PsoriasisEarly Phase 1MTXNCT07261306
Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
A Early Phase 1 study testing Methotrexate and Tofacitinib in people with Psoriasis, run by Lahore General Hospital at 1 site in Pakistan.
Trial summary
Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Methotrexate and Tofacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Aug 2025to 25 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18- 70 years of either gender.
- Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included.
- Duration of plaque psoriasis for at least 6 months prior to the study.
- Psoriasis that has not shown adequate response to topical therapies
Who cannot join
- Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis.
- Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded.
- Known hypersensitivity or contraindications to either methotrexate or tofacitinib.
- History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy.
- Pregnant or lactating women will not be eligible for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Lahore general hospital
Lahore, Punjab Province
Dr Ayesha Wahid, Fcps, +92 323 4822177, zaeemakanwal@hotmail.com
About this study
Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study
Read the detailed description
Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study
- Conditions
- Psoriasis
- Being tested
- Methotrexate, Tofacitinib
- Keywords
- MtX, Tofacitinib
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment
TofacitinibDrug
Tofacitinib is janus kinase inhibitor and have role in psoriasis
| Study group | Role | What they receive |
|---|---|---|
| Group mTX | Active comparator | Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase Receives: Drug: Methotrexate |
| Tofacitinib | Active comparator | Tofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Achievement
The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as "Achieved" if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and "Not Achieved" if this threshold is not met.
Measured: Baseline to Week 12 of treatment
Secondary outcomes (1)
Percentage Reduction in PASI Score
This outcome will quantify the degree of improvement by calculating the percentage reduction in PASI score from baseline to Week 12. Percentage reduction will be computed using the formula:
[(Baseline PASI - Week-12 PASI) ÷ Baseline PASI] × 100.
Measured: From Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start29 Aug 2025
- Primary completion10 Dec 2025 (estimated)
- Study completion25 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maryam Fatima, Lahore General Hospital
- Investigators
- Maryam Fatima, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261306
- Sponsor's protocol ID
- Derma LGH
- Acronym
- MTX
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07261306
- Acronym / sponsor ID
- MTX / Derma LGH
- Conditions
- Psoriasis
- Keywords
- MtX, Tofacitinib
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 29 Aug 2025 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study
Detailed description
Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Group mTX | Active comparator | Drug: MethotrexateMethotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase |
| Tofacitinib | Active comparator | Drug: TofacitinibTofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18- 70 years of either gender.
- Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included.
- Duration of plaque psoriasis for at least 6 months prior to the study.
- Psoriasis that has not shown adequate response to topical therapies
Key exclusion criteria (5 listed)
- Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis.
- Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded.
- Known hypersensitivity or contraindications to either methotrexate or tofacitinib.
- History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy.
- Pregnant or lactating women will not be eligible for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateMethotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment | Drug | Group mTX |
| TofacitinibTofacitinib is janus kinase inhibitor and have role in psoriasis | Drug | Tofacitinib |
Primary outcome
Efficacy Achievement
Time frame: Baseline to Week 12 of treatment
The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as "Achieved" if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and "Not Achieved" if this threshold is not met.
1 secondary outcome
Percentage Reduction in PASI Score
Time frame: From Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maryam Fatima principal investigator
Lahore General Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Methotrexate and Tofacitinib in people with Psoriasis, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryam Fatima, Mbbs (03361409014, maryamfatima726@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy Achievement (time frame: Baseline to Week 12 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.