Back to results

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Primary Purpose

Psoriasis

Status

Unknown status

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Otezla

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female adult ≥ 18 years of age;
Diagnosis of chronic plaque-type psoriasis
Moderate to severe plaque type psoriasis as defined at baseline by:
- PGA score of 3 or greater
- BSA affected by plaque-type psoriasis of 10% or greater
- PASI ≥ 12
Able and willing to give written informed consent prior to performance of any study-related procedures
Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).

Exclusion Criteria:

Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis
Subjects who previously used any biologic agent for psoriasis.
Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine).
Patient used topical therapies to treat psoriasis on the hands and/or feet 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.

Sites / Locations

Psoriasis Treatment Center of Central New JerseyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Otezla

Arm Description

Otezla BID

Outcomes

Primary Outcome Measures

Psoriasis Area Severity Index 75 at week 12

Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Secondary Outcome Measures

Full Information

NCT ID

NCT03587194

First Posted

July 2, 2018

Last Updated

August 27, 2018

Sponsor

Psoriasis Treatment Center of Central New Jersey

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03587194

Brief Title

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

Official Title

A Single Center Study to Evaluate the Effectiveness and Safety of Add on Enstilar® in Patients Using OTEZLA® for Moderate to Severe Plaque Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

July 23, 2018 (Actual)

Primary Completion Date

July 1, 2019 (Anticipated)

Study Completion Date

September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Psoriasis Treatment Center of Central New Jersey

Collaborators

Celgene Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Patients with moderate to severe plaque psoriasis will be treated with Otezla BID. At week 8, non responders will be discontinued, partial responders will be given add-on Enstilar QD for 4 weeks and PASI 75 responders will remain on Otezla monotherapy through week 16.

Detailed Description

50 adult patients with moderate to severe plaque psoriasis will be given OTEZLA® for 8 weeks. At week 8, patients who achieved between PASI 25-74 response will receive 4 weeks of Enstilar® (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% in addition to continuing OTEZLA® therapy. Patients who do not meet PASI 25 at week 8 will be discontinued from the study. At week 12 (after 4 consecutive weeks of Enstilar® add on therapy), Enstilar® will be discontinued and these patients will continue Otezla® as monotherapy through week 16. Patients who achieve PASI 75 at week 8 will remain enrolled on Otezla® monotherapy through week 16.

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Otezla

Arm Type

Experimental

Arm Description

Otezla BID

Intervention Type

Drug

Intervention Name(s)

Otezla

Intervention Description

Otezla 30mg BID

Primary Outcome Measure Information:

Title

Psoriasis Area Severity Index 75 at week 12

Description

Patients who achieve Psoriasis Area Severity Index 75 at week 12. PASI scores range 0-72 (maximal disease)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female adult ≥ 18 years of age; Diagnosis of chronic plaque-type psoriasis Moderate to severe plaque type psoriasis as defined at baseline by: PGA score of 3 or greater BSA affected by plaque-type psoriasis of 10% or greater PASI ≥ 12 Able and willing to give written informed consent prior to performance of any study-related procedures Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions). Exclusion Criteria: Other than psoriasis, any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled. Forms of psoriasis other than chronic plaque-type (e.g., Pustular erythrodermic and/or guttate psoriasis) or drug induced psoriasis Subjects who previously used any biologic agent for psoriasis. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin and cyclosporine). Patient used topical therapies to treat psoriasis on the hands and/or feet 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jerry Bagel, MD

Phone

6094434500

dreamacres1@aol.com

First Name & Middle Initial & Last Name or Official Title & Degree

Elise Nelson

Phone

6094434500

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

Jalyssa Delvalle

Phone

609-443-4500

Ext

1416

jdelvalle@windsordermatology.com

First Name & Middle Initial & Last Name & Degree

Elise Nelson

Phone

6094434500

enelson@windsordermatology.com

First Name & Middle Initial & Last Name & Degree

Jerry Bagel, MD

First Name & Middle Initial & Last Name & Degree

Brian Keegan, MD, PhD

First Name & Middle Initial & Last Name & Degree

David Nieves, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of Add on Enstilar in Patients Using Otezla for Psoriasis

We'll reach out to this number within 24 hrs