Taltz in Combination With Enstilar for Psoriasis
Primary Purpose
Psoriasis
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Enstilar
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Male or female adult ≥ 18 years of age;
- Diagnosis of chronic plaque-type
- Body Surface Area between 3%-8%.
- Patient has been treated with Taltz for a minimum of 24 weeks
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
- Able and willing to give written informed consent prior to performance of any study-related procedures.
Exclusion Criteria
-˂3% or >8% BSA
- Patient not receiving Taltz, or receiving Taltz <24 weeks
- Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breast feeding, or considering becoming pregnant during the study.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
- Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
- Patient received UVB phototherapy within 2 weeks of Baseline.
- Patient received PUVA phototherapy within 4 weeks of Baseline.
- Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Sites / Locations
- Psoriasis Treatment Center of Central New JerseyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enstilar
Arm Description
Enstilar foam
Outcomes
Primary Outcome Measures
Body Surface Area 0 or 1
Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.
Secondary Outcome Measures
Full Information
NCT ID
NCT04372277
First Posted
April 29, 2020
Last Updated
April 29, 2020
Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT04372277
Brief Title
Taltz in Combination With Enstilar for Psoriasis
Official Title
Open Label Study, Evaluating Taltz in Combination With Enstilar (Calcipotriene and Betamethasone Dipropionate) Foam in Psoriasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 28, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Enstilar in combination with Taltz for plaque psoriasis.
Detailed Description
A single center study of 25 subjects to assess the addition of Enstilar Foam in patients receiving Taltz for ≥ 24 weeks with BSA between 3% and 8%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Enstilar
Arm Type
Experimental
Arm Description
Enstilar foam
Intervention Type
Drug
Intervention Name(s)
Enstilar
Intervention Description
topical Enstilar foam
Primary Outcome Measure Information:
Title
Body Surface Area 0 or 1
Description
Body surface area where 1 palm is equivalent to 1%. Endpoint will evaluate number of patiens who achieve body surface are 0 or 1.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type
Body Surface Area between 3%-8%.
Patient has been treated with Taltz for a minimum of 24 weeks
Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination
Able and willing to give written informed consent prior to performance of any study-related procedures.
Exclusion Criteria
-˂3% or >8% BSA
Patient not receiving Taltz, or receiving Taltz <24 weeks
Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
Pregnant or breast feeding, or considering becoming pregnant during the study.
Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
Use of oral systemic medications for the treatment of psoriasis within 4 weeks.
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit.
Patient received UVB phototherapy within 2 weeks of Baseline.
Patient received PUVA phototherapy within 4 weeks of Baseline.
Patient has a known hypersensitivity to the excipients of Enstilar® as stated in the label.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Bagel, MD
Phone
6094434500
Email
dreamacres1@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elise Nelson
Phone
6094434500
Email
enelson@windsordermatology.com
Facility Information:
Facility Name
Psoriasis Treatment Center of Central New Jersey
City
East Windsor
State/Province
New Jersey
ZIP/Postal Code
08520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise Nelson
Phone
609-443-4500
Email
enelson@windsordermatology.com
First Name & Middle Initial & Last Name & Degree
Jerry Bagel, MD
First Name & Middle Initial & Last Name & Degree
David Nieves, MD
First Name & Middle Initial & Last Name & Degree
Wendy Myers, MD
First Name & Middle Initial & Last Name & Degree
Alexa Hetzel, PA-C
First Name & Middle Initial & Last Name & Degree
Brianna Butler, PA-C
12. IPD Sharing Statement
Learn more about this trial
Taltz in Combination With Enstilar for Psoriasis
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