Efficacy and Safety of Apremilast in Psoriasis

NCT06032858 | Completed Phase 4

• 1 other identifier: D6
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Psoriasis area and severity index

  16 weeks

• body surface area

  16 weeks

Study Arms (1)

Apremilast 30 mg twice daily

EXPERIMENTAL

Drug: Apremilast 30mg

Interventions

Apremilast 30mg DRUG

Apremilast 30mg twice daily

Apremilast 30 mg twice daily

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed patients of chronic plaque psoriasis
• patients applicant for oral or parenteral treatments and for light therapy
• patients not responding to topical treatments

You may not qualify if:

• Patients who show hypersensitive reactions to apremilast to any of its inactive component
• Pregnancy
• Lactating mothers

Sponsors & Collaborators

• Ghurki Trust and Teaching Hospital: lead

Study Sites (1)

Ghurki Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 22257911 BACKGROUND

• 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.

  PMID: 28416342 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Prof. Dr. Haroon Nabi

  Professor Department of Dermatology LMDC

  STUDY DIRECTOR

• Dr. Saira Muaaz

  Department of Dermatology Ghurki Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 13, 2023
• Study Start: March 6, 2022
• Primary Completion: July 10, 2023
• Study Completion: August 10, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)