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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03236870 -
A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
|
||
| Completed |
NCT00078819 -
Etanercept (Enbrel®) in Psoriasis - Pediatrics
|
Phase 3 | |
| Completed |
NCT04841187 -
Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
|
||
| Active, not recruiting |
NCT03927352 -
The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03284879 -
Post-Marketing Surveillance Study of OTEZLA
|
||
| Recruiting |
NCT06027034 -
Effectiveness of a Digital Health Application for Psoriasis
|
N/A | |
| Not yet recruiting |
NCT06050330 -
CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study
|
N/A | |
| Recruiting |
NCT05744466 -
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
|
||
| Completed |
NCT04149587 -
A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
|
||
| Completed |
NCT01384630 -
Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis
|
Phase 2 | |
| Completed |
NCT03998683 -
A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis
|
Phase 3 | |
| Terminated |
NCT03556202 -
A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)
|
Phase 3 | |
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Recruiting |
NCT06077331 -
A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT04316585 -
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
|
Phase 1 | |
| Completed |
NCT04894890 -
A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
|
||
| Completed |
NCT00358384 -
Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034
|
Phase 1 | |
| Completed |
NCT03757013 -
A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
|
||
| Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
| Completed |
NCT05003531 -
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis
|
Phase 2 |