Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis

Last updated: March 12, 2019
Sponsor: L.H. Kircik, M.D.
Overall Status: Completed

Phase

4

Condition

Skin Wounds

Rash

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03441789
ENS-1701
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study seeks to show whether there is a benefit of prescribing Enstilar with Otezla in the treatment of patients with moderate plaque type psoriasis. Subjects will be randomized to study treatment at a 1:1 ratio of Otezla plus Enstilar foam versus Otezla plus vehicle foam.

Eligibility Criteria

Inclusion

Inclusion Criteria: I. Outpatient, male or female subjects of any race, 18 years of age or higher. Femalesubjects of childbearing potential must have a (-)UPT (urine pregnancy test) result atwithin 7 days of the first dose of study drug and practice a reliable method ofcontraception throughout the study; A female is considered of childbearing potential unless she is:

  • postmenopausal ≥ 5 years of age, without a uterus and/or both ovaries; or has beensurgically sterile for ≥ 6 moths. Reliable methods of contraception are:

  • hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drugadministration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomizedpartner.

[Exception: Female subjects of CBP (child bearing potential) who are not sexually activeare not required to practice a reliable method of contraception and may be enrolled at theInvestigator's discretion provided they are counseled to remain sexually inactive for theduration of the study and understand the risks involved in getting pregnant during thestudy.] ii. Subjects with moderate plaque type psoriasis who have been started oncommercial Otezla within the last 10 days. iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand studyrequirements and sign Informed Consent/HIPAA forms.

Exclusion

Exclusion Criteria: I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potentialand not practicing a reliable method of birth control, or male subjects planning apregnancy with their spouse or partner while in the study. ii. History of hypercalcemia or vitamin D toxicity or history of significant renal orhepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv.Serious skin condition (other than psoriasis) or uncontrolled medical condition (in theopinion of the investigator). v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations ofpsoriasis. vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug oralcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessmentsrequired by the protocol. ix. Current enrollment in another clinical study and treatmentwith another experimental drug or approved therapy for experimental use within 30 daysprior to the Screening Visit.

Study Design

Total Participants: 28
Study Start date:
September 18, 2017
Estimated Completion Date:
October 22, 2018

Study Description

Approximately 50 subjects from 4 sites will be enrolled in this investigator-blind study. Subjects will be randomized 1:1 to Otezla plus Enstilar foam or Otezla plus vehicle foam and all adverse events and concomitant medications will be recorded.

Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis who have been started on commercial Otezla in the last 7 days will be randomized to study treatment as outlined above.

Enstilar or the vehicle will be initiated for the first 4 weeks and then Otezla will be continued as monotherapy for the next 8 weeks. Enstilar or the vehicle will be reinitiated for the last 4 weeks of the study. Total study period is 16 weeks and study visits will occur as follows: screening/baseline, week 1, 2, 3, 4, week 12, and week 16. Study assessments at each visit will be PASI, BSA, PGA, Itch VAS, DLQI, and standard medical assessments. There will be standard medication/treatment and washout periods.

Connect with a study center

  • Center for Dermatology and Laser Surgery

    Sacramento, California 95819
    United States

    Site Not Available

  • Skin Sciences, PLLC

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Lawrence J. Green, MD LLC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Dermatology & Laser Center of Charleston

    Charleston, South Carolina 29414
    United States

    Site Not Available

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