

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.

Study Timeline

• Study Start: 2022-12-06
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Status Verified: 2024-03
• Study First Submitted: 2024-03-14
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deucravacitinib in combination with Enstilar	Deucravacitinib	deucravacitinib in combination with Enstilar
Deucravacitinib monotherapy	Deucravacitinib	monotherapy
Deucravacitinib in combination with Enstilar	Enstilar	deucravacitinib in combination with Enstilar

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index 75 at week 12	12 weeks	Proportion of subjects achieving PASI 75 at week 12 for patients in the Deucravacitinib + Enstilar combination arm.

Trial Locations

Locations (1)

Schweiger Derm Group; 🇺🇸 East Windsor, New Jersey, United States