Roflumilast in Psoriasis vulgaris: CTRI/2026/03/0106289 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: 28 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 3
Clinical phase
Not Yet Recruiting
Recruitment status
330
Planned enrollment
Timing not reported
Primary-completion proxy
Executive view
CTRI/2026/03/0106289 evaluates Roflumilast in Psoriasis vulgaris. The disclosed sponsor is Sponsor not reported, the design is Interventional, and the geographic footprint is India. The first listed primary endpoint is not reported, assessed over an unreported time frame.
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 CTRI/2026/03/0106289 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Psoriasis vulgaris landscape. Drug & Asset MCP drug_fetch was queried for Roflumilast, while Company & Deal Intelligence MCP organization_fetch was queried for Sponsor not reported.
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 |
|---|---|---|---|---|---|---|
| CTRI/2026/03/0106289 | Roflumilast | Phase 3 / Not Yet Recruiting | Sponsor not reported | India | Timing not reported | |
| PACTR202603828332085 | Betamethasone | Not Applicable / Complete | Sponsor not reported | Egypt | Timing not reported | |
| NCT07443956 | Tirzepatide | Not Applicable / Recruiting | NHS Greater Glasgow and Clyde | United Kingdom | Correlation of molecular changes in biopsies (skin, synovial and adipose) with weight loss 12 weeks | 2028-02-01 |
| NCT07432386 | Apremilast | Phase 4 / Not yet recruiting | Sponsor not reported | Pakistan | Change in Dermatology Life Quality Index (DLQI) Score 8 weeks | 2026-10-14 |
| NCT07432815 | Escitalopram Oxalate | Phase 4 / Recruiting | Cairo University | Egypt | comparison of Percentage change in PASI score from baseline to 6 months between group A and B 6 months | 2026-12-01 |
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
CTRI/2026/03/0106289 is a Phase 3, not yet recruiting study with 330 planned participants. Allocation is not reported, masking is not reported, and the intervention model is not reported.
The primary endpoint is “not reported” over “not reported.” The retrieved endpoint description is: To assess the efficacy profile of Roflumilast 0.3% cream versus Calcipotriol 5 mcg cream in patient with Plaque Psoriasis.Timepoint: At Week 16.
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 330 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
The protocol identifies Calcipotriene 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
5 recent result records were selected as contextual evidence for Psoriasis vulgaris. These records do not establish direct evidence for CTRI/2026/03/0106289 unless the registration number matches.
Real-world outcomes of deucravacitinib in Chinese plaque psoriasis patients: a 24-week prospective study
Phase 4; n=101; PASI75(24-week) = 77.2 % Source: https://pubmed.ncbi.nlm.nih.gov/41769731/
A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis
Phase 3; n=337; Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) = 26.1 percentage of participants ; Percentage of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs) = 33.3 percentage of participants Source: https://clinicaltrials.gov/ct2/show/results/NCT04286607
Secukinumab biosimilar BAT2306 versus reference secukinumab in patients with moderate-to-severe plaque psoriasis: a multicentre, double-blind, randomised, active-controlled, phase…
Phase 3; n=502; Adverse Event: nasopharyngitis = The most common treatment-emergent adverse events were upper respiratory tract infections and nasopharyngitis. Source: https://pubmed.ncbi.nlm.nih.gov/42372782/
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
Roflumilast is indexed as Small molecule drug with PDE4 biology and a global stage of Approved. The asset profile lists Takeda Pharmaceutical Co., Ltd. as an originator or developer.
No exact Company & Deal Intelligence profile was returned for Sponsor not reported. Sponsor identity is retained from the trial protocol without adding unsupported corporate claims.
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 Roflumilast 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: CTRI/2026/03/0106289
Protocol source: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=154852
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: 28 September 2026.
Roflumilast in Psoriasis vulgaris is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes the primary endpoint and Timing not reported the leading decision points.
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