Chronic Plaque Psoriasis Clinical Trial
Official title:
Open-Label Study to Assess the Safety and Efficacy of Apremilast in Patients With Chronic Plaque Psoriasis Who Have Failed One Course of Biologic Therapy.
This is a Phase II, open label, investigator-initiated study to be done at Duke University Medical Center to treat adult patients (ages 18-80) with chronic plaque psoriasis who have failed Biologic Therapy with Apremilast 30 mg BID for 24 weeks. At the time of enrollment, the patient must have received biologic therapy without achieving a response of "almost clear" or "clear" according to PGA or has not responded with a 75% reduction of PASI score. Once deemed eligible, subjects will return for a baseline visit and receive Apremilast therapy and instructions. Subjects will be treated at weeks 0,4,8,12,16,20 and 24; subjects will be evaluated 28 days after last dose of Apremilast for safety and efficacy.
Data Analysis Data will be analyzed and reported after all subjects have completed follow-up
phase of study. All subsequent data collected will be analyzed and reported in a follow-up
clinical report.
Data & Safety Monitoring Dr. Murray will be following all laboratory values and adverse
events during this trial. In addition, Celgene will provide a study monitor to, at regular
intervals, review all data. All data will be reported to Celgene.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03598790 -
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT00799877 -
Chronic Plaque Psoriasis (Ps) Registry
|
||
| Completed |
NCT02581345 -
Phase 3 Study of M923 and Humira® in Subjects With Chronic Plaque-type Psoriasis
|
Phase 3 | |
| Not yet recruiting |
NCT00707070 -
Combining Acitretin and Efalizumab in the Therapy of Chronic Plaque Psoriasis
|
Phase 4 | |
| Terminated |
NCT00972543 -
Raptiva in Palm and Sole Psoriasis
|
Phase 4 | |
| Completed |
NCT00539929 -
Paired-Comparison Study Evaluating the Efficacy and Safety of E6201 Versus Vehicle for the Treatment of Plaque-Type Psoriasis
|
Phase 2 | |
| Completed |
NCT02852967 -
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
|
Phase 2 | |
| Completed |
NCT00770965 -
Phase II Efficacy Study Looking at a Single-dose of One of Three Dose Levels of AIN457 in Patients With Chronic Plaque-type Psoriasis
|
Phase 2 | |
| Active, not recruiting |
NCT06011733 -
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Chinese Adult Study Participants With Moderate to Severe Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT00245765 -
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
|
Phase 2 | |
| Completed |
NCT00673556 -
A Study to Assess the Efficacy and Safety of Alefacept in Psoriasis Patients for Whom Conventional Treatment is Ineffective or Inappropriate
|
Phase 3 | |
| Terminated |
NCT00844363 -
Narrowband UVB Phototherapy in the Treatment of Psoriasis Vulgaris
|
N/A | |
| Completed |
NCT00574249 -
Adalimumab in Combination With Topical Treatment (Calcipotriol/Betamethasone) in Subjects With Moderate to Severe Psoriasis and Insufficient Response to Classic Systemic Treatment
|
Phase 3 | |
| Completed |
NCT00512187 -
Moderate Weight Loss Makes Obese Patients With Severe Chronic Plaque Psoriasis Responsive to Sub-Optimal Dose of Cyclosporine: an Investigator Blinded, Controlled, Randomized Clinical Trial
|
Phase 4 | |
| Completed |
NCT02570750 -
The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis
|
||
| Completed |
NCT00438360 -
Efficacy and Safety of Cyclosporine A Microemulsion in Maintenance Patients With Chronic Plaque Psoriasis
|
Phase 3 | |
| Active, not recruiting |
NCT03897075 -
Efficacy and Safety Study of Tildrakizumab in the Treatment of Nail Psoriasis
|
Phase 3 | |
| Completed |
NCT01358578 -
Safety and Efficacy of Secukinumab Compared to Etanercept in Subjects With Moderate to Severe, Chronic Plaque-Type Psoriasis
|
Phase 3 | |
| Completed |
NCT03536884 -
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
|
Phase 3 | |
| Completed |
NCT03230292 -
A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis
|
Phase 2 |