Methotrexate Sodium in Psoriasis of scalp: NCT07169019 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 15 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Early Phase 1
Clinical phase
Recruiting
Recruitment status
not reported
Planned enrollment
2026-08-20
Primary-completion proxy
Executive view
NCT07169019 evaluates Methotrexate Sodium in Psoriasis of scalp. The disclosed sponsor is Alexandria University, the design is Interventional, and the geographic footprint is Egypt. The first listed primary endpoint is To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone., assessed over One year.
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07169019 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Psoriasis of scalp landscape. Drug & Asset MCP drug_fetch was queried for Methotrexate Sodium, while Company & Deal Intelligence MCP organization_fetch was queried for Alexandria University.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT07169019 | Methotrexate Sodium | Early Phase 1 / Recruiting | Alexandria University | Egypt | To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis pat… One year | 2026-08-20 |
| NCT07373847 | Recaticimab | Phase 4 / Not yet recruiting | Xiangya Hospital Central South University | Geography not reported | PASI 100 response rate at week 16 in the group treated with vunakizumab combined with recaticimab versus vunakizumab co… From enrollment to the end of treatment at 16 weeks | 2027-06-30 |
| NCT07366268 | Apremilast | Not Applicable / Not yet recruiting | Assiut University | Geography not reported | Change in Psoriasis thickness,erythema, and scaling (TES score) from baseline to Week 12 Baseline to week 12 and two months after to detect recurrence . | 2027-05-01 |
| NCT07362017 | Ponesimod | Phase 3 / Recruiting | Vanda Pharmaceuticals, Inc. | United States | Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs) Through study completion, approximately 1 year | 2028-08-01 |
| NCT07357831 | Betamethasone Dipropionate/Calcipotriene | Phase 3 / Completed | Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd. | China | Physician's Global Assessment (PGA) success rate on the body (trunk and/or limbs) after 8 weeks of treatment with MC2-0… Baseline and 8-week | 2026-08-06 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT07169019 is a Early Phase 1, recruiting study with not reported planned participants. Allocation is Randomized, masking is Double, and the intervention model is Parallel Assignment.
The primary endpoint is “To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone.” over “One year.” The retrieved endpoint description is: The composition of gut microbiota before the start of treatment and after the end of the treatment course will be determined by analysis of a stool sample from each participant by illumina Next generation sequencing and 16S Metagenomics bioinformatics analysis of data to identify microbial taxa in the samples. The clinical impact induced by treatment of newly diagnosed psoriatic patients with probiotics and methotrexate or methotrxate alone will be determined by the calculation of PASI score before and after treatment..
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Methotrexate Sodium as control therapy. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
0 recent result records were selected as contextual evidence for Psoriasis of scalp. These records do not establish direct evidence for NCT07169019 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Methotrexate Sodium is indexed as Small molecule drug with DHFR biology and a global stage of Approved. The asset profile lists Endo International Plc as an originator or developer.
Alexandria University is indexed in an unreported country with the website http://www.alexu.edu.eg. A public research university in Alexandria, Egypt. The record lists 31 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Methotrexate Sodium is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT07169019
Protocol source: https://clinicaltrials.gov/study/NCT07169019
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 15 October 2026.
Methotrexate Sodium in Psoriasis of scalp is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes To identify the changes in gut microbiome and the clinical impact induced by treatment of newly diagnosed psoriasis patients with probiotics and methotrexate, compared to the standard treatment with methotrexate alone. and 2026-08-20 the leading decision points.
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