Combination of Sotyktu and Enstilar for Plaque Psoriasis

NCT ID: NCT06329258

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-06
• Study Completion Date: 2023-11-13

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Deucravacitinib in combination with Enstilar

deucravacitinib in combination with Enstilar

Group Type: EXPERIMENTAL

Enstilar

Intervention Type: DRUG

Add on Enstilar

Deucravacitinib

Intervention Type: DRUG

6mg QD

Deucravacitinib monotherapy

monotherapy

Group Type: EXPERIMENTAL

Deucravacitinib

Intervention Type: DRUG

6mg QD

Interventions

Enstilar

Add on Enstilar

Intervention Type: DRUG

Deucravacitinib

6mg QD

Intervention Type: DRUG

Other Intervention Names

calcipotriene and betamethasone; Sotyktu

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Psoriasis Treatment Center of Central New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Schweiger Derm Group

East Windsor, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PTC09

Identifier Type: -

Identifier Source: org_study_id