Efficacy and Safety of Apremilast in Psoriasis

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ClinicalTrials.gov Identifier: NCT06032858

Recruitment Status : Completed

First Posted : September 13, 2023

Last Update Posted : September 13, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Ghurki Trust and Teaching Hospital

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Drug: Apremilast 30mg	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis
Actual Study Start Date :	March 6, 2022
Actual Primary Completion Date :	July 10, 2023
Actual Study Completion Date :	August 10, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Drug Information available for: Apremilast

Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Apremilast 30 mg twice daily	Drug: Apremilast 30mg Apremilast 30mg twice daily

Outcome Measures

Primary Outcome Measures :

Psoriasis area and severity index [ Time Frame: 16 weeks ]
body surface area [ Time Frame: 16 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06032858

Locations

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Pakistan
Ghurki Hospital
Lahore, Punjab, Pakistan, 54000

Sponsors and Collaborators

Ghurki Trust and Teaching Hospital

Investigators

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Study Director:	Prof. Dr. Haroon Nabi	Professor Department of Dermatology LMDC
Principal Investigator:	Dr. Saira Muaaz	Department of Dermatology Ghurki Hospital
Study Chair:	Dr. Hira Tariq	Senior Registrar Department of Dermatology Services Hospital
Study Chair:	Dr. Sumera Hanif	Senior Registrar Department of Dermatology LMDC
Study Chair:	Dr. Talat Akbar	Associate Professor, Dermatology, LMDC
Study Chair:	Prof. Dr. Faria Asad	Head of Department Dermatology SIMS/ Services Hospital

More Information

Publications:

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.

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.

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Responsible Party:	Ghurki Trust and Teaching Hospital
ClinicalTrials.gov Identifier:	NCT06032858
Other Study ID Numbers:	D6
First Posted:	September 13, 2023 Key Record Dates
Last Update Posted:	September 13, 2023
Last Verified:	September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Apremilast Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Phosphodiesterase 4 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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