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

NCT03441789 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ENS-1701
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16

  PASI combines the assessment of the severity of lesions and the area affected into a single score ranging from 0(no disease) to 72(maximal disease.) The body is divided into 4 sections: head (10% of total body surface area,) arms (20%,) trunk(30%,) and legs (40%.) Each of these is scored by itself and the 4 scores then combined to obtain thePASI. For each body area, the percent of skin area involved is estimated and graded based on this value (0=0% of area involved, 1=\<10%, 2=10-29%, 3=30-49%, 4=50-69%, 5=70-89%, 6=90-100%.) Within each area, the severity of disease is based on 3 clinical signs: erythema or redness, induration or thickness, and desquamation or scaliness. Each is graded on a scale from 0(none) to 4(maximum.) The sum of all 3 parameters is calculated for each body section, multiplied by the area score for that section and then multiplied by the weight of that section (.1for head, .2 arms, .3 trunk and .4 legs)

  16 weeks

Secondary Outcomes (5)

• Percent of Subjects With PASI 75 at Week 4 and Week 12

  4 weeks, 12 weeks

• Percent of Subjects With PASI 90 and 100 at Week 16

  16 weeks

• Per Cent of Patients With at Least 1-grade Improvement in Physicians Global Assessment (PGA) at Week 4 and Week 12 and Week 16

  4 weeks, 12 weeks, 16 weeks

• Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16

  4 weeks, 12 weeks, 16 weeks

• Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16

  4 weeks, 12, weeks, 16 weeks

Study Arms (2)

Otezla plus Enstilar foam

EXPERIMENTAL

Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily

Drug: Enstilar; Drug: Otezla

Otezla plus vehicle foam

PLACEBO COMPARATOR

Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily

Drug: Vehicle; Drug: Otezla

Interventions

Enstilar DRUG

Enstilar foam applied to affected areas daily

Also known as: calcipotriene and betamethasone dipropionate

Otezla plus Enstilar foam

Vehicle DRUG

vehicle foam applied to affected areas once daily

Otezla plus vehicle foam

Otezla DRUG

Otezla 30mg

Otezla plus Enstilar foam; Otezla plus vehicle foam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• L.H. Kircik, M.D.: lead

Study Sites (4)

Center for Dermatology and Laser Surgery

Sacramento, California, 95819, United States

Location

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

Lawrence J. Green, MD LLC

Rockville, Maryland, 20850, United States

Location

Dermatology & Laser Center of Charleston

Charleston, South Carolina, 29414, United States

Location

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination; apremilast

Results Point of Contact

• Title: M. McAllister
• Organization: Skin Sciences, PLLC

mmdermresearch@yahoo.com

5024519000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 22, 2018
• Study Start: September 18, 2017
• Primary Completion: October 1, 2018
• Study Completion: October 22, 2018
• Last Updated: March 14, 2019
• Results First Posted: March 13, 2019

Record last verified: 2019-03

Locations

US (4)