A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides

A Phase 1 Dose-escalation Study of Topical Duvelisib in Patients With Early-stage Mycosis Fungoides

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

Study Overview

• Status: Not yet recruiting
• Conditions: Mycosis Fungoides; Cutaneous T-cell Lymphoma
• Intervention / Treatment: Drug: Duvelisib

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Medical Director; Phone Number: 1-858-251-1414; Email: TopicalStudy@securabio.com

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duvelisib	Drug: Duvelisib; Topical gel; Other Names: SBI-0145

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score	Baseline through Day 114
Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score	Baseline, Day 114

Collaborators and Investigators

• Sponsor: SecuraBio
• Investigators: Study Director: Reuven Chantre, MD, Secura Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Topical; Duvelisib; Early-stage mycosis fungoides
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Hemic and Lymphatic Diseases; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; duvelisib
• Other Study ID Numbers: SBI-0145-C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No