Back to resultsEfficacy and Safety of Apremilast in Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Apremilast 30mg
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: Diagnosed patients of chronic plaque psoriasis patients applicant for oral or parenteral treatments and for light therapy patients not responding to topical treatments Exclusion Criteria: Patients who show hypersensitive reactions to apremilast to any of its inactive component Pregnancy Lactating mothers
Sites / Locations
- Ghurki Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Apremilast 30 mg twice daily
Arm Description
Outcomes
Primary Outcome Measures
Psoriasis area and severity index
body surface area
Secondary Outcome Measures
Full Information
NCT ID
NCT06032858
First Posted
September 5, 2023
Last Updated
September 5, 2023
Sponsor
Ghurki Trust and Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06032858
Brief Title
Efficacy and Safety of Apremilast in Psoriasis
Official Title
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2022 (Actual)
Primary Completion Date
July 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ghurki Trust and Teaching Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Psoriasis is a long standing inflammatory, autoinflammatory disease linked with many comorbidities. Patients with moderate to severe plaque psoriasis can be managed with topical as well as systemic medications. FDA approved Apremilast as first drug to be taken orally in cases of psoriasis in mid 1990's. Currently, according to researchers best knowledge no study has been done on use of Apremilast in Pakistan. It has recently become available here. Keeping in view all the benefits of this drug, a study has been planned to check its effectiveness and safety 30mg twice a day, in patients with moderate to severe chronic plaque psoriasis based on Psoriasis area and severity index and Body surface area assessments in our population.
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apremilast 30 mg twice daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Apremilast 30mg
Intervention Description
Apremilast 30mg twice daily
Primary Outcome Measure Information:
Title
Psoriasis area and severity index
Time Frame
16 weeks
Title
body surface area
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed patients of chronic plaque psoriasis
patients applicant for oral or parenteral treatments and for light therapy
patients not responding to topical treatments
Exclusion Criteria:
Patients who show hypersensitive reactions to apremilast to any of its inactive component
Pregnancy
Lactating mothers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Haroon Nabi
Organizational Affiliation
Professor Department of Dermatology LMDC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dr. Saira Muaaz
Organizational Affiliation
Department of Dermatology Ghurki Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Hira Tariq
Organizational Affiliation
Senior Registrar Department of Dermatology Services Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Sumera Hanif
Organizational Affiliation
Senior Registrar Department of Dermatology LMDC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Talat Akbar
Organizational Affiliation
Associate Professor, Dermatology, LMDC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Faria Asad
Organizational Affiliation
Head of Department Dermatology SIMS/ Services Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ghurki Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22257911
Citation
Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol. 2012 Jun 15;83(12):1583-90. doi: 10.1016/j.bcp.2012.01.001. Epub 2012 Jan 10.
Results Reference
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PubMed Identifier
28416342
Citation
Crowley J, Thaci D, Joly P, Peris K, Papp KA, Goncalves J, Day RM, Chen R, Shah K, Ferrandiz C, Cather JC. Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for >/=156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2). J Am Acad Dermatol. 2017 Aug;77(2):310-317.e1. doi: 10.1016/j.jaad.2017.01.052. Epub 2017 Apr 14.
Results Reference
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Efficacy and Safety of Apremilast in Psoriasis
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