Enstilar in Combination With Biologic Agents | NCT03080545

Studies
Enstilar in Combination With Biologic Agents

NCT03080545

Sponsor

Psoriasis Treatment Center of Central New Jersey

Status

Completed

Last Update Posted

Jan 3, 2018Actual

Enrollment

25Actual

Phase

Phase 4

Conditions

Psoriasis

Interventions

Enstilar 0.005%-0.064% Topical Foam

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Oct 30, 2017Actual

Completion Date

Oct 30, 2017Actual

First Submitted Date

Mar 2, 2017

First Submission Date that Met QC Criteria

Mar 9, 2017

First Posted Date

Mar 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2017

Last Update Posted Date

Jan 3, 2018Actual

Name	Class
LEO Pharma	INDUSTRY

Description Module

Brief Summary

Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.

Detailed Description

A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
Open Label Enstilar	Experimental	open label	Drug: Enstilar 0.005%-0.064% Topical Foam

Name	Type	Description	Arm Group Labels	Other Names
Enstilar 0.005%-0.064% Topical Foam	Drug	Topical foam	Open Label Enstilar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy	pga x bsa	16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Physician Global Assessment	PGA	16 weeks
Body Surface area	BSA	16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female adults ≥ 18 years of age.
Diagnosis of chronic plaque-type psoriasis.
Able to give written informed consent prior to performance of any study related procedures.
Treated with a biologic agent for a minimum of 24 weeks at baseline.
Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
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.

Exclusion Criteria:

>5% Body Surface Area
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 (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Jan 29, 2019
Reset	Feb 20, 2019
Release	Mar 14, 2024
Reset	Apr 8, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 29, 2019			Feb 20, 2019
Mar 14, 2024

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases