Roflumilast Versus Methotrexate in Psoriasis

NCT05684744 | Completed Phase 2 FDA Drug

• 1 other identifier: Kapu27
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor, which is approved in its oral form for chronic obstructive pulmonary disease, and in its topical form in the treatment of plaque psoriasis. Methotrexate is one of the conventional systemic treatments of psoriasis, so the aim of this study is to compare the efficacy and safety of roflumilast and methotrexate in the treatment of psoriasis

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Psoriasis Severity Index (PASI) before and after Roflumilast

  Comparison of Psoriasis Severity Index (PASI) before and after treatment with Roflumilast, where the lower score indicates clinical improvement. PASI score ranges from 0-72.

  12 weeks

• Psoriasis Severity Index (PASI) change with Roflumilast Vs Methotrexate

  Comparison of change of Psoriasis Severity Index (PASI) after treatment with roflumilast and after treatment of methotrexate where the lower score indicates clinical improvement. PASI score ranges from 0-72.

  12 weeks

Study Arms (2)

Roflumilast

EXPERIMENTAL

oral roflumilast in a dose of 500 mcg per day

Drug: Roflumilast

Methotrexate

ACTIVE COMPARATOR

oral methotrexate in a dose of 0.2- 0.4 mg/kg/week

Drug: Methotrexate

Interventions

Roflumilast DRUG

The patients will receive oral roflumilast in a dose of 500 mcg per day for 12 weeks

Also known as: Roflumilast oral

Roflumilast

Methotrexate DRUG

The patients will receive methotrexate in a dose of 0.2- 0.4 mg/kg/week for 12 weeks

Also known as: Methotrexate tablets

Methotrexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with psoriasis vulgaris
• Psoriatic patients not receiving any relevant systemic treatment for at least 4 weeks before initiation of our study
• Psoriatic patients not receiving any relevant topical treatment for at least 2 weeks before initiation of our study

You may not qualify if:

• Erythrodermic or pustular psoriasis
• Pregnant and lactating females
• Patients with autoimmune diseases e.g. systemic lupus erythematosus
• Patients with solid or hematological malignancies e.g., breast cancer, leukemia, etc.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Roflumilast; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: January 9, 2023
• Primary Completion: May 9, 2023
• Study Completion: May 14, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)