NCT07714187 Duvelisib hydrate Mycosis Fungoides Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07714187 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07714187 is a hot trial to watch
Mycosis Fungoides is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07714187 is notable because it evaluates Duvelisib hydrate in a Phase 1 design sponsored by Secura Bio, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07714187 |
| Official title | A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | Duvelisib hydrate |
| Sponsor | Secura Bio, Inc. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Number of Participants with Treatment-emergent Adverse Events (TEAEs) |
| Endpoint time frame | Baseline through Day 114 |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.
Allocation is N/A, masking is None (Open Label), and the intervention model is Sequential Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Baseline through Day 114)
- Local Skin Reactions to Duvelisib Topical Gel (After each treatment administration up to Day 114) — Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.
- Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel (Up to 28 days)
- Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel (Up to 28 days)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Duvelisib hydrate is indexed as Small molecule drug, with target PI3Kγ x PI3Kδ, mechanism PI3Kγ inhibitors, PI3Kδ inhibitors, and global highest development status Approved.
Company & Deal Intelligence MCP profile: Secura Bio, Inc. is resolved to a normalized organization record in CLARK COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07714187 provides a focused lens on Mycosis Fungoides development. Its value will be determined by whether Duvelisib hydrate can convert the current Phase 1 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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