Clinical trial NCT06329258: Combination of Sotyktu and Enstilar for Plaque Psoriasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Psoriasis Treatment Center of Central New Jersey
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Psoriasis Area and Severity Index 75 at week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Windsor
country: United States
facility: Schweiger Derm Group
state: New Jersey
Study officials:
References: