Roflumilast in Pruritus: NCT07560618 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: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 4
Clinical phase
Recruiting
Recruitment status
40
Planned enrollment
2027-08-01
Primary-completion proxy
Executive view
NCT07560618 evaluates Roflumilast in Pruritus. The disclosed sponsor is Integrative Skin Science and Research, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Number of descriptors (besides itch) used to describe skin sensations associated with AD, assessed over From enrollment to end of treatment at 4 weeks..
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 NCT07560618 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Pruritus landscape. Drug & Asset MCP drug_fetch was queried for Roflumilast, while Company & Deal Intelligence MCP organization_fetch was queried for Integrative Skin Science and Research.
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 |
|---|---|---|---|---|---|---|
| NCT07560618 | Roflumilast | Phase 4 / Recruiting | Integrative Skin Science and Research | United States | Number of descriptors (besides itch) used to describe skin sensations associated with AD From enrollment to end of treatment at 4 weeks. | 2027-08-01 |
| NCT07558668 | SYX-5219 | Phase 1 / Recruiting | Sitryx Therapeutics Ltd. | United States, Ireland, Denmark, United Kingdom, Bulgaria, Germany | The Proportion of Participants With Treatment-Emergent Adverse Events Adverse events are collected from the date of consent until up to 10… | 2026-08-30 |
| CTRI/2026/04/109774 | Tofacitinib Citrate | Phase 4 / Not Yet Recruiting | Sponsor not reported | India | Timing not reported | |
| NCT07549750 | HXN-5003 | Phase 1 / Not yet recruiting | Helixon Biotechnology (Suzhou) Co., Ltd | Australia | Safety and tolerability of HXN5003 in healthy participants following single dose Baseline to Day 197 | 2027-03-18 |
| NCT07549984 | IBI-3033 | Phase 1 / Not yet recruiting | Innovent Biologics (Suzhou) Co. Ltd. | China | Incidence of adverse events (AEs)/serious adverse events (SAEs) Up to 16 weeks | 2027-02-10 |
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
NCT07560618 is a Phase 4, recruiting study with 40 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.
The primary endpoint is “Number of descriptors (besides itch) used to describe skin sensations associated with AD” over “From enrollment to end of treatment at 4 weeks..” The retrieved endpoint description is: Participants will download and install the ExpiWell app. Descriptive classification of itch will be captured in the app. The number of descriptions selected by the participant will be tabulated to assess if there is more than just a description of itch for their skin sensation..
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 40 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. 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 Pruritus. These records do not establish direct evidence for NCT07560618 unless the registration number matches.
Sustained on/off-treatment disease control with abrocitinib for moderate-to-severe atopic dermatitis
Phase 3; n=not reported; DLQI = 3.5 Point Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42165315/
Benefit–risk profile comparison between dupilumab and upadacitinib: a structured benefit–risk assessment of the Heads Up trial
Phase 3; n=385; Benefit-risk score = 61.0 point ; Benefit-risk score = 66.0 point Source: https://pubmed-ncbi-nlm-nih-gov.libproxy1.nus.edu.sg/42223292/
A Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of OpSCF in the Treatment of Adult Subjects With Moderate to Severe Atopic Derma…
Phase 2; n=50; Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16(Least Squares Mean): Least Square (LS) Mean Difference = -20.484(90% CI, -40.6573 to -0.3103), P-Value = 0.095; Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 16(Least Squares Mean): Least Square (LS) Mean Difference = -20.484(90% CI, -40.6573 to -0.3103), P-Value = 0.095 Source: https://clinicaltrials.gov/ct2/show/results/NCT06101823
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.
Integrative Skin Science and Research is indexed in an unreported country. The organization record is used to resolve sponsor identity. The record lists an unreported number of 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 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: NCT07560618
Protocol source: https://clinicaltrials.gov/study/NCT07560618
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: 18 September 2026.
Roflumilast in Pruritus is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Number of descriptors (besides itch) used to describe skin sensations associated with AD and 2027-08-01 the leading decision points.
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