A Phase 4 interventional study of Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks in Psoriasis, sponsored by Bangladesh Medical University. Active, not recruiting at 1 site in Bangladesh. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Bangladesh Medical University · Phase 4, Interventional, and Treatment
Background:
Psoriasis is a chronic , immune-mediated inflammatory skin disorder affecting millions globally, the disease presents a major challenge to the physicians. When choosing a systemic therapy for moderate to severe plaque psoriasis, methotrexate is very good option, though its use is limited by its adverse effects. Several new treatments for psoriasis have appeared to be effective though they are not adequately investigated. Among them JAK inhibitors are leading clinical trials and can be a breakthrough in the treatment of psoriasis. Moreover, Very few studies have been performed to compare efficacy and safety of Deucravacitinib with Methotrexate therapy in the treatment of psoriasis.
Objective:
To assess Efficacy and Safety after commencement of therapy with Deucravacitinib and Methotrexate therapy in two different groups of patients with psoriasis.
Materials and Methods:
The study will be done on patients aged more than 18 years attending outpatient Department of Dermatology and Venereology department of Bangladesh Medical University.
This will be a longitudinal study. It will be conducted in the Department of Dermatology and Venereology of Bangladesh Medical University for 12 months from the acceptance of the protocol. Patients of psoriasis with PASI (Psoriasis Area and Severity Index) score 12 or more will be the study population. A total number 106 patients with psoriasis of both sexes will be enrolled. They will be divided in group A (53 patients) and group B (53 patients) according to inclusion and exclusion criteria In group A, patients will be treated with Deucravacitinib 6mg once daily for 6 months and efficacy will be assessed by PASI (Psoriasis Area and Severity Index) score periodically. In Group B, patients will be treated with Methotrexate 10 mg once weekly at night after meal, with folic acid 5mg tablet the day after taking methotrexate and efficacy will be assessed using PASI scoring tool. Finally efficacy and safety of two treatment modalities will be compared. Statistical analysis will be done with Chi square test, Fisher's exact test and multivariate linear regression for intergroup comparison safety assessment will be done on the basis of clinical history, examination and laboratory finding at each follow up. Adverse events will be explained to the patients. Ethical clearance will be obtained from Institutional Review Board of Bangladesh Medical University.
Ethical Consideration:
The nature and purpose of the study will be informed in details to all the participants. Before obtaining the consent, patients will be explained about the purpose and duration of the study, detailed study procedure, the benefits and potential risks (if any) involved with the study. Relevant investigations and therapeutic treatment will be given free of cost. Informed written consent will be taken from every patient before enrolment. Each and every patient will enjoy their rights to participate, refuse or withdraw from the study at any point of the study. Patients not willing to be a part of the study or not fulfilling the inclusion criteria will not be included. Patients who will deny to continue taking part in study will be treated as before. The investigator will also have the right to collect information about health condition, treatment and laboratory reports.
Expected Outcome:
This study can help to compare efficacy and safety of Deucravacitinib with Methotrexate in treatment of moderate to severe plaque psoriasis. If Deucravacitinib proves to be superior to methotrexate therapy, patients will be benefited and treatment related adverse effects will be reduced.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 106 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
For Deucravacitinib group (Group A) criteria:
For Methotrexate group (Group B) criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks
group B Methotrexate
Change in Psoriasis Area and Severity Index (PASI)
Assessment of the change in Erythema, Induration, Desquamation scores as measured by the Psoriasis Area and Severity Index(PASI) from baseline to 30 days. The PASI is a composite scoring system ranging from 0 to 72 ,where higher score indicate greater disease severity and worse clinical outcome.
Time frame: 30 days
Change in Pruritus Visual Analog Scale (PVAS)
Assessment of change in Pruritus Visual Analog Scale from baseline to 30 days. The PVAS measures itch severity. score range from 0 to 10 . Higher score indicate a worse outcome and greater symptom severity.
Time frame: 30 days
Adverse Effects
Monitoring, recording and evaluating any adverse events observed during the 30-day study period, including elevated liver function tests ( LFTs), and infection and drug-related reactions.
Time frame: 30 days
Dermatology Life Quality Index (DLQI) Score.
Assessment of the change in Dermatology Life Quality Index (DLQI )Score from baseline to 30 days to evaluate the impact on patients quality of life. The QLQI is a 10-question questionnaire used to measure the impact of skin disease on patients quality of life .total score 0 to 30.Higher score indicate a worse quality of life .
Time frame: 30 days
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Bangladesh Medical University