Clinical trial NCT03441789: Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Official title: Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

I. Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT (urine pregnancy test) result at within 7 days of the first dose of study drug and practice a reliable method of contraception 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 been surgically sterile for ≥ 6 moths.

Reliable methods of contraception are:

- hormonal methods or IUD (intrauterine device) in use ≥ 90 days prior to study drug administration, barrier methods plus spermicide in use ≥ 14 days prior, or vasectomized partner.

\[Exception: Female subjects of CBP (child bearing potential) who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.\] ii. Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days.

iii. Physician Global Assessment (PGA) score of 3. iv. Able to understand study requirements and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

I. Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study.

ii. History of hypercalcemia or vitamin D toxicity or history of significant renal or hepatic disease iii. Patients with guttate, erythrodermic, or pustular psoriasis iv. Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator).

v. Skin conditions (e.g.eczema) other than psoriasis that may interfere with evaluations of psoriasis.

vi. Known hypersensitivity to Enstilar Foam or any of its components. vii. Current drug or alcohol abuse (Investigator opinion). viii. Subject unable to commit to all the assessments required by the protocol. ix. Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.

Primary outcomes:
measure: Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
timeFrame: 16 weeks
Secondary outcomes:
measure: Percent of Subjects With PASI 75 at Week 4 and Week 12
timeFrame: 4 weeks, 12 weeks
measure: Percent of Subjects With PASI 90 and 100 at Week 16
timeFrame: 16 weeks
measure: Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16
timeFrame: 4 weeks, 12 weeks, 16 weeks
measure: Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
timeFrame: 4 weeks, 12 weeks, 16 weeks
measure: Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
timeFrame: 4 weeks, 12, weeks, 16 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J. Green, MD LLC
state: Maryland
city: Charleston
country: United States
facility: Dermatology & Laser Center of Charleston
state: South Carolina
Study officials:
References: