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OpenTrials
Completed

NCT Number: NCT06329258

Combination of Sotyktu and Enstilar for Plaque Psoriasis

combination deucravacitinib and enstilar foam

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Schweiger Derm Group

East Windsor, New Jersey, 08520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Enstilar

Drug

Add on Enstilar

Other names: calcipotriene and betamethasone

Deucravacitinib

Drug

6mg QD

Other names: Sotyktu

Primary outcomes

  1. Psoriasis Area and Severity Index 75 at week 12

    Time frame: 12 weeks

    Proportion of subjects achieving PASI 75 at week 12 for patients in the Deucravacitinib + Enstilar combination arm.

Sponsors and collaborators

Lead sponsor

Psoriasis Treatment Center of Central New Jersey

Other

Registry information

Official study title

A Single Center Study to Evaluate the Effectiveness and Safety of SOTYKTU® (Deucravacitinib) in Combination With Enstilar® for Moderate to Severe Plaque Psoriasis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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