Apremilast versus methotrexate for moderate to severe plaque psoriasis
Comparison of Efficacy of Methotrexate vs Apremilast in Moderate to Severe Plaque Psoriasis
This test compares apremilast and methotrexate to see which works better for adults (18–60) with moderate to severe plaque psoriasis who have not had systemic therapy in the past 3 months.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Hayat Abad Medical Complex, Peshawar Government |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Peshawar, Khyber Pukhtunkhwa) |
| Trial ID | NCT07337434 on ClinicalTrials.gov |
What this trial studies
This interventional, early-phase study at a tertiary hospital in Peshawar will give participants with PASI ≥10 either methotrexate or apremilast and follow them for changes in skin disease severity and side effects. Clinical outcomes will include change in PASI scores and monitoring for adverse events, with particular attention to laboratory tests relevant to methotrexate (liver and blood counts) and safety signals for apremilast. The trial aims to provide head-to-head comparative data in a Pakistani population where direct comparisons are limited. Results are intended to help local clinicians balance effectiveness, tolerability, cost, and monitoring needs when choosing systemic therapy.
Who should consider this trial
Good fit: Adults aged 18–60 with moderate to severe plaque psoriasis (PASI ≥10), no systemic psoriasis treatment in the prior 3 months, and without pregnancy, major liver or renal dysfunction, or known drug hypersensitivity are the intended participants.
Not a fit: People with mild psoriasis, children, pregnant or breastfeeding individuals, or those with significant liver or kidney disease are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, the comparison could identify the better-tolerated and/or more effective oral option for regional patients, improving symptom control and treatment decisions.
How similar studies have performed: Previous international studies show apremilast generally has a more favorable tolerability profile but mixed efficacy compared with traditional systemic agents, and direct head-to-head data remain limited and variable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnancy or lactation History of liver or renal dysfunction Known hypersensitivity to study drugs
Where this trial is running
Peshawar, Khyber Pukhtunkhwa
- MTI-HMC Peshawar — Peshawar, Khyber Pukhtunkhwa, Pakistan (Recruiting)
Study contacts
- Study coordinator: Filza Ajmal, FCPS part 2
- Email: binteajmal1996@gmail.com
- Phone: +923008179226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.