Combination of Sotyktu and Enstilar for Plaque Psoriasis

NCT06329258 | Completed Phase 4 FDA Drug

• 1 other identifier: PTC09
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

combination deucravacitinib and enstilar foam

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Deucravacitinib in combination with Enstilar

EXPERIMENTAL

deucravacitinib in combination with Enstilar

Drug: Enstilar; Drug: Deucravacitinib

Deucravacitinib monotherapy

EXPERIMENTAL

monotherapy

Drug: Deucravacitinib

Interventions

Enstilar DRUG

Add on Enstilar

Also known as: calcipotriene and betamethasone

Deucravacitinib in combination with Enstilar

Deucravacitinib DRUG

6mg QD

Also known as: Sotyktu

Deucravacitinib in combination with Enstilar; Deucravacitinib monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult ≥ 18 years of age;
• Diagnosis of chronic plaque-type psoriasis
• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Psoriasis Treatment Center of Central New Jersey: lead

Study Sites (1)

Schweiger Derm Group

East Windsor, New Jersey, 08520, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

betamethasone dipropionate, calcipotriol drug combination; calcipotriene; Betamethasone; deucravacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open label

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 25, 2024
• Study Start: December 6, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

US (1)