A Study of Topical Duvelisib in Participants With Early-stage Mycosis Fungoides (NCT07714187)

01

Study summary

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

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Conditions studied

Mycosis Fungoides
Cutaneous T-cell Lymphoma

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Keywords

Early-stage mycosis fungoides
Duvelisib
Topical

03

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

04

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential assignment
Masking: None (open label)
Enrollment: 30 participants (estimated)

Study arms

Experimental
Duvelisib
Drug: Duvelisib

Interventions

DrugDuvelisib
Topical gel
Also known as: SBI-0145

05

What researchers measure

Primary outcomes

Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
Time frame: After each treatment administration up to Day 114
Maximum Tolerated Dose (MTD) of Duvelisib Topical Gel
Time frame: Up to 28 days
Recommended Phase 2 Dose (RP2D) of Duvelisib Topical Gel
Time frame: Up to 28 days

Secondary outcomes

Pharmacokinetics: Plasma Concentration of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Time to Maximum Plasma Concentration (Tmax) of Duvelisib Topical Gel
Time frame: Days 1, 2, and 28 (pre-dose, up to 6 hours post-dose)
Pharmacokinetics: Area Under the Curve (AUC) of Duvelisib Topical Gel
Time frame: 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
Time frame: Baseline through Day 114
Number of Participants Achieving a ≥50% Reduction from Baseline in Total mCAILS Score
Time frame: Baseline through Day 114
Change from Baseline in Total Modified Severity-weighted Assessment Tool (mSWAT) Score
Time frame: Baseline, Day 114

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Study locations

1 site

Johns Hopkins University
Baltimore, Maryland 21218, United States

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID: NCT07714187
Lead sponsor: SecuraBio
Responsible party: Sponsor
First posted: Jul 20, 2026
Start date: Jan 2027 (estimated)
Primary completion: Oct 2028 (estimated)
Completion: Jan 2029 (estimated)
Last update: Jul 20, 2026

Study contacts

Medical Director

Contact

TopicalStudy@securabio.com

1-858-251-1414

Reuven Chantre, MD

study director · Secura Bio, Inc.

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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