- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03441789
Efficacy and Safety of Enstilar Foam in Combination With Apremilast (Otezla) in Patients With Moderate Plaque Psoriasis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95819
- Center for Dermatology and Laser Surgery
-
-
Kentucky
-
Louisville, Kentucky, United States, 40217
- Skin Sciences, PLLC
-
-
Maryland
-
Rockville, Maryland, United States, 20850
- Lawrence J. Green, MD LLC
-
-
South Carolina
-
Charleston, South Carolina, United States, 29414
- Dermatology & Laser Center of Charleston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Otezla plus Enstilar foam
Subjects randomized to this group will receive Otezla 30mg by mouth twice daily and Enstilar applied to affected areas once daily
|
Enstilar foam applied to affected areas daily
Other Names:
Otezla 30mg
|
Placebo Comparator: Otezla plus vehicle foam
Subjects in this group will take Otezla 30mg by mouth twice daily and vehicle foam applied to affected areas once daily
|
Otezla 30mg
vehicle foam applied to affected areas once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Subjects With a Psoriasis Assessment and Severity Index (PASI) 75 at Week 16
Time Frame: 16 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Subjects With PASI 75 at Week 4 and Week 12
Time Frame: 4 weeks, 12 weeks
|
Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis.
It 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.)
|
4 weeks, 12 weeks
|
Percent of Subjects With PASI 90 and 100 at Week 16
Time Frame: 16 weeks
|
Psoriasis Area & Severity Index (PASI) is a tool used to measure the severity of psoriasis.
It 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.)
|
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
Time Frame: 4 weeks, 12 weeks, 16 weeks
|
The Investigator will rate the severity of of disease based on the assessment of 3 clinical signs (erythema, induration, desquamation) wherein 0=no signs of psoriasis, 1=almost clear, 2=mild, 3=moderate, 4=severe
|
4 weeks, 12 weeks, 16 weeks
|
Global Improvement in Itch Visual Analogue Scale (VAS) at Week 4,12 and 16
Time Frame: 4 weeks, 12 weeks, 16 weeks
|
The Itch VAS (Visual Analog Scale) is completed by subjects wherein they are asked to rate the severity of their itching over the last 48 hours on a scale from 0 (no itching) to 10 (unbearable itching); low scores indicate a better outcome.
|
4 weeks, 12 weeks, 16 weeks
|
Global Percent Improvement in Dermatologic Quality of Life Index (DLQI) at Week 4, 12, and 16
Time Frame: 4 weeks, 12, weeks, 16 weeks
|
The DLQI is a 10-question tool completed by subjects to ascertain the severity of disease based on the extent to which disease interferes with daily life.
Each question is scored according to the response wherein Very Much =3, A lot=2, A little=1 and Not at all=0.
The sum of all responses is then recorded on a scale from 0 to 30, lower scores indicating better quality of life.
|
4 weeks, 12, weeks, 16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Skin Diseases, Papulosquamous
- Psoriasis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Betamethasone
- Betamethasone Valerate
- Betamethasone-17,21-dipropionate
- Betamethasone benzoate
- Calcipotriene
- Betamethasone sodium phosphate
Other Study ID Numbers
- ENS-1701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Plaque Psoriasis
-
UCB Biopharma SRLRecruitingModerate Chronic Plaque Psoriasis | Severe Chronic Plaque Psoriasis | Mixed Guttate/Plaque PsoriasisUnited States, Canada, Puerto Rico
-
Idera Pharmaceuticals, Inc.CompletedModerate to Severe Plaque Psoriasis | Actively Extending Plaque PsoriasisUnited States
-
Fresenius Kabi SwissBioSim GmbHMerck KGaA, Darmstadt, GermanyCompletedPsoriasis | Moderate to Severe Plaque Psoriasis | Plaque Type PsoriasisUnited States, Canada, Czechia, Hungary, Russian Federation, Bulgaria, Mexico, United Kingdom, Poland, Germany, Estonia, France
-
UCB Biopharma SRLCompletedModerate to Severe Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Canada, Germany, Hungary, Korea, Republic of, Poland, Russian Federation, Taiwan
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, Germany, Hungary, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, United Kingdom
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Australia, Belgium, Canada, France, Germany, Netherlands, Poland, Spain, Turkey, United Kingdom
-
Biocon Biologics Inc.MEDA Pharma GmbH & Co. KG; Mylan Inc.; IQVIA Pvt. LtdCompletedHulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and ImmunogenicityModerate Chronic Plaque Psoriasis | Severe Chronic Plaque PsoriasisBulgaria, Czechia, Estonia, Poland
-
UCB Biopharma SRLCompletedModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisUnited States, Canada
-
UCB Biopharma SRLActive, not recruitingModerate to Severe Chronic Plaque Psoriasis | Chronic Plaque PsoriasisChina
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
Clinical Trials on Enstilar
-
Icahn School of Medicine at Mount SinaiCompletedPsoriasis | Plaque PsoriasisUnited States
-
Aarhus University HospitalActive, not recruitingSkin Diseases | Psoriasis | Skin Diseases, Papulosquamous | Psoriasis Vulgaris | Skin and Connective Tissue DiseasesDenmark
-
Psoriasis Treatment Center of Central New JerseyEli Lilly and CompanyUnknown
-
Bispebjerg HospitalLEO Innovation LabCompleted
-
LEO PharmaCompletedPsoriasis VulgarisJapan
-
Forest LaboratoriesTerminatedHeart Diseases | Cardiovascular Diseases | Arrhythmias, Cardiac | Implantable Cardioverter DefibrillatorUnited States, Belgium, Canada, Czech Republic, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden
-
LEO PharmaCompleted
-
Derm Research, PLLCCompletedPlaque PsoriasisUnited States
-
Psoriasis Treatment Center of Central New JerseyCompleted