NCT07714187

Brief Summary

This study will evaluate the safety and preliminary efficacy of duvelisib topical gel in participants with early-stage mycosis fungoides.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
24mo left

Started Jan 2027

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.8 years

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Mycosis FungoidesCutaneous T-cell Lymphoma

Keywords

Early-stage mycosis fungoidesDuvelisibTopical

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Baseline through Day 114

  • Local Skin Reactions to Duvelisib Topical Gel

    Local skin reactions will be measured as a local skin reaction score using a four-point post-treatment assessment severity scale.

    After each treatment administration up to Day 114

  • 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

Secondary Outcomes (7)

  • Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel

    Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel

    Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  • Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel

    Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  • Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel

    Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)

  • Proportion of Treated Lesions Achieving >50% Improvement from Baseline Based on Modified Composite Assessment of Index Lesion Severity (mCAILS) Score

    Baseline through Day 114

  • +2 more secondary outcomes

Study Arms (1)

Duvelisib

EXPERIMENTAL
Drug: Duvelisib

Interventions

DuvelisibDRUG

Topical gel

Also known as: SBI-0145
Duvelisib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a clinical diagnosis of Stage IA, Stage IB, or Stage IIA mycosis fungoides (cutaneous T-cell lymphoma), without clinically significant lymphadenopathy (≥1.5 centimeters).
  • Have 3 to 5 active, treatment-accessible mycosis fungoides lesions; ulcerated lesions and lesions to the face, neck, inguinal folds and intergluteal cleft are not considered suitable for administration of study drug.
  • Have baseline organ function (without transfusion support within 30 days of Cycle 1 Day 1) as defined by the protocol.

You may not qualify if:

  • Have Stage IIB to IVB mycosis fungoides or Sezary syndrome.
  • Have histopathologically confirmed lymph node involvement.
  • Received systemic treatment with a phosphoinositide 3-kinases inhibitor in the 60 days prior to starting study drug.
  • Received topical steroids or other topical treatment (for example, nitrogen mustard) on mycosis fungoides lesions in the 2 weeks prior to starting study drug. Participants who receive such agents may become eligible for the study after a 14-day washout period.
  • Received systemic steroids, immunosuppressants (for example, cyclosporine, prednisone), psoralen ultraviolet A radiation therapy, narrow-band ultraviolet B light therapy, carmustine or other systemic therapies for mycosis fungoides in the 3 weeks prior to starting study drug.
  • Received electron beam irradiation within the 3 months prior to starting study drug.
  • Note: other protocol-defined criteria apply.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

MeSH Terms

Conditions

Mycosis FungoidesLymphoma, T-Cell, Cutaneous

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Reuven Chantre, MD

    Secura Bio, Inc.

    STUDY DIRECTOR

Central Study Contacts

Medical Director

CONTACT

1-858-251-1414TopicalStudy@securabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)