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

combination deucravacitinib and enstilar foam

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Enstilar; Drug: Deucravacitinib

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Schweiger Derm Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deucravacitinib in combination with Enstilar; deucravacitinib in combination with Enstilar	Drug: Enstilar; Add on Enstilar; Other Names: calcipotriene and betamethasone; Drug: Deucravacitinib; 6mg QD; Other Names: Sotyktu
Experimental: Deucravacitinib monotherapy; monotherapy	Drug: Deucravacitinib; 6mg QD; Other Names: Sotyktu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Psoriasis Treatment Center of Central New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Protein Kinase Inhibitors; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Calcipotriene; Deucravacitinib
• Other Study ID Numbers: PTC09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No