PsoriasisPhase 4NCT07915492
Comparison of Efficacy and Safety of Deucravacitinib Versus Methotrexate in the Treatment of Moderate-to-Severe Plaque Psoriasis .
A Phase 4 study testing Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks in people with Psoriasis, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteBangladesh
- Study dates
- 14 Nov 2025to 13 Nov 2027
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age with moderate-to-severe plaque psoriasis PASI score of at least 6 .
- Patients with a history of prior therapy, including biologics were eligible for inclusion provided they completed the specified washout period (e.g., at least 12 weeks after the last dose of adalimumab) before randomization. (Bruce Strober, January 2023)
Who cannot join
- For Deucravacitinib group (Group A) criteria:
- Known hypersensitivity to Deucravacitinib.
- Patients with active infection including HIV.
- Clinically suspected or known case of tuberculosis.
- Taking immunosuppressive drugs like Corticosteroids, Cyclosporine, Mycophenolate Mofetil.
- Previous treatment with TYK2 inhibitors.
Show all 18Show fewer
- Presence of non-plaque forms of psoriasis (e.g., Guttate, Erythrodermic, Pustular).
- Significant hepatic, renal, or hematologic abnormalities.
- Pregnant or breastfeeding women(Chaplin 2023)
- For Methotrexate group (Group B) criteria:
- Pregnant women and lactating mother.
- Patients with active infection including HIV.
- Impaired hepatic and renal functions.
- Patients with Hb% <10g/dl, white blood cell count <3500/cumm, platelet count <100000/cumm.
- Patients with comorbid conditions e.g., Diabetes mellitus, obesity.
- Known hypersensitivity to Methotrexate
- Concomitant use of other drugs causing marrow suppression such as, cyclosporine.
- Alcoholic patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy and Safety of Deucravacitinib Versus Methotrexate in the Treatment of Moderate-to-Severe Plaque Psoriasis
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.
Read more
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.
- Conditions
- Psoriasis
- Being tested
- Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeksDrug
group B Methotrexate
| Study group | Role | What they receive |
|---|---|---|
| Participants in Group A will receive Deucravacitinib 6 mg ,Tablet once daily for 28 weeks. | Experimental | Not described Receives: Drug: Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (1)
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 .
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start14 Nov 2025
- Primary completion13 Nov 2026 (estimated)
- Study completion13 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Zahidul Islam, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915492
- Sponsor's protocol ID
- 5811
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
• Banerjee S, Thaçi D and Strober B (2025) 'Deucravacitinib in plaque psoriasis: Four-year safety and efficacy results from the Phase 3 POETYK PSO-1, PSO-2 and long-term extension Armstrong AW, Lebwohl M, Warren RB, Sofen H, Morita A, Paul C, Papp KA, Colombo MJ, Scotto J, Vaile J, Zhuo J, Vritzali E, Berger V, Schroeder G, trials', Journal of the European Academy of Dermatology and Venereology, 39(7):1336-1351, doi:10.1111/jdv.20553. • Armstrong AW, Warren RB, Zhong Y, Zhuo J, Cichewicz A, Kadambi A, Junqueira D, Westley T, Kisa R, Daamen C and Augustin M (2023) 'Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis', Dermatology and Therapy, 13(11):2839-2857, doi:10.1007/s13555-023-01034-7. • BANGERT CA and COSTNER MI (n.d.) 'Pi3k Inhibitors'. • Chaplin S (2023) 'Deucravacitinib for moderate to severe plaque psoriasis', Prescriber, 34(8-9):31-33, doi:10.1002/psb.2089. • 'Diagnosis_and_management_of_psoriasis' (n.d.). • Estevinho T, Lé AM and Torres T (2023) 'Deucravacitinib in the treatment of psoriasis', Journal of Dermatological Treatment, 34(1):2154122, doi:10.1080/09546634.2022.2154122. • 'Guidelines for the Diagnosis and Treatment of Psoriasis in China: 2019 Concise Edition#' (2020) International Journal of Dermatology and Venereology, 3(1):14-26, doi:10.1097/JD9.0000000000000074. • Hammerschmidt M and Mulinari Brenner F (2014) 'Efficacy and safety of methotrexate in alopecia areata', Anais Brasileiros de Dermatologia, 89(5):729-734, doi:10.1590/abd1806-4841.20142869. • Hoy SM (2022) 'Deucravacitinib: First Approval', Drugs, 82(17):1671-1679, doi:10.1007/s40265-022-01796-y. • Imafuku S, Okubo Y, Tada Y, Ohtsuki M, Colston E, Napoli A, Shao Y, Banerjee S and Morita A (2024) 'Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Deucravacitinib Versus Methotrexate in the Treatment of Moderate-to-Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07915492
- Acronym / sponsor ID
- 5811
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 13 Nov 2026 (estimated)
- Study completion
- 13 Nov 2027 (estimated)
- First posted
- 4 Nov 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Participants in Group A will receive Deucravacitinib 6 mg ,Tablet once daily for 28 weeks. | Experimental | Drug: Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults ≥18 years of age with moderate-to-severe plaque psoriasis PASI score of at least 6 .
- Patients with a history of prior therapy, including biologics were eligible for inclusion provided they completed the specified washout period (e.g., at least 12 weeks after the last dose of adalimumab) before randomization. (Bruce Strober, January 2023)
Key exclusion criteria (18 listed)
- Known hypersensitivity to Deucravacitinib.
- Patients with active infection including HIV.
- Clinically suspected or known case of tuberculosis.
- Taking immunosuppressive drugs like Corticosteroids, Cyclosporine, Mycophenolate Mofetil.
- Previous treatment with TYK2 inhibitors.
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 |
|---|---|---|
| Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeksgroup B Methotrexate | Drug | Participants in Group A will receive Deucravacitinib 6 mg ,Tablet once daily for 28 weeks. |
Primary outcome
Change in Psoriasis Area and Severity Index (PASI)
Time frame: 30 days
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.
Change in Pruritus Visual Analog Scale (PVAS)
Time frame: 30 days
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.
Adverse Effects
Time frame: 30 days
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.
1 secondary outcome
Dermatology Life Quality Index (DLQI) Score.
Time frame: 30 days
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 4 Nov 2026.
- Background• Banerjee S, Thaçi D and Strober B (2025) 'Deucravacitinib in plaque psoriasis: Four-year safety and efficacy results from the Phase 3 POETYK PSO-1, PSO-2 and long-term extension Armstrong AW, Lebwohl M, Warren RB, Sofen H, Morita A, Paul C, Papp KA, Colombo MJ, Scotto J, Vaile J, Zhuo J, Vritzali E, Berger V, Schroeder G, trials', Journal of the European Academy of Dermatology and Venereology, 39(7):1336-1351, doi:10.1111/jdv.20553. • Armstrong AW, Warren RB, Zhong Y, Zhuo J, Cichewicz A, Kadambi A, Junqueira D, Westley T, Kisa R, Daamen C and Augustin M (2023) 'Short-, Mid-, and Long-Term Efficacy of Deucravacitinib Versus Biologics and Nonbiologics for Plaque Psoriasis: A Network Meta-Analysis', Dermatology and Therapy, 13(11):2839-2857, doi:10.1007/s13555-023-01034-7. • BANGERT CA and COSTNER MI (n.d.) 'Pi3k Inhibitors'. • Chaplin S (2023) 'Deucravacitinib for moderate to severe plaque psoriasis', Prescriber, 34(8-9):31-33, doi:10.1002/psb.2089. • 'Diagnosis_and_management_of_psoriasis' (n.d.). • Estevinho T, Lé AM and Torres T (2023) 'Deucravacitinib in the treatment of psoriasis', Journal of Dermatological Treatment, 34(1):2154122, doi:10.1080/09546634.2022.2154122. • 'Guidelines for the Diagnosis and Treatment of Psoriasis in China: 2019 Concise Edition#' (2020) International Journal of Dermatology and Venereology, 3(1):14-26, doi:10.1097/JD9.0000000000000074. • Hammerschmidt M and Mulinari Brenner F (2014) 'Efficacy and safety of methotrexate in alopecia areata', Anais Brasileiros de Dermatologia, 89(5):729-734, doi:10.1590/abd1806-4841.20142869. • Hoy SM (2022) 'Deucravacitinib: First Approval', Drugs, 82(17):1671-1679, doi:10.1007/s40265-022-01796-y. • Imafuku S, Okubo Y, Tada Y, Ohtsuki M, Colston E, Napoli A, Shao Y, Banerjee S and Morita A (2024) 'Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Japanese patients with moderate to severe plaque, erythrodermic, or generalized pustular psoriasis: Efficacy and safety results
- Individual participant dataSharing planned: No
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Participants in group B will receive Methotrexate ,10mg tablets , once weekly for 28 weeks in people with Psoriasis, run by Bangladesh Medical University at 1 site in Bangladesh.
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 2 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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 Bangladesh. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area and Severity Index (PASI) (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07915492, which also lists 1 linked publication.
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 4 Nov 2026.