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Enstilar in Combination With Enbrel or Humira for Plaque Psoriasis
Phase 4
Recruiting
Research Sponsored by Psoriasis Treatment Center of Central New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
Summary
4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QOD to patients with 2-10% BSA who are receiving etanercept or adalimumab for at least 24 weeks
Eligible Conditions
- Psoriasis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PGA x BSA improvement
Secondary study objectives
BSA improvement
Dermatology Life Quality Index improvement
Itch Numerical Rating Scale
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Open Label EnstilarExperimental Treatment1 Intervention
once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Betamethasone
FDA approved
Find a Location
Who is running the clinical trial?
Psoriasis Treatment Center of Central New JerseyLead Sponsor
14 Previous Clinical Trials
412 Total Patients Enrolled
13 Trials studying Psoriasis
372 Patients Enrolled for Psoriasis
LEO PharmaIndustry Sponsor
271 Previous Clinical Trials
188,843 Total Patients Enrolled
86 Trials studying Psoriasis
33,202 Patients Enrolled for Psoriasis