The Maintenance Effect of Enstilar Foam in Combination With Otezla

Sponsor

Derm Research, PLLC (Other)

Overall Status

Recruiting

CT.gov ID

NCT04555707

Collaborator

(none)

Enrollment

Location

Arm

15.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Drug: Apremilast 30mg Drug: calcipotriene and betamethasone dipropionate	Phase 4

Detailed Description

Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Maintenance Effect of Enstilar Foam in Combination With Otezla

Actual Study Start Date :

Jun 24, 2020

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Otezla + Enstilar	Drug: Apremilast 30mg 30mg PO BID started within 10 days of baseline Other Names: Otezla Drug: calcipotriene and betamethasone dipropionate 1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20. Other Names: Enstilar

Arm

Intervention/Treatment

Experimental: Otezla + Enstilar

Drug: Apremilast 30mg

30mg PO BID started within 10 days of baseline

Other Names:

Otezla

Drug: calcipotriene and betamethasone dipropionate

1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.

Other Names:

Enstilar

Outcome Measures

Primary Outcome Measures

Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4 [4 weeks]
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate

Secondary Outcome Measures

Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment [week 4, week 16, week 20]
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment [week 4, week 16, week 20]
Patient's Global Assessment of Disease Severity. 0=Clear, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe
Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4 [4 weeks]
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Percent of subjects who achieve PASI 75 at week 16 [16 weeks]
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
DLQI (dermatology life quality index) at week 4 [4 weeks]
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
DLQI at week 16 [16 weeks]
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale: Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Itch VAS (visual analogue scale) at week 4 and week 16 [4 week, 16 weeks]
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT 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 > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M.

Reliable methods of contraception are:

hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.

[Exception: Female subjects of CBP 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.]

Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days
Physician Global Assessment (PGA) score of 3
Able to understand study requirements and sign Informed Consent/HIPAA forms

Exclusion Criteria:

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
History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease
Patients with guttate, erythrodermic, or pustular psoriasis
Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis
Known hypersensitivity to Enstilar Foam or any of its components
Current drug or alcohol abuse (Investigator opinion.)
Subject unable to commit to all the assessments required by the protocol
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.