NCT07337434

Brief Summary

This study aims to compare efficacy of methotrexate vs apremilast in the management of chronic plaque psoriasis.Given the high prevalence of psoriasis in Pakistan and the significant psychological impact on patients, particularly in Peshawer,this study will provide valuable insights into optimal treatment strategies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P75+ for early_phase_1

Timeline
2mo left

Started Dec 2025

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Dec 2025Jun 2026

First Submitted

Initial submission to the registry

December 17, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

December 25, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2026

Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 17, 2025

Last Update Submit

January 7, 2026

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • PASI SCORE calculation

    Efficacy of drugs are measured by calculation of PASI score for both groups at each visit.A treatment will be deemed effective if it achieves 75% reduction in PASI score from the baseline in 12 weeks. Score ranges from 0 (no disease) to 72( maximums severity) Interpretation: 0-5 mild 6-10 moderate \>10 severe

    3 months

Study Arms (2)

Methotrexate

EXPERIMENTAL

This group will recieve methotrexate 10-25mg once weekly for 3 months,

Drug: Methotrexate

Apremilast

EXPERIMENTAL

This group will recieve apremilast 30mg BD for 3 months.

Drug: Apremilast

Interventions

MethotrexateDRUG

Group A will recieve methotrexate 10-25mg once weekly for 3 months. Along with folic acid once daily except on day of methotrexate.

Methotrexate
ApremilastDRUG

Group B will recieve tablet apremilast 30mg twice daily for 3 months.

Apremilast

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having age between 18-60 years of either gender Diagnosed with moderate to severe plaque psoriasis (PASI ≥10) No prior systemic therapy in past 3 months.

You may not qualify if:

  • Pregnancy or lactation History of liver or renal dysfunction Known hypersensitivity to study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MTI-HMC Peshawar

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Interventions

Methotrexateapremilast

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Filza Ajmal, FCPS part 2

CONTACT

+923008179226binteajmal1996@gmail.com

Ghafoor Ullah

CONTACT

923335939818dr_ghafoorullah@yahoo.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Training medical officer

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 13, 2026

Study Start

December 25, 2025

Primary Completion (Estimated)

June 25, 2026

Study Completion (Estimated)

June 25, 2026

Last Updated

January 13, 2026

Record last verified: 2025-12

Locations

PA(1)