Psoriasis Clinical Trial
Official title:
Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
NCT number | NCT06032858 |
Other study ID # | D6 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 6, 2022 |
Est. completion date | August 10, 2023 |
Verified date | September 2023 |
Source | Ghurki Trust and Teaching Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 10, 2023 |
Est. primary completion date | July 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 59 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Pakistan | Ghurki Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Ghurki Trust and Teaching Hospital |
Pakistan,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Psoriasis area and severity index | 16 weeks | ||
Primary | body surface area | 16 weeks |
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